StrokeNCT03548090
The Effects of Plantar Flexion Training in People With Chronic Stroke
A study testing Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Skateboard exercise at an incline angle of 5 degrees and 50% body weight and Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight in people with Stroke and Hemiplegic Gait, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study consists of three phases that aim to develop an exercise intervention to promote maximal activation of ankle plantar flexors in the paretic lower extrimty (LE) in order to restore a more normalized gait pattern in chronic stroke survivors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiplegic Gait
- What is being tested?
- Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Skateboard exercise at an incline angle of 5 degrees and 50% body weight and Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 1 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be able to perform five times sit to stand test without the use of upper extremities
- Must have 10 degrees of passive ankle dorsiflexion measured in standing
- Must be able to walk with supervision level assistance with no assistive device
Who cannot join
- Currently receiving physical therapy
- History of orthopedic ankle instability
- Lacking knee extension to neutral
- Unable to understand English
- Unable to follow multi-step commands
- History of orthopedic pathology that prevents completion of experimental condition
Show all 9Show fewer
- Pain with weight bearing on paretic LE
- Received Botox to the plantar flexors within the last three months or phenol injections within the last six months
- Walk with a longer nonparetic step length than paretic step length
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
Official title: The Effects of Plantar Flexion Training on Plantar Flexion Activation, Torque, and Step Length Asymmetry in People With Chronic Stroke
This study consists of three phases that aim to develop an exercise intervention to promote maximal activation of ankle plantar flexors in the paretic lower extrimty (LE) in order to restore a more normalized gait pattern in chronic stroke survivors.
The aim of the first phase is to determine if there are differences between standing on different levels of inclination on plantar flexion activation during forward movement of the contralateral LE in adults with chronic with stroke.
Read more
The aim of second phase is to determine if there are differences between different percentages of weight bearing on the paretic LE on plantar flexion activation during forward movement of the contralateral LE in adults with chronic stroke.
The aim of the third phase is to determine if there are differences between a 4-week plantar flexion training intervention and conventional physical therapy.
Read the detailed description
Description of Arms:
This study has three phases. The first phase is performed in a cross-over fashion. Participants will stand on two different incline angles on the paretic LE and simultaneously move a small skateboard forward with the non-paretic LE. The testing order for the two different incline angles will be randomized, and all participants will be required to complete both incline angle conditions within a single test session.
The second phase will also be performed in a cross-over fashion. Participants will stand with three different percentages of body weight on their paretic LE while moving the skateboard forward with the non-paretic LE. The testing order for the three body weight percentages will be randomized. All participants will be required to complete all three body weight conditions within a single test session.
In the third phase, participants will be randomized to either a control 4-week exercise intervention (conventional physical therapy) or a 4-week experimental exercise intervention (plantar flexion training). Both the control and exerimental arms will complete over-ground multi-directional gait training and home exercise.
- Conditions
- Stroke, Hemiplegic Gait
- Being tested
- Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Control 4-week exercise intervention
- Keywords
- stroke rehabilitation, walking limitations, gait rehabilitation
- Medical subject headings
- Stroke, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skateboard exercise at an incline angle of 0 degrees and 50% body weightOther
Participants will stand on a specified incline angle (0 degrees) and with a specified body weight (50%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.
Skateboard exercise at an incline angle of 5 degrees and 50% body weightOther
Participants will stand on a specified incline angle (5 degrees) and with a specified body weight (50%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.
Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weightOther
Participants will stand on a specified incline angle (either 0 or 5 degrees, whichever is determined during phase 1 to be optimal) and with a specified body weight (75%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.
Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weightOther
Participants will stand on a specified incline angle (either 0 or 5 degrees, whichever is determined during phase 1 to be optimal) and with a specified body weight (90%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.
Control 4-week exercise interventionOther
Also called conventional physical therapy
This intervention occurs in phase 3. Subjects will participate in 1-hour sessions three times per week for four weeks. The control group will perform three sets of ten repetitions of the following 4 exercises, for a total of 120 repetitions: 1) standing hip abduction against green theraband resistance with upper extremity support, 2) sit to stands from chair with no upper extremity support, 3) bilateral calf raises with upper extremity support, and 4) right and left weight shifting exercises using a wobble board with upper extremity support available if needed.
Experimental 4-week exercise interventionOther
Also called Plantar flexion training
This intervention occurs in phase 3. Subjects will participate in 1-hour sessions three times per week for four weeks. The experimental group will perform the skateboard exercise with the optimal parameters established during studies 1 and 2 (that is, an incline angle of either 0 or 5 degrees and a body weight percentage of 50%, 75%, or 90%)--the forward and backward speed of the skateboard will be cued with a metronome that will set at a beats per minute that matches the foot strike cadence of someone walking at 0.7 m/s, and the magnitude of forward excursion of the skateboard will be individualized to the participant based on GAITRite® data (that is, step length of the non-paretic LE).
Over-ground multi-directional gait trainingOther
In the over-ground multi-directional gait protocol, the participant will walk 750 steps forward, 50 steps backward, and 200 side steps over level surfaces. The over ground gait training will focus on equalizing step length while performing multi-directional gait training.
Home exerciseOther
Home exercise consists of three sets of ten repetitions of the following three exercises to be performed on non-therapy days over the four weeks of phase 3: 1) sit to stands from chair with no upper extremity support, 2) bilateral calf raises with hand support, and 3) resisted side stepping to the non-paretic side using a green theraband with upper extremity support.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (control 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 2 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (control 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 3 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (control 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 4 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (control 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 5 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (control 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 6 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (control 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 7 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (control 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 8 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (control 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 9 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (control 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 10 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (control 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 11 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (control 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 12 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (control 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Control 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 13 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (experimental 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 14 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (experimental 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 15 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (experimental 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 16 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (experimental 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 17 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (experimental 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 18 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (experimental 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 19 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (experimental 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 20 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (experimental 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 21 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (experimental 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 22 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (experimental 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 23 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (experimental 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
| 24 | Experimental | Phase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (experimental 4-week exercise intervention) Receives: Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight; Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight; Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight; Other: Experimental 4-week exercise intervention; Other: Over-ground multi-directional gait training; Other: Home exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step length asymmetry ratio as assessed by the GAITRite®
The step length asymmetry ratio will be calculated by dividing the paretic step length by non-paretic step lengths. The magnitude of the ratio indicates the nature of the asymmetry, with symmetrical gait defined as step length ratio of 0.9-1.1, and asymmetrical gait where the non-paretic step lengths are longer than the paretic step lengths with any step length ratio greater than 1.1.
Measured: baseline, 6 weeks (relative to the phase 3 intervention)
Muscle activity of the medial gastrocnemius as assessed by surface EMG
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).
Measured: on the 1 day of the phase 1 intervention
Muscle activity of the soleus as assessed by surface EMG
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).
Measured: on the 1 day of the phase 1 intervention
Plantar flexion torque as assessed by isokinetic dynamometry
Peak plantar flexion torque will be acquired using an isokinetic dynamometer(Biodex Medical Systems, Shirely, New York, USA). Calibration of the Biodex® will be performed prior to the assessment of each individual. For each participant, the plantar flexors will be warmed-up on a LE ergometer for 10 minutes prior to testing. The participant will be fully secured to prevent compensatory behaviors from trunk or hips that may influence results. A pre-speed warm up on the Biodex of three submaximal repetitions and one maximal repetition will be conducted prior to testing so the participant understands what these repetitions feel like. The angular velocity will be set a 60°/second, five repetitions will be performed, and the peak torque of the plantar flexors will be collected.
Measured: baseline, 6 weeks (relative to the phase 3 intervention)
Muscle activity of the medial gastrocnemius as assessed by surface EMG
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).
Measured: on the 1 day of the phase 2 intervention
Muscle activity of the soleus as assessed by surface EMG
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).
Measured: on the 1 day of the phase 2 intervention
Secondary outcomes (4)
Gait speed as assessed by the GAITRite®
Self-selected gait speed will be acquired using the GAITRite®.
Measured: baseline, 6 weeks (relative to the phase 3 intervention)
Muscle activity of the medial gastrocnemius as assessed by surface EMG
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).
Measured: baseline, 6 weeks (relative to the phase 3 intervention)
Muscle activity of the soleus as assessed by surface EMG
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).
Measured: baseline, 6 weeks (relative to the phase 3 intervention)
Quality of life as assessed by the Stroke Impact Scale
The physical domain of the Stroke Impact Scale will used to determine quality of life. The Stroke Impact Scale is a self-report measure designed to capture eight domains of health status. The physical domain has nine items that are rated using a 5 point Likert scale in terms of how difficult certain physical tasks are. The domains are scored separately using a transformed scale formula: [(raw score - lowest possible raw score) / highest possible raw score] x 100. A composite score will be assessed.
Measured: baseline, 6 weeks (relative to the phase 3 intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start1 Oct 2018
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Woman's University
- Responsible party
- Principal investigator, Daniel Wingard, The University of Texas Health Science Center, Houston
- Investigators
- Daniel P Wingard, DPT, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548090
- Sponsor's protocol ID
- HSC-MH-17-0284
- Status last verified
- Sep 2021
- First submitted
- 24 May 2018
- Last updated
- 1 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Plantar Flexion Training on Plantar Flexion Activation, Torque, and Step Length Asymmetry in People With Chronic Stroke
- ClinicalTrials.gov ID
- NCT03548090
- Acronym / sponsor ID
- HSC-MH-17-0284
- Conditions
- Stroke, Hemiplegic Gait
- Keywords
- stroke rehabilitation, walking limitations, gait rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Texas Woman's University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 7 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study consists of three phases that aim to develop an exercise intervention to promote maximal activation of ankle plantar flexors in the paretic lower extrimty (LE) in order to restore a more normalized gait pattern in chronic stroke survivors.
The aim of the first phase is to determine if there are differences between standing on different levels of inclination on plantar flexion activation during forward movement of the contralateral LE in adults with chronic with stroke.
The aim of second phase is to determine if there are differences between different percentages of weight bearing on the paretic LE on plantar flexion activation during forward movement of the contralateral LE in adults with chronic stroke.
The aim of the third phase is to determine if there are differences between a 4-week plantar flexion training intervention and conventional physical therapy.
Detailed description
Description of Arms:
This study has three phases. The first phase is performed in a cross-over fashion. Participants will stand on two different incline angles on the paretic LE and simultaneously move a small skateboard forward with the non-paretic LE. The testing order for the two different incline angles will be randomized, and all participants will be required to complete both incline angle conditions within a single test session.
The second phase will also be performed in a cross-over fashion. Participants will stand with three different percentages of body weight on their paretic LE while moving the skateboard forward with the non-paretic LE. The testing order for the three body weight percentages will be randomized. All participants will be required to complete all three body weight conditions within a single test session.
In the third phase, participants will be randomized to either a control 4-week exercise intervention (conventional physical therapy) or a 4-week experimental exercise intervention (plantar flexion training). Both the control and exerimental arms will complete over-ground multi-directional gait training and home exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 24
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Control 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (control 4-week exercise intervention) |
| 2 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Control 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (control 4-week exercise intervention) |
| 3 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Control 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (control 4-week exercise intervention) |
| 4 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Control 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (control 4-week exercise intervention) |
| 5 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Control 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (control 4-week exercise intervention) |
| 6 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Control 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (control 4-week exercise intervention) |
| 7 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Control 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (control 4-week exercise intervention) |
| 8 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Control 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (control 4-week exercise intervention) |
| 9 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Control 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (control 4-week exercise intervention) |
| 10 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Control 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (control 4-week exercise intervention) |
| 11 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Control 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (control 4-week exercise intervention) |
| 12 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Control 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (control 4-week exercise intervention) |
| 13 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Experimental 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (experimental 4-week exercise intervention) |
| 14 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Experimental 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (experimental 4-week exercise intervention) |
| 15 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Experimental 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (experimental 4-week exercise intervention) |
| 16 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Experimental 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (experimental 4-week exercise intervention) |
| 17 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Experimental 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (experimental 4-week exercise intervention) |
| 18 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Experimental 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 0 degrees, then 5 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (experimental 4-week exercise intervention) |
| 19 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Experimental 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 75%, then 90%), Phase 3 (experimental 4-week exercise intervention) |
| 20 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Experimental 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 50%, then 90%, then 75%), Phase 3 (experimental 4-week exercise intervention) |
| 21 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Experimental 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 50%, then 90%), Phase 3 (experimental 4-week exercise intervention) |
| 22 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Experimental 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 75%, then 90%, then 50%), Phase 3 (experimental 4-week exercise intervention) |
| 23 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Experimental 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 50%, then 75%), Phase 3 (experimental 4-week exercise intervention) |
| 24 | Experimental | Other: Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Other: Skateboard exercise at an incline angle of 5 degrees and 50% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight, Other: Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight, Other: Experimental 4-week exercise intervention, Other: Over-ground multi-directional gait training, Other: Home exercisePhase 1 (skateboard exercise at 50% body weight and an incline level of 5 degrees, then 0 degrees), Phase 2 (skateboard exercise with incline level determined to be optimal in phase 1 and body weight at 90%, then 75%, then 50%), Phase 3 (experimental 4-week exercise intervention) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be able to perform five times sit to stand test without the use of upper extremities
- Must have 10 degrees of passive ankle dorsiflexion measured in standing
- Must be able to walk with supervision level assistance with no assistive device
Key exclusion criteria (9 listed)
- Currently receiving physical therapy
- History of orthopedic ankle instability
- Lacking knee extension to neutral
- Unable to understand English
- Unable to follow multi-step commands
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skateboard exercise at an incline angle of 0 degrees and 50% body weightParticipants will stand on a specified incline angle (0 degrees) and with a specified body weight (50%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE. | Other | 1, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 2, 20, 21, 22, 23, 24, 3, 4, 5, 6, 7, 8, 9 |
| Skateboard exercise at an incline angle of 5 degrees and 50% body weightParticipants will stand on a specified incline angle (5 degrees) and with a specified body weight (50%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE. | Other | 1, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 2, 20, 21, 22, 23, 24, 3, 4, 5, 6, 7, 8, 9 |
| Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weightParticipants will stand on a specified incline angle (either 0 or 5 degrees, whichever is determined during phase 1 to be optimal) and with a specified body weight (75%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE. | Other | 1, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 2, 20, 21, 22, 23, 24, 3, 4, 5, 6, 7, 8, 9 |
| Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weightParticipants will stand on a specified incline angle (either 0 or 5 degrees, whichever is determined during phase 1 to be optimal) and with a specified body weight (90%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE. | Other | 1, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 2, 20, 21, 22, 23, 24, 3, 4, 5, 6, 7, 8, 9 |
| Control 4-week exercise interventionAlso: conventional physical therapyThis intervention occurs in phase 3. Subjects will participate in 1-hour sessions three times per week for four weeks. The control group will perform three sets of ten repetitions of the following 4 exercises, for a total of 120 repetitions: 1) standing hip abduction against green theraband resistance with upper extremity support, 2) sit to stands from chair with no upper extremity support, 3) bilateral calf raises with upper extremity support, and 4) right and left weight shifting exercises using a wobble board with upper extremity support available if needed. | Other | 1, 10, 11, 12, 2, 3, 4, 5, 6, 7, 8, 9 |
| Experimental 4-week exercise interventionAlso: Plantar flexion trainingThis intervention occurs in phase 3. Subjects will participate in 1-hour sessions three times per week for four weeks. The experimental group will perform the skateboard exercise with the optimal parameters established during studies 1 and 2 (that is, an incline angle of either 0 or 5 degrees and a body weight percentage of 50%, 75%, or 90%)--the forward and backward speed of the skateboard will be cued with a metronome that will set at a beats per minute that matches the foot strike cadence of someone walking at 0.7 m/s, and the magnitude of forward excursion of the skateboard will be individualized to the participant based on GAITRite® data (that is, step length of the non-paretic LE). | Other | 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24 |
| Over-ground multi-directional gait trainingIn the over-ground multi-directional gait protocol, the participant will walk 750 steps forward, 50 steps backward, and 200 side steps over level surfaces. The over ground gait training will focus on equalizing step length while performing multi-directional gait training. | Other | 1, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 2, 20, 21, 22, 23, 24, 3, 4, 5, 6, 7, 8, 9 |
| Home exerciseHome exercise consists of three sets of ten repetitions of the following three exercises to be performed on non-therapy days over the four weeks of phase 3: 1) sit to stands from chair with no upper extremity support, 2) bilateral calf raises with hand support, and 3) resisted side stepping to the non-paretic side using a green theraband with upper extremity support. | Other | 1, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 2, 20, 21, 22, 23, 24, 3, 4, 5, 6, 7, 8, 9 |
Primary outcome
Step length asymmetry ratio as assessed by the GAITRite®
Time frame: baseline, 6 weeks (relative to the phase 3 intervention)
The step length asymmetry ratio will be calculated by dividing the paretic step length by non-paretic step lengths. The magnitude of the ratio indicates the nature of the asymmetry, with symmetrical gait defined as step length ratio of 0.9-1.1, and asymmetrical gait where the non-paretic step lengths are longer than the paretic step lengths with any step length ratio greater than 1.1.
Muscle activity of the medial gastrocnemius as assessed by surface EMG
Time frame: on the 1 day of the phase 1 intervention
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).
Muscle activity of the soleus as assessed by surface EMG
Time frame: on the 1 day of the phase 1 intervention
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).
Plantar flexion torque as assessed by isokinetic dynamometry
Time frame: baseline, 6 weeks (relative to the phase 3 intervention)
Peak plantar flexion torque will be acquired using an isokinetic dynamometer(Biodex Medical Systems, Shirely, New York, USA). Calibration of the Biodex® will be performed prior to the assessment of each individual. For each participant, the plantar flexors will be warmed-up on a LE ergometer for 10 minutes prior to testing. The participant will be fully secured to prevent compensatory behaviors from trunk or hips that may influence results. A pre-speed warm up on the Biodex of three submaximal repetitions and one maximal repetition will be conducted prior to testing so the participant understands what these repetitions feel like. The angular velocity will be set a 60°/second, five repetitions will be performed, and the peak torque of the plantar flexors will be collected.
Muscle activity of the medial gastrocnemius as assessed by surface EMG
Time frame: on the 1 day of the phase 2 intervention
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of medial gastrocnemius muscle in the paretic lower extremity (LE).
Muscle activity of the soleus as assessed by surface EMG
Time frame: on the 1 day of the phase 2 intervention
Muscle activity of the medial gastrocnemius will be assessed using surface EMG (Delsys Trigno EMG system, Boston, MA, USA). The EMG instrument will be placed on the muscle belly of soleus muscle in the paretic lower extremity (LE).
4 secondary outcomes
Gait speed as assessed by the GAITRite®
Time frame: baseline, 6 weeks (relative to the phase 3 intervention)
Muscle activity of the medial gastrocnemius as assessed by surface EMG
Time frame: baseline, 6 weeks (relative to the phase 3 intervention)
Muscle activity of the soleus as assessed by surface EMG
Time frame: baseline, 6 weeks (relative to the phase 3 intervention)
Quality of life as assessed by the Stroke Impact Scale
Time frame: baseline, 6 weeks (relative to the phase 3 intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel P Wingard, DPT principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skateboard exercise at an incline angle of 0 degrees and 50% body weight, Skateboard exercise at an incline angle of 5 degrees and 50% body weight and Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight in people with Stroke and Hemiplegic Gait, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step length asymmetry ratio as assessed by the GAITRite® (time frame: baseline, 6 weeks (relative to the phase 3 intervention)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.