Muscular WeaknessNCT03670563
Training Intrinsic Foot Muscles
A study testing Short foot exercise protocol and Short foot exercise plus NMES in people with Muscular Weakness, run by St. Louis University at 1 site in United States.
Trial summary
The foot intrinsic muscles are increasingly targeted in foot and ankle rehabilitation. The exercises are often difficult to learn initially. The purpose of the proposed study is to examine the effect training the intrinsic foot muscles on performance in selected physical and functional measures such as balance… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscular Weakness
- What is being tested?
- Short foot exercise protocol and Short foot exercise plus NMES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2018to 5 Apr 2019
- 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals aged 18-30; Participate in physical activity 3 times/week; No neurologic injury/condition; No prior experience with study exercises; No injury to lower extremity in past 2 months; Inability to selectively extend the great toe while the lesser toes remain quiet (indicating INTRINSIC FOOT MUSCLES dysfunction)
Who cannot join
- Sedentary; Known neurologic injury or condition; Current LE injury that may affect neuromuscular function; Tarsal coalition; Absolute contradiction to manual therapy or neuromuscular electrical stimulation (NMES); Previous intrinsic foot muscle training protocol
Trial locations and contacts
1 site in 1 country.
About this study
The foot intrinsic muscles are increasingly targeted in foot and ankle rehabilitation. The exercises are often difficult to learn initially. The purpose of the proposed study is to examine the effect training the intrinsic foot muscles on performance in selected physical and functional measures such as balance, plantar pressure during gait, vertical jump, and foot posture. In addition,the investigators will compare one group training with traditional exercise instruction methods and one group using an adjunctive modality (neuromuscular electric stimulation) during the introductory phases of exercise instruction. The investigators are interested in how this modality might affect physical and functional outcome measures and if it affects participants' frustration with learning a new exercise.
Read the detailed description
Arm 1: The purpose of this arm of the study is to determine if a 4-week trial of foot muscle exercises, instructed with passive, active-assisted, and active techniques, affect functional measures such as balance, plantar pressure during gait, and vertical jump. A frustration index will be employed to assess participant frustration with learning a new exercise. 15 will be enrolled in this arm of the study.
Arm 2: The purpose of this arm of the study is to determine if a 4-week trial of foot muscle exercises, instructed with neuromuscular electric stimulation (NMES) and active techniques, affect functional measures such as balance, plantar pressure during gait, and vertical jump. A frustration index will be employed to assess participant frustration with learning a new exercise.15 will be enrolled in this arm of the study.
Arm 3: This group will not engage in any training, but will serve as a comparator for the two intervention arms.
- Conditions
- Muscular Weakness
- Being tested
- Short foot exercise protocol, Short foot exercise plus NMES
- Keywords
- Therapeutic exercise
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short foot exercise protocolOther
Exercises that target intrinsic foot muscles
Short foot exercise plus NMESOther
Exercises that target intrinsic foot muscles supplemented by NMES for muscle re-education
| Study group | Role | What they receive |
|---|---|---|
| Exercise 1 | Experimental | Short foot exercise protocol instructed utilizing verbal instruction, passive modeling, active-assisted modeling, and active modeling. Receives: Other: Short foot exercise protocol |
| Exercise 2 | Active comparator | Short foot exercises plus NMES. Short foot exercise protocol instructed utilizing verbal instruction, passive modeling assisted by neuromuscular electric stimulation (NMES), active-assisted modeling assisted by neuromuscular electric stimulation, and active modeling. Receives: Other: Short foot exercise plus NMES |
| Control | No intervention | No exercise intervention; continue normal physical activity, but do not start any new exercise programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaching Distance
The change demonstrated in clinical test of single limb reach/balance in the anterior, posterolateral, and posteriomedial directions in cm
Measured: Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Center of pressure during walking gait
Changes in center of pressure during walking gait
Measured: Arm 1 and Arm 2: Baseline, 2 wk, 4 wk, 8 wk. Arm 3: Baseline 4 wk, 8 wk
Secondary outcomes (5)
Changes in foot posture over loading conditions
Change in navicular height from 10% weight bearing to 90% weight bearing in mm
Measured: Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Arch Height Index
Change in arch height from 10% weight bearing to 90% weight bearing relative to truncated foot length (in %)
Measured: Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Maximal vertical jump height
Maximal height jump off of two feet will be measured in centimeters
Measured: Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Changes in landing forces
Change in vertical ground reaction force during landing after vertical jump
Measured: Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Perceived effort in learning novel exercise measured by NASA-Task Load Index (NASA-TLX)
Participant reported workload estimates of Mental, Physical, and Temporal Demands, Frustration, Effort, and Performance. RAW TLX will be utilized, with each component considered individually; the subscales will not be combined. Subscales are rated 0-21; higher scores indicate greater load or difficulty
Measured: Arm 1 and Arm 2: Supervised training sessions 1, 2, 3, 4, 5, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start10 Oct 2018
- Primary completion5 Apr 2019
- Study completion5 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscular WeaknessStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- Randomized controlled trial with two intervention arms and one control arm
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Newsham PhD, ATC, St. Louis University
- Investigators
- Katherine Newsham, PhD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670563
- Sponsor's protocol ID
- IRB# 29267
- Status last verified
- May 2019
- First submitted
- 11 Sep 2018
- Last updated
- 3 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Intrinsic Foot Muscles
- ClinicalTrials.gov ID
- NCT03670563
- Acronym / sponsor ID
- IRB# 29267
- Conditions
- Muscular Weakness
- Keywords
- Therapeutic exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 5 Apr 2019 (actual)
- Study completion
- 5 Apr 2019 (actual)
- First posted
- 13 Sep 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.
The foot intrinsic muscles are increasingly targeted in foot and ankle rehabilitation. The exercises are often difficult to learn initially. The purpose of the proposed study is to examine the effect training the intrinsic foot muscles on performance in selected physical and functional measures such as balance, plantar pressure during gait, vertical jump, and foot posture. In addition,the investigators will compare one group training with traditional exercise instruction methods and one group using an adjunctive modality (neuromuscular electric stimulation) during the introductory phases of exercise instruction. The investigators are interested in how this modality might affect physical and functional outcome measures and if it affects participants' frustration with learning a new exercise.
Detailed description
Arm 1: The purpose of this arm of the study is to determine if a 4-week trial of foot muscle exercises, instructed with passive, active-assisted, and active techniques, affect functional measures such as balance, plantar pressure during gait, and vertical jump. A frustration index will be employed to assess participant frustration with learning a new exercise. 15 will be enrolled in this arm of the study.
Arm 2: The purpose of this arm of the study is to determine if a 4-week trial of foot muscle exercises, instructed with neuromuscular electric stimulation (NMES) and active techniques, affect functional measures such as balance, plantar pressure during gait, and vertical jump. A frustration index will be employed to assess participant frustration with learning a new exercise.15 will be enrolled in this arm of the study.
Arm 3: This group will not engage in any training, but will serve as a comparator for the two intervention arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial with two intervention arms and one control arm
| Arm | Type | Receives |
|---|---|---|
| Exercise 1 | Experimental | Other: Short foot exercise protocolShort foot exercise protocol instructed utilizing verbal instruction, passive modeling, active-assisted modeling, and active modeling. |
| Exercise 2 | Active comparator | Other: Short foot exercise plus NMESShort foot exercises plus NMES. Short foot exercise protocol instructed utilizing verbal instruction, passive modeling assisted by neuromuscular electric stimulation (NMES), active-assisted modeling assisted by neuromuscular electric stimulation, and active modeling. |
| Control | No intervention | –No exercise intervention; continue normal physical activity, but do not start any new exercise programs |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals aged 18-30; Participate in physical activity 3 times/week; No neurologic injury/condition; No prior experience with study exercises; No injury to lower extremity in past 2 months; Inability to selectively extend the great toe while the lesser toes remain quiet (indicating INTRINSIC FOOT MUSCLES dysfunction)
Key exclusion criteria (1 listed)
- Sedentary; Known neurologic injury or condition; Current LE injury that may affect neuromuscular function; Tarsal coalition; Absolute contradiction to manual therapy or neuromuscular electrical stimulation (NMES); Previous intrinsic foot muscle training protocol
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 |
|---|---|---|
| Short foot exercise protocolExercises that target intrinsic foot muscles | Other | Exercise 1 |
| Short foot exercise plus NMESExercises that target intrinsic foot muscles supplemented by NMES for muscle re-education | Other | Exercise 2 |
Primary outcome
Reaching Distance
Time frame: Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
The change demonstrated in clinical test of single limb reach/balance in the anterior, posterolateral, and posteriomedial directions in cm
Center of pressure during walking gait
Time frame: Arm 1 and Arm 2: Baseline, 2 wk, 4 wk, 8 wk. Arm 3: Baseline 4 wk, 8 wk
Changes in center of pressure during walking gait
5 secondary outcomes
Changes in foot posture over loading conditions
Time frame: Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Arch Height Index
Time frame: Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Maximal vertical jump height
Time frame: Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Changes in landing forces
Time frame: Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks
Perceived effort in learning novel exercise measured by NASA-Task Load Index (NASA-TLX)
Time frame: Arm 1 and Arm 2: Supervised training sessions 1, 2, 3, 4, 5, and 6
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 3 May 2019.
- Individual participant dataSharing planned: No
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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.
Katherine Newsham, PhD principal investigator
St. Louis University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short foot exercise protocol and Short foot exercise plus NMES in people with Muscular Weakness, run by St. Louis University 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 1 inclusion and 1 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 3 May 2019. 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?
Reaching Distance (time frame: Arm 1 and Arm 2: Baseline, 2 weeks, 4 weeks, 8 weeks. Arm 3: Baseline 4 weeks, 8 weeks). The study lists 2 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 3 May 2019.