StrokeNCT00712179
Understanding Different Parameters in Locomotor Training (a Type of Walking Training) for Person After a Stroke
An observational study of Stroke, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This is a research study to understand how people who have experienced a stroke walk in order to develop better and more effective types of therapy. Data collected from people who have experienced a stroke and healthy individuals will be used to compare a neurologically healthy person to someone, which has sustained… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Dec 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Controls and persons who have sustained a stroke
Who may be able to join
- adults at least 18 years old;
- able to provide informed consent;
- able to follow three-step motor command;
- have a single unilateral stroke;
- medically stable (i.e. asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, or other significant medical complications that would prohibit or interfere with walking;
- able to stand with assistance and/or ambulate 15 meters with or without an assistive device or brace and no greater than standby physical assistance.
Who cannot join
- weight > 300 pounds due to limitations in body weight support systems;
- body size which is incompatible with harnesses;
- pregnancy;
- presence of significant musculoskeletal problems that limit hip and knee extension or ankle plantarflexion to neutral;
- self selected walking speed below 0.3 m/s; and
- history of congestive cardiac failure, unstable angina, or peripheral vascular disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
About this study
Official title: Developing Evidence-based Parameter Selection for Locomotor Training
This is a research study to understand how people who have experienced a stroke walk in order to develop better and more effective types of therapy. Data collected from people who have experienced a stroke and healthy individuals will be used to compare a neurologically healthy person to someone, which has sustained an injury.
Read the detailed description
The first day will be a chance for the participants to become familiar with the body weight support (BWS) system and walking at different speeds. This first day will last about 2 hours and will consistent of fifteen total minutes of locomotor training utilizing manual trainers. This means trainers will move the participants'' body into a more normal walking pattern. The participants will be given a chance to rest between bouts; however, the participants may also rest at any point.
First, the participants will walk for five minutes at normal comfortable speed with 15% of the body weight supported through an overhead system. This will be followed by walking at speeds faster and slower than the participants' comfortable speed. After these initial bouts of stepping, will be the training bouts. Training will be conducted with 30% of the body weight supported and at speeds considered normal for adults. Trainers will assist the trunk and with each leg, and will assist with initiation of steps and leg positioning, maintenance of an upright trunk, pelvic rotation, and weight shift. Training will consist of three bouts of five minutes of stepping for a total duration of 15 minutes of stepping. Vital signs, heart rate and blood pressure, will be monitored after each 5-minute bout. If the participants wear an Ankle Foot Orthosis (AFO), the participants will be asked to walk without it, but the investigators will provide the participants with an Aircast, which supports the ankle and prevents it from rolling side to side, but allows the foot to move freely up and down ,
Data will be collected on the second day. This will take approximately five hours. During this time the participants will be asked to walk on the ground and on a treadmill. For the overground portion, the participants will walk across a 14-foot level, pressure-sensitive walkway at the participants' own speed and then as fast as the participants' can safely. This walkway measures the speed of walking and the size of steps. The participants can use any assistive device that the participants' typically use. A physical therapist or trained assistant will walk beside as the participants walk across the walkway. The participants will be asked to walk several times across the walkway at the two speeds while recordings are made from the participants' muscles and are videotaped.
The participants will also be asked to walk on a treadmill. The participants will be permitted to practice treadmill walking until the participants' feel comfortable. Once the participants feel comfortable the investigators will ask the participants to walk a couple different ways. The order will be random, and the speeds will be determined from the first visit. The participants will be asked to walk some with Body Weight Support and some without. The investigators will ask the participants to walk at the participants' comfortable speed and then as fast as the participants' can safely walk. The participants will also walk at these same speeds and percentage of body weight support while trainers help the participants step in a way as close to normal.
The participants will be able to rest at any point and for as long as they wish, however, after each trial the participants will be required to rest at least 2 minutes.
During all treadmill walking, the participants will wear a harness attached to a mobile device attached to the ceiling. This device is for safety to prevent a fall and it can catch the participants should they lose balance or stumble. It will also be used to provide body weight support for some of the walking trials. If the participants use braces and/or assistive devices, the participants will be asked to do some walking with and without them, according to the participants' comfort and safety. A therapist will walk with the participants to provide any physical assistance that may be needed.
For the walking testing, the investigators may need to shave small areas of the participants' legs to attach small sensors to the skin to measure the electrical activity of the leg muscles. The investigators will also attach reflective markers or small angle measurement devices to the skin over the participants' hips and several locations on the legs. The investigators will film the participants' movements with video cameras.
- Conditions
- Stroke
- Keywords
- Stroke, walking, Treadmill, body weight support system
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Stroke Survivors | Subjects walked with or with therapists' assistance at different speeds and different amounts of body weight support across conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic
The electromyographic (EMG) gait pattern of stroke survivors was compared with "normal" pattern using z-scores.
Measured: During sessions- 1 day measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionOct 2011
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Steve A. Kautz, PhD MS BS, Principal investigator, Ralph H. Johnson VA Medical Center, Charleston, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712179
- Sponsor's protocol ID
- A6365-R
- Status last verified
- Apr 2016
- First submitted
- 3 Jul 2008
- Last updated
- 13 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Srivastava S, Patten C, Kautz SA. Altered muscle activation patterns (AMAP): an analytical tool to compare muscle activity patterns of hemiparetic gait with a normative profile. J Neuroeng Rehabil. 2019 Jan 31;16(1):21. doi: 10.1186/s12984-019-0487-y.
PubMed 30704483
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Evidence-based Parameter Selection for Locomotor Training
- ClinicalTrials.gov ID
- NCT00712179
- Acronym / sponsor ID
- A6365-R
- Conditions
- Stroke
- Keywords
- Stroke, walking, Treadmill, body weight support system
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jul 2008
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Posted 13 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to understand how people who have experienced a stroke walk in order to develop better and more effective types of therapy. Data collected from people who have experienced a stroke and healthy individuals will be used to compare a neurologically healthy person to someone, which has sustained an injury.
Detailed description
The first day will be a chance for the participants to become familiar with the body weight support (BWS) system and walking at different speeds. This first day will last about 2 hours and will consistent of fifteen total minutes of locomotor training utilizing manual trainers. This means trainers will move the participants'' body into a more normal walking pattern. The participants will be given a chance to rest between bouts; however, the participants may also rest at any point.
First, the participants will walk for five minutes at normal comfortable speed with 15% of the body weight supported through an overhead system. This will be followed by walking at speeds faster and slower than the participants' comfortable speed. After these initial bouts of stepping, will be the training bouts. Training will be conducted with 30% of the body weight supported and at speeds considered normal for adults. Trainers will assist the trunk and with each leg, and will assist with initiation of steps and leg positioning, maintenance of an upright trunk, pelvic rotation, and weight shift. Training will consist of three bouts of five minutes of stepping for a total duration of 15 minutes of stepping. Vital signs, heart rate and blood pressure, will be monitored after each 5-minute bout. If the participants wear an Ankle Foot Orthosis (AFO), the participants will be asked to walk without it, but the investigators will provide the participants with an Aircast, which supports the ankle and prevents it from rolling side to side, but allows the foot to move freely up and down ,
Data will be collected on the second day. This will take approximately five hours. During this time the participants will be asked to walk on the ground and on a treadmill. For the overground portion, the participants will walk across a 14-foot level, pressure-sensitive walkway at the participants' own speed and then as fast as the participants' can safely. This walkway measures the speed of walking and the size of steps. The participants can use any assistive device that the participants' typically use. A physical therapist or trained assistant will walk beside as the participants walk across the walkway. The participants will be asked to walk several times across the walkway at the two speeds while recordings are made from the participants' muscles and are videotaped.
The participants will also be asked to walk on a treadmill. The participants will be permitted to practice treadmill walking until the participants' feel comfortable. Once the participants feel comfortable the investigators will ask the participants to walk a couple different ways. The order will be random, and the speeds will be determined from the first visit. The participants will be asked to walk some with Body Weight Support and some without. The investigators will ask the participants to walk at the participants' comfortable speed and then as fast as the participants' can safely walk. The participants will also walk at these same speeds and percentage of body weight support while trainers help the participants step in a way as close to normal.
The participants will be able to rest at any point and for as long as they wish, however, after each trial the participants will be required to rest at least 2 minutes.
During all treadmill walking, the participants will wear a harness attached to a mobile device attached to the ceiling. This device is for safety to prevent a fall and it can catch the participants should they lose balance or stumble. It will also be used to provide body weight support for some of the walking trials. If the participants use braces and/or assistive devices, the participants will be asked to do some walking with and without them, according to the participants' comfort and safety. A therapist will walk with the participants to provide any physical assistance that may be needed.
For the walking testing, the investigators may need to shave small areas of the participants' legs to attach small sensors to the skin to measure the electrical activity of the leg muscles. The investigators will also attach reflective markers or small angle measurement devices to the skin over the participants' hips and several locations on the legs. The investigators will film the participants' movements with video cameras.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke Survivors | – | –Subjects walked with or with therapists' assistance at different speeds and different amounts of body weight support across conditions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Controls and persons who have sustained a stroke
Key inclusion criteria (6 listed)
- adults at least 18 years old;
- able to provide informed consent;
- able to follow three-step motor command;
- have a single unilateral stroke;
- medically stable (i.e. asymptomatic for bladder infection, decubiti, osteoporosis, cardiopulmonary disease, pain, or other significant medical complications that would prohibit or interfere with walking;
Key exclusion criteria (6 listed)
- weight > 300 pounds due to limitations in body weight support systems;
- body size which is incompatible with harnesses;
- pregnancy;
- presence of significant musculoskeletal problems that limit hip and knee extension or ankle plantarflexion to neutral;
- self selected walking speed below 0.3 m/s; and
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic
Time frame: During sessions- 1 day measurement
The electromyographic (EMG) gait pattern of stroke survivors was compared with "normal" pattern using z-scores.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30704483Srivastava S, Patten C, Kautz SA. Altered muscle activation patterns (AMAP): an analytical tool to compare muscle activity patterns of hemiparetic gait with a normative profile. J Neuroeng Rehabil. 2019 Jan 31;16(1):21. doi: 10.1186/s12984-019-0487-y.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Steve A. Kautz, PhD MS BS principal investigator
Ralph H. Johnson VA Medical Center, Charleston, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by VA Office of Research and Development 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 6 inclusion and 6 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 13 May 2016. 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?
Yes. Results are posted in the registry (first posted 13 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diagnostic (time frame: During sessions- 1 day measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00712179, which also lists 1 linked publication.
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 13 May 2016.