StrokeNCT03264261
Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
A study testing robotic training and treadmill training in people with Stroke, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial summary
To compare the effect of constraint induced movement therapy (CIMT) vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- robotic training and treadmill training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Aug 2017to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 21 and 75 years;
- history of unilateral, supratentorial, ischemic or hemorrhagic stroke;
- no prior stroke;
- demonstration of impaired walking function (self-selected walking speed ≤ 0.80 m/s);
- able to stand and walk (>10 meters) without physical assistance.
Who cannot join
- significant cardiorespiratory/metabolic disease;
- other neurological or orthopedic injury that impairs locomotion;
- scores on the Mini Mental Status examination < 24;
- stroke of the brainstem or cerebellar lesions;
- uncontrolled hypertension (systolic > 200 mm Hg, diastolic > 110 mm Hg);
- botox injection within 6 months of starting the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abilitylab
Chicago, Illinois, 60611
Weena Dee, PT, 312-238-7503, wdee@sralab.org
About this study
To compare the effect of constraint induced movement therapy (CIMT) vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. Subjects will be randomized to either the CIMT or treadmill training only groups at the initial test. Following the initial test, individuals from the 2 groups will undergo intensive locomotor training. Training will be performed 3 times per week for 6 weeks with the training time for each visit set to 45 minutes as tolerated. Data collection will proceed until 36 subjects from 2 groups have been trained.
Read the detailed description
To determine the effect of constraint induced movement therapy (CIMT) on locomotor function in individuals post stroke. In order to compare the effect of CIMT vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. Subjects will be blocked by gait speed into slow (< 0.4 m/s) or fast (≥ 0.4 m/s) subgroups and randomized to either the CIMT or treadmill training only groups at the initial test. Following the initial test, individuals from the 2 groups will undergo intensive locomotor training. Training will be performed 3 times per week for 6 weeks with the training time for each visit set to 45 minutes as tolerated, excluding set up time. Data collection will proceed until 36 subjects from 2 groups have been trained.
- Conditions
- Stroke
- Being tested
- robotic training, treadmill training
- Keywords
- stroke, locomotion
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic trainingDevice
robotic training, 3 times/week for 6 weeks
treadmill trainingDevice
treadmill training only, 3 times/week for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| robotic training | Experimental | For the robotic training group, a controlled resistance load will be applied to the unaffected leg at the ankle and an assistance load will be applied to the pelvis. Receives: Device: robotic training |
| treadmill training | Active comparator | For the treadmill training only group, a physical therapist will provide manual assistance to the affected leg at the knee and/or ankle joints as necessary during treadmill training. Receives: Device: treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in walking speed
Overground gait speed will be collected on a 10 m instrumented walkway
Measured: pre, post 6 weeks training, and 8 weeks after the end of training.
Change in 6-minute walking distance
walking distance covered by subjects in 6 minutes
Measured: pre, post 6 weeks training, and 8 weeks after the end of training.
Secondary outcomes (1)
Change in Berg Balance Scale
Berg Balance Scale scores will be collected by research physical therapist
Measured: pre, post 6 weeks training, and 8 weeks after the end of training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start14 Aug 2017
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
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.
- 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
- Subjects will be blocked by gait speed into slow (\< 0.4 m/s) or fast (≥ 0.4 m/s) subgroups and randomized to either the CIMT or treadmill training only groups at the initial test.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming Wu, Shirley Ryan AbilityLab
- Investigators
- Ming Wu, PhD, Principal investigator, Abilitylab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264261
- Sponsor's protocol ID
- R01HD082216
- Status last verified
- May 2025
- First submitted
- 14 Aug 2017
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
- ClinicalTrials.gov ID
- NCT03264261
- Acronym / sponsor ID
- R01HD082216
- Conditions
- Stroke
- Keywords
- stroke, locomotion
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 14 Aug 2017 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 29 Aug 2017 (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.
To compare the effect of constraint induced movement therapy (CIMT) vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. Subjects will be randomized to either the CIMT or treadmill training only groups at the initial test. Following the initial test, individuals from the 2 groups will undergo intensive locomotor training. Training will be performed 3 times per week for 6 weeks with the training time for each visit set to 45 minutes as tolerated. Data collection will proceed until 36 subjects from 2 groups have been trained.
Detailed description
To determine the effect of constraint induced movement therapy (CIMT) on locomotor function in individuals post stroke. In order to compare the effect of CIMT vs. treadmill training only on walking function in individuals post-stroke, a 6 week, single-blind, randomized training study will be conducted with three assessments of gait to determine the training effect. Subjects will be blocked by gait speed into slow (< 0.4 m/s) or fast (≥ 0.4 m/s) subgroups and randomized to either the CIMT or treadmill training only groups at the initial test. Following the initial test, individuals from the 2 groups will undergo intensive locomotor training. Training will be performed 3 times per week for 6 weeks with the training time for each visit set to 45 minutes as tolerated, excluding set up time. Data collection will proceed until 36 subjects from 2 groups have been trained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be blocked by gait speed into slow (< 0.4 m/s) or fast (≥ 0.4 m/s) subgroups and randomized to either the CIMT or treadmill training only groups at the initial test.
| Arm | Type | Receives |
|---|---|---|
| robotic training | Experimental | Device: robotic trainingFor the robotic training group, a controlled resistance load will be applied to the unaffected leg at the ankle and an assistance load will be applied to the pelvis. |
| treadmill training | Active comparator | Device: treadmill trainingFor the treadmill training only group, a physical therapist will provide manual assistance to the affected leg at the knee and/or ankle joints as necessary during treadmill training. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age between 21 and 75 years;
- history of unilateral, supratentorial, ischemic or hemorrhagic stroke;
- no prior stroke;
- demonstration of impaired walking function (self-selected walking speed ≤ 0.80 m/s);
- able to stand and walk (>10 meters) without physical assistance.
Key exclusion criteria (6 listed)
- significant cardiorespiratory/metabolic disease;
- other neurological or orthopedic injury that impairs locomotion;
- scores on the Mini Mental Status examination < 24;
- stroke of the brainstem or cerebellar lesions;
- uncontrolled hypertension (systolic > 200 mm Hg, diastolic > 110 mm Hg);
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 |
|---|---|---|
| robotic trainingrobotic training, 3 times/week for 6 weeks | Device | robotic training |
| treadmill trainingtreadmill training only, 3 times/week for 6 weeks | Device | treadmill training |
Primary outcome
Change in walking speed
Time frame: pre, post 6 weeks training, and 8 weeks after the end of training.
Overground gait speed will be collected on a 10 m instrumented walkway
Change in 6-minute walking distance
Time frame: pre, post 6 weeks training, and 8 weeks after the end of training.
walking distance covered by subjects in 6 minutes
1 secondary outcome
Change in Berg Balance Scale
Time frame: pre, post 6 weeks training, and 8 weeks after the end of training.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
- 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.
Ming Wu, PhD principal investigator
Abilitylab
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic training and treadmill training in people with Stroke, run by Shirley Ryan AbilityLab 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 5 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: looking for participants now, as of the sponsor's last update on 3 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weena Dee, PT (312-238-7503, wdee@ric.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in walking speed (time frame: pre, post 6 weeks training, and 8 weeks after the end of training.). 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 Jun 2025.