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RecruitingNCT03264261Updated Jun 3, 2025

Constraint Induced Movement Therapy for Walking in Individuals Post Stroke

An interventional study of robotic training and treadmill training in Stroke, sponsored by Shirley Ryan AbilityLab. Recruiting at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-03.

Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
21 Years to 75 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Stroke

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Keywords

  • stroke, locomotion
03

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. age between 21 and 75 years;
  2. history of unilateral, supratentorial, ischemic or hemorrhagic stroke;
  3. no prior stroke;
  4. demonstration of impaired walking function (self-selected walking speed ≤ 0.80 m/s);
  5. able to stand and walk (>10 meters) without physical assistance.

Exclusion criteria

Exclusion Criteria:

  1. significant cardiorespiratory/metabolic disease;
  2. other neurological or orthopedic injury that impairs locomotion;
  3. scores on the Mini Mental Status examination \< 24;
  4. stroke of the brainstem or cerebellar lesions;
  5. uncontrolled hypertension (systolic > 200 mm Hg, diastolic > 110 mm Hg);
  6. botox injection within 6 months of starting the study.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (estimated)

Study arms

  • Experimental
    robotic training

    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.

    Device: robotic training

  • Active comparator
    treadmill training

    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.

    Device: treadmill training

Interventions

  • Devicerobotic training

    robotic training, 3 times/week for 6 weeks

  • Devicetreadmill training

    treadmill training only, 3 times/week for 6 weeks

05

What researchers measure

Primary outcomes

  1. Change in walking speed

    Overground gait speed will be collected on a 10 m instrumented walkway

    Time frame: pre, post 6 weeks training, and 8 weeks after the end of training.

  2. Change in 6-minute walking distance

    walking distance covered by subjects in 6 minutes

    Time frame: 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

    Time frame: pre, post 6 weeks training, and 8 weeks after the end of training.

06

Study locations

1 of 1 sites recruiting
  • Abilitylab
    Chicago, Illinois 60611, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03264261
Lead sponsor
Shirley Ryan AbilityLab
Responsible party
Ming Wu (Research Scientist, Shirley Ryan AbilityLab) — Principal investigator
First posted
Aug 29, 2017
Start date
Aug 14, 2017
Primary completion
Jul 30, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Jun 3, 2025

Study contacts

Weena Dee, PT
Contact
wdee@ric.org
312-238-7503
Ming Wu, PhD
principal investigator · Abilitylab

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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