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NCT Number: NCT03264261

Constraint Induced Movement Therapy for Walking in Individuals Post Stroke

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.

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Key information

Age range

21 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Abilitylab

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Weena Dee, PT

CONTACT

[email protected]

312-238-7503

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Robotic Training

Device

robotic training, 3 times/week for 6 weeks

treadmill training

Device

treadmill training only, 3 times/week for 6 weeks

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Change in Berg Balance Scale

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

    Berg Balance Scale scores will be collected by research physical therapist

Study contacts

Contact information is provided by the study sponsor or research team.

Weena Dee, PT

CONTACT

[email protected]

312-238-7503

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Aug 29, 2017
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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