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Constraint Induced Movement Therapy for Walking in Individuals Post Stroke

ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-75
SponsorShirley Ryan AbilityLab

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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);

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • robotic training

    Device

    robotic training, 3 times/week for 6 weeks

  • treadmill training

    Device

    treadmill training only, 3 times/week for 6 weeks

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: robotic trainingExperimental treatment 1 intervention
Group B: treadmill trainingActive comparator 1 intervention

Trial outcomes

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shirley Ryan AbilityLab

Lead sponsor

Source ClinicalTrials.gov
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