Clinical trial NCT03264261: Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
Official title: Constraint Induced Movement Therapy for Walking in Individuals Post Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: stroke, locomotion
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
First posted: 2017-08-29
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

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.

Primary outcomes:
measure: Change in walking speed
timeFrame: pre, post 6 weeks training, and 8 weeks after the end of training.
measure: Change in 6-minute walking distance
timeFrame: pre, post 6 weeks training, and 8 weeks after the end of training.
Secondary outcomes:
measure: Change in Berg Balance Scale
timeFrame: pre, post 6 weeks training, and 8 weeks after the end of training.
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Abilitylab
state: Illinois
Study officials:
affiliation: Abilitylab
name: Ming Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References: