Improving Ambulation Post Stroke With Robotic Training

Study Overview
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Brief Summary
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The purpose of this research study is to look at a new rehabilitation technique for individuals who have suffered a stroke and have difficulties walking. This study is designed to compare robot-assisted (Lokomat) rehabilitation therapy with standard physical therapy in order to improve walking post-stroke. This research project will be conducted as a pilot randomized controlled trial that compares the effectiveness of Lokomat versus conventional physical therapy in improving the ambulation and gait of chronic stroke patients. The project will provide important pilot data that could indicate whether or not the effectiveness of Lokomat training is superior to that of standard physical therapy and if a definitive and larger clinical trial is warranted.

Official Title
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Improving Ambulation Post Stroke With Robotic Training

Conditions
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Stroke

Intervention / Treatment
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* Other: Physical Therapy
* Device: Lokomat


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with ischemic or hemorrhagic stroke confirmed by cerebral computed tomography (CT) or magnetic resonance imaging (MRI) scan Age>18 At least 3 months post stroke at time of enrollment into study Ability to walk at least 10 feet with maximum 1 person assist, but not to walk in the community independently Residual paresis in the lower extremity as defined by the National Institute of Health Stroke Scale lower extremity motor score 2-4 Ability to perform Lokomat ambulation training with assistance of 1 therapist Ability to follow a three-step command Physician approval for patient participation Ability to give informed consent Completed their rehabilitation services, i.e., receiving no concurrent physical, occupational, or speech therapies Exclusion Criteria: Serious cardiac condition Uncontrolled blood pressure, defined as > 200 or diastolic > 100 at rest Hx of serious chronic obstructive pulmonary disease or oxygen dependence Sever weight bearing pain Lower extremity amputation Claudication while walking Life expectancy < 1 year History of deep vein thrombosis/pulmonary embolism (DVT/PE) within 6 months Severe orthopedic problem Any medical or psychiatric condition that the investigators believe would make the patient unable to participate in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lokomat Intervention<br>Lokomat gait training (five days a week for eight weeks for a total of 40 sessions). | Device: Lokomat<br>* Robotic-assisted walking device<br>|
| Active Comparator: Standard of Care<br>Conventional physical therapy focusing on gait training for five days a week for eight weeks for a total of 40 sessions. | Other: Physical Therapy<br>* Conventional physical therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 10-meter Walking Test (10mWT) |  | Baseline, 1 Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minute Walking Distance (6MWD) |  | Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention |