Sensory-Motor Rehabilitation Post Stroke

Study Overview
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Brief Summary
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Early after stroke, patients often have significant motor impairment and sensory deficit. Evidence has demonstrated heightened plasticity and significant recovery in the acute phase (first months) post stroke but there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapy.This research study will conduct a randomized clinical trial of an intensive motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation robot. The primary aims are to facilitate sensorimotor recovery, reduce ankle impairments, and improve balance and gait functions. This clinical trial will be conducted on the Study and Control groups of acute stroke survivors.

Detailed Description
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The study will investigate an early intensive rehabilitation in acute stroke for motor relearning, reducing ankle impairments and improving balance and mobility/locomotion functions. The acute stroke survivor will be randomly placed into two groups. Subjects in the Study group will receive robot-aided motor relearning under real-time feedback, stretching under intelligent control, sensory stimulation, and active movement training with interactive games. Subjects in the Control group will receive passive movement in the middle ROM without intelligent stretching and active movement training without robotic guidance. For both groups, the therapeutic training will be conducted during 5 hourly sessions (including breaks/transitions between tasks) each week over about 3-week hospital stay. Both groups will also receive the standard of care in the hospital and rehabilitation service. Treatment outcome measures will be obtained through blinded assessments and evaluated before and after training involving biomechanical, neuromuscular and clinical outcome measures. Carry-over effects will be further evaluated 1 month after the treatment ends. Aim 1: To evaluate biomechanical and neuromuscular changes as defined by the passive and active range of motion (ROM), flexor-extensor muscle strength, joint stiffness, proprioception and reflex excitability, and compare these measures between the two groups. The biomechanical and neuromuscular outcome measures will be obtained through blinded assessments and evaluated before and after training using the wearable rehabilitation robot. Hypothesis 1: Robot-guided motor relearning, stretching and active movement training (Study group) will improve the biomechanical and neuromuscular outcome measures more than those of the Control group. Aim 2: To evaluate the clinical outcome measures as defined by Fugl-Meyer score (lower extremity), modified Ashworth scale, Berg balance scale, 10 meter walk test, and to compare between the Study and Control groups. Hypothesis 2: The Study group will improve the clinical outcome measures more than the Control group.

Official Title
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Sensory-Motor Rehabilitation Post Stroke

Conditions
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Acute Stroke

Intervention / Treatment
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* Device: stretching and active movement training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First time unilateral acute stroke, hemorrhagic or ischemic, 24 hours after admission in hospital to 1 year post stroke. Hemiplegia or hemiparesis Age 18-80 Ankle impairments Exclusion Criteria: No impairment or very mild ankle impairment of ankle. Unstable medical conditions that interferes with ability to training and exercise. Severe cardiovascular disorders that interfere with ability to perform moderate movement exercises. Cognitive impairment or aphasia with inability to follow instructions Pressure ulcer, recent surgical incision or active skin disease with open wounds present below knee of treated limb Severe pain in legs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Study group<br>Subjects in the Study group will receive stretching and active movement training with robotic guidance and intelligent control | Device: stretching and active movement training<br>* A portable rehabilitation robot will be used to strongly or gently move the impaired ankle joint back and forth. Then subjects will be asked to use muscles to move the ankle with or without the robotic guidance depending on which group the subjects are in.<br>|
| Experimental: Control group<br>Subjects in the Control group will receive stretching and active movement training without robotic guidance. | Device: stretching and active movement training<br>* A portable rehabilitation robot will be used to strongly or gently move the impaired ankle joint back and forth. Then subjects will be asked to use muscles to move the ankle with or without the robotic guidance depending on which group the subjects are in.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of Fugl-Meyer Lower Extremity (FMLE) | The assessment is a measure of lower extremity (LE) motor and sensory impairments. | At the beginning and end of 3-week training, and 1 month after the treatment ends | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of active range of motion (AROM) | AROM will be measured in degrees in the ankle joint while subjects use the muscles to move the ankle. | At the beginning and end of 3-week training, and 1 month after the treatment ends | 
| Changes of passive range of motion (PROM) | PROM will be measured in degrees in the ankle joint while the robot moves the ankle of the subject strongly. | At the beginning and end of 3-week training, and 1 month after the treatment ends | 
| Changes of ankle strength | Strength of the ankle flexor-extensor muscle will be measured in Newton | At the beginning and end of 3-week training, and 1 month after the treatment ends | 
| Changes of ankle stiffness | Spasticity will be measured by the resistance torque in Newton-meter under controlled movement at each joint. | At the beginning and end of 3-week training, and 1 month after the treatment ends | 
| Changes of Modified Ashworth Scale (MAS) | The Modified Ashworth Scale is the most widely used assessment tool to measure resistance to limb movement in a clinic setting. Scores range from 0-4, with 6 choices. 0 (0) - No increase in muscle tone; 1 (1) - Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension; 1+ (2) - Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM (range of movement); 2 (3) - More marked increase in muscle tone through most of the ROM, but affect part(s) easily moved; 3 (4) - Considerable increase in muscle tone passive, movement difficult; 4 (5) - Affected part(s) rigid in flexion or extension. | At the beginning and end of 3-week training, and 1 month after the treatment ends | 
| Changes of Berg Balance Scale | The Berg balance scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. | At the beginning and end of 3-week training, and 1 month after the treatment ends | 
| Changes of 10 meter Walk Test | The 10 Metre Walk Test is a performance measure used to assess walking speed in metres per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function. | At the beginning and end of 3-week training, and 1 month after the treatment ends | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Stroke, Robotic therapy, Ankle impairment