Exoskeleton-assisted Upper Limb Rehabilitation After Stroke

Study Overview
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Brief Summary
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In recent studies, it has been observed that robotic devices make a positive contribution to motor recovery and the activities of daily living. However, studies about the effects of stroke rehabilitation with robotic devices are limited. This study aimed to investigate the effect of upper extremity robotic rehabilitation on motor function and quality of life in stroke patients.

Detailed Description
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Stroke survivors have difficulties in participating in activities of daily living due to functional disabilities. The majority of patients after stroke need rehabilitation to gain independence in daily life as the first target. Therefore, different treatment approaches are used in stroke rehabilitation. The use of technology in stroke rehabilitation has become very common in recent years. Robotic devices used in rehabilitation enhance the healing process by giving patients more intensive and task-oriented exercises. A lot of systematic and meta-analysis studies have shown that robot-assisted devices provide positive motor recoveries, especially in the treatment of upper extremities. However, the optimal timing, duration, and dose of robotic rehabilitation that should be applied after stroke remain uncertain. In the light of this information, this study examines the effects of the robotic device produced for upper limb rehabilitation on daily life activities and motor function.

Official Title
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Exoskeleton-assisted Upper Limb Rehabilitation After Stroke: A Randomized Controlled Trial

Conditions
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Stroke, Upper Extremity Dysfunction

Intervention / Treatment
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* Device: Exoskeleton robot for upper extremity
* Other: Conventional physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having ischemic or hemorrhagic stroke history Being at the age between 40 and 85 MAS (Modified Ashworth Scale) < 3 for upper extremity At least 6 months after stroke Participants who agree to participate in the study Exclusion Criteria: Cardiovascular weakness (severe hypertension, coronary artery disease) Mini-Mental State Examination score < 24 Recurrent stroke Having other orthopedic and neurologic conditions that may affect upper extremity movement Having behavioral and cognitive problems

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robot-assisted Treatment<br>Rehabilitation protocol was applied with robotic device (HOUSTONBIONİCS ExoRehab UE1). | Device: Exoskeleton robot for upper extremity<br>* Robot-assisted Treatment Program: 10 minutes elbow flexion/extension 10 minutes forearm supination/pronation 10 minutes wrist flexion/extension 10 minutes ulnar/radial deviation Frequency: 2/week Duration: 12 sessions (6 weeks)<br>|
| Active Comparator: Conventional Physiotherapy<br>Conventional physiotherapy program included neurophysiological approaches. | Other: Conventional physiotherapy<br>* Ferquency: 2/week Duration: 12 sessions (6weeks) Each session: 50 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Upper Extremity Assessment | Fugl-Meyer Upper Extremity Assessment is an index to assess physical performance in individuals who had a stroke. This index consists of 33 items. Each item scored between 0 and 2. The highest score for the upper extremity is 66. | before treatment and at six weeks of the beginning of the treatment | 
| Modified Ashworth Scale | Modified Ashworth Scale is used for measuring the spasticity of upper extremity skeletal muscle. The Modified Ashworth Scale (MAS) is scored from 0 to 5 to measure the resistance encountered when performing passive muscle stretching. The lowest score is 0 (no spasticity) and the highest score is 5 (severe spasticity). | before treatment and at six weeks of the beginning of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Upper Extremity Motor Activity Log | Upper Extremity Motor Activity Log consists of two subscales (amount of use and quality of movement) that determine how often the patient uses the affected side in daily life activities and how successful this activity is. Items on each scale are scored between 0 and 5. | before treatment and at six weeks of the beginning of the treatment | 
| Nottingham Extended Activities of Daily Living Scale | Nottingham Extended Activities of Daily Living Scale is designed for stroke patients but can be also used for other diseases. The scale has 22 items divided into 4 areas of daily life. These areas are mobility, kitchen, domestic and leisure activities. Each item scored between 0 and 3. The highest score of scale is 66. | before treatment and at six weeks of the beginning of the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Upper extremity, Robotic rehabilitation, Motor function, Quality of life