Using Upper Limb Rehabilitation Robot in Stroke Patient Rehabilitation

Study Overview
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Brief Summary
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A robot arm for upper limb rehabilitation is intended to achieve rehabilitation effects through the study of robot control theory and the integration of sensors such as sEMG. The goal is to reduce the workload of rehabilitation therapists.

Detailed Description
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NTUH-ii is an upper limb rehabilitation robot. The aim of this robot is to reduce the workload of rehabilitation therapists and make the rehabilitation process more effective. The robot can complete rehabilitation tasks, such as elbow flexion/extension, shoulder flexion/extension, and shoulder horizontal abduction/adduction, etc. By giving the desired trajectory, the robot can lead patients to do the tasks in passive mode or active mode. However, curative rehabilitation should include the motion intention of patients. This study aimed to investigate the efficacy of rehabilitation effect by combining the sensors (such as sEMG, IMU) to obtain the motion intention of patients and give the assistive movement.

Official Title
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Effect on Upper Limb Training Using Rehabilitation Robot With Human-Computer Interaction Game Interface for Stroke Patients

Conditions
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Stroke, Rehabilitation

Intervention / Treatment
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* Device: NTUH-ii, am upper limb rehabilitation robot arm
* Other: Traditional upper limb physical therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: First-time stroke, occurring between 2 weeks and 2 years after onset, resulting in unilateral hemiplegia. Able to understand and follow simple instructions. Able to maintain a sitting posture balance. Rank on the Brunnstrom Scale is between two and five. Both ischemic and hemorrhagic strokes are included. Exclusion Criteria: Not yet fully conscious. Suffering from a psychiatric disorder or post-stroke psychiatric abnormalities. Cognitive or behavioral impairments that affect the ability to comprehend or execute the experimental tasks. Severe aphasia preventing compliance with researchers' instructions for this study. Medical conditions in internal medicine that jeopardize patient safety, such as severe heart or lung diseases, or patients requiring bed rest. Patients with a severe systemic illness requiring bed rest. Patients with shoulder joint pathology unable to undergo exercise therapy. Patients with severe osteoporosis who have concerns about fractures during physical activity. Patients with arrhythmia and implanted cardiac pacemakers. Severe uncontrolled seizures that cannot be improved with medication, physical therapy, botulinum toxin injections, or phenol block procedures.

Ages Eligible for Study
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Minimum Age: 20 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rehabilitation by rehabilitation robot<br>Rehabilitation therapists will determine the training mode based on the subject's movement ability. Passive training mode Active-assistive training mode | Device: NTUH-ii, am upper limb rehabilitation robot arm<br>* Rehabilitation programs are planned based on the subject's capabilities, and the differences between assisted rehabilitation with a robot and traditional rehabilitation are compared.<br>|
| Active Comparator: Traditional rehabilitation<br>Traditional upper limb physical therapy is performed by the therapist. | Other: Traditional upper limb physical therapy<br>* Traditional upper limb physical therapy is performed by the therapist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment | Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment | Fugl-Meyer assessment upper extremity, higher scores indicate a better outcome. | Before the task and right away the experiment, 3 months, 6 months post intervention. | 
| sEMG analyzation | using sEMG sensors to obtain the sEMG signal and applying 3×2 ANOVA to analyze. | Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention. | 
| Modified Ashworth Scale | To measure the increase of muscle tone, score from 0 to 4, higher scores indicate the higher muscle tone. | Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention. | 
| Wolf Motor Function Test | To quantify upper extremity movement ability through timed single- or multiple-joint motions .and functional tasks. | Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention. | 
| Stroke Impact Scale | A self-report questionnaire that evaluates disability and health-related quality of life after stroke. Score from 0 to 100, Higher scores indicate a better outcome. | Before the task, right away the experiment and 1 month, 3 months, 6 months post intervention. |