A Smart Home-based Exoskeleton Robot System for Stroke Patients

Study Overview
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Brief Summary
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In the proposed study, the investigators assumed that high dose of repetitive motor task training using an exoskeleton robot-assisted system may provide benefits in motor shaping and greater brain priming for hand paresis of the stroke patients. Nevertheless, the amount of therapeutic activity with clinicians' guidance is often short of number in therapy sessions.Therefore, using Internet of Things (IoT), connected rehabilitation products and the data they generate that are a new trend of rehabilitation strategy for providing remote home-programs support. The specific aim of this study is to to explore the feasibility of introducing the rental services of a Smart Home-based Exoskeleton Robot System through the IoT business model. And the second purpose is to investigate the effects of applying the exoskeleton robotic device for tenodesisgrip training as a home-based treatment for chronic stroke patients.The expected outcomes of this research are to clarify the feasibility of using IoT business model for launching smart rehabilitation device rental service and the effects of application a high dosage of hand movement training as home program on motor and hand function for patients with chronic stroke.

Official Title
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Development of a Smart Home-based Exoskeleton Robot System and Innovative Service Model for Stroke Patients

Conditions
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Rehabilitation, Tenodesis, Stroke, Internet of Things

Intervention / Treatment
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* Other: occupational therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) chronic stroke patients with unilateral cerebral infarction or hemorrhage, (2) computed tomography scan that excluded pathologies other than unilateral cerebral hemisphere injury, (3) capacity to perform a pinch task with the thumb and index finger, (4) no major cognitive or perceptual deficit (i.e., visual, auditory, perceptual, praxis, and memory, as determined using Lowenstein occupational therapy cognitive assessment), (5) premorbid right-handedness and (6) first-ever stroke. Exclusion Criteria: not meeting inclusion criteria, and with Wernicke's aphasia or global aphasia leading to difficulty of following instruction.

Ages Eligible for Study
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Minimum Age: 20 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot training with Smart Home-based Exoskeleton Robot System<br>In addition to receiving hospital occupational therapy training twice a week, the participants will receive 60 minutes of home-based robot assisted tenodesis-grip training per day, 5 days a week, for 4 weeks . | Other: occupational therapy<br>* occupational therapy targeted to goals that are relevant to the functional needs of the patient<br>|
| Active Comparator: control group<br>In addition to receiving hospital occupational therapy training twice a week, the participants will receive 60 minutes of home-based specific motor task training per day, 5 days a week, for 4 weeks . | Other: occupational therapy<br>* occupational therapy targeted to goals that are relevant to the functional needs of the patient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the result of Box and blocks test | The score is the number of blocks carried from one box to the other in one minute. Higher values represent a better outcome. | baseline, 4 weeks, 16 weeks and 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the result of Fugl-Meyer assessment for UE motor function | Each item is rated on a three-point ordinal scale (2 points for the detail being performed completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity.completely, 1 point for the detail being performed partially, and 0 for the detail not being performed). The maximum motor performance score is 66 points for the upper extremity. | baseline, 4 weeks, 16 weeks and 20 weeks | 
| Change in the result of Modified Ashworth scale (MAS) | Muscle tone is defined by the resistance of a muscle being stretched without resistance. | baseline, 4 weeks,16 weeks and 20 weeks | 
| Change in the result of Semmes-Weinstein monofilament (SWM) test | The Semmes-Weinstein monofilamenttest examines the cutaneous pressure threshold, range from 1.65-6.65. Higher values represent a worse outcome. | baseline, 4 weeks,16 weeks and 20 weeks | 
| Change in the result of Motor Activity Log | MAL is a structured interview with testing sensitivity used to examine how much (amount of use, AOU) and how well (quality of movement, QOM) the subject uses their more-affected arm. For the 30 items MAL, each item is scored on a 0-5-ordinal scale. | baseline, 4 weeks,16 weeks and 20 weeks | 
| Clinical global impression scale | Self-reported improvement over the treatment period,. The scale, rated from 1 (very much improved) to 7 (very much worse), is as the indicator for determining perceptible change of the patients for assisted tenodeis-grip robot system. | post-intervention (week 4) |