Home-based Exercise Program With Smart Rehabilitation System

Study Overview
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Brief Summary
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A lot of patients suffer the balance and gait disorders after stroke. Many rehabilitation therapies have been provided to improve the balance and gait function in stroke patients. However, most rehabilitation therapies are performed in only hospitals, in spite of the difficulty of moving from home to hospitals for stroke patients. Home-based smart rehabilitation system (Uincare®, D-gate Co.) can provide the specific rehabilitation training program to stroke patients in their home. This study aims to investigate the effects of the home-based exercise program with smart rehabilitation system on balance and gait functions in stroke patients.

Detailed Description
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The total 100 patients with stroke will be divided into each the intervention group and the control group. The intervention group will be provided the home-based smart rehabilitation system for 4 weeks, and the control group will be educated the conventional home rehabilitation exercise at once. The immediate effects of the home-based smart rehabilitation system on the balance and gait function will be assessed at 4 weeks after exercise and the long-term carry-over effects will be also assesed at 4 weeks after cessation of exercise.

Official Title
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Effect of the Home-based Exercise Program With Smart Rehabilitation System on Balance and Gait Functions in Stroke Patients

Conditions
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Stroke

Intervention / Treatment
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* Other: Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)
* Other: Conventional home rehabilitation exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult stroke patients (more than 18 years old) less than 6 months after stroke onset discharged to home or the plan to discharge to home less than 3 days independent ambulatory function on even level (4 or more than 4 in Functional Ambulatory Category) Exclusion Criteria: Advanced liver, kidney, cardiac, or pulmonary disease A terminal medical diagnosis consistent with survival < 1 year) Pre-existing and active major neurological disease Pre-existing and active major psychiatric disease Severe language disorders Severe cognitive disorders (10 or less than 10 in K-MMSE)

Ages Eligible for Study
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Minimum Age: 19 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: The smart rehab group<br>Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for 4 weeks | Other: Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)<br>* Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for more than 30 minutes per a day for 4 weeks<br>|
| Active Comparator: The control group<br>Conventional home rehabilitation exercise education for 4 weeks | Other: Conventional home rehabilitation exercise<br>* Conventional home rehabilitation exercise for more than 30 minutes per a day for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timed Up and Go test | Assessment of balance and gait function | Change from baseline Timed Up and Go test at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tinetti Performance Oriented Mobility Assessment | Assessment of balance and gait function | Change from baseline Timed Up and Go test at 4 weeks | 
| Berg Balance scale | Assessment of balance | Change from baseline Timed Up and Go test at 4 weeks | 
| Korean-Geriatric Depression Scale- Short Form | Assessment of mood | Change from baseline Timed Up and Go test at 4 weeks | 
| EQ-5D | Assessment of quality of life | Change from baseline Timed Up and Go test at 4 weeks | 
| Falls Efficacy Scale | Assessment of fall risk | Change from baseline Timed Up and Go test at 4 weeks | 
| Korean version of Physical Activity Scale for the Elderly | Assessment of physical activity | Change from baseline Timed Up and Go test at 4 weeks |