Home-based Exercise Program With Smart Rehabilitation System

Not Applicable

Completed

• Conditions: Stroke
• Interventions: Other: Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.); Other: Conventional home rehabilitation exercise

• Registration Number: NCT03282734
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-09-10
• Study First Submitted QC: 2017-09-13
• Study First Posted: 2017-09-14
• Study Start: 2017-09-18
• Primary Completion: 2018-06-30
• Study Completion: 2019-12-31
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The smart rehab group	Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)	Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for 4 weeks
The control group	Conventional home rehabilitation exercise	Conventional home rehabilitation exercise education for 4 weeks

Primary Outcome Measures

Name	Time	Method
Timed Up and Go test	Change from baseline Timed Up and Go test at 4 weeks	Assessment of balance and gait function

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of