Back to resultsHome-based Exercise Program With Smart Rehabilitation System (Smart-Rehab)
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)
Conventional home rehabilitation exercise
Sponsored by
About this trial
This is an interventional treatment trial for Stroke
Eligibility Criteria
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)
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
The smart rehab group
The control group
Arm Description
Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for 4 weeks
Conventional home rehabilitation exercise education for 4 weeks
Outcomes
Primary Outcome Measures
Timed Up and Go test
Assessment of balance and gait function
Secondary Outcome Measures
Tinetti Performance Oriented Mobility Assessment
Assessment of balance and gait function
Berg Balance scale
Assessment of balance
Korean-Geriatric Depression Scale- Short Form
Assessment of mood
EQ-5D
Assessment of quality of life
Falls Efficacy Scale
Assessment of fall risk
Korean version of Physical Activity Scale for the Elderly
Assessment of physical activity
Full Information
NCT ID
NCT03282734
First Posted
September 10, 2017
Last Updated
March 16, 2020
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03282734
Brief Title
Home-based Exercise Program With Smart Rehabilitation System
Acronym
Smart-Rehab
Official Title
Effect of the Home-based Exercise Program With Smart Rehabilitation System on Balance and Gait Functions in Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 18, 2017 (Actual)
Primary Completion Date
June 30, 2018 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The smart rehab group
Arm Type
Experimental
Arm Description
Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for 4 weeks
Arm Title
The control group
Arm Type
Active Comparator
Arm Description
Conventional home rehabilitation exercise education for 4 weeks
Intervention Type
Other
Intervention Name(s)
Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)
Intervention Description
Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for more than 30 minutes per a day for 4 weeks
Intervention Type
Other
Intervention Name(s)
Conventional home rehabilitation exercise
Intervention Description
Conventional home rehabilitation exercise for more than 30 minutes per a day for 4 weeks
Primary Outcome Measure Information:
Title
Timed Up and Go test
Description
Assessment of balance and gait function
Time Frame
Change from baseline Timed Up and Go test at 4 weeks
Secondary Outcome Measure Information:
Title
Tinetti Performance Oriented Mobility Assessment
Description
Assessment of balance and gait function
Time Frame
Change from baseline Timed Up and Go test at 4 weeks
Title
Berg Balance scale
Description
Assessment of balance
Time Frame
Change from baseline Timed Up and Go test at 4 weeks
Title
Korean-Geriatric Depression Scale- Short Form
Description
Assessment of mood
Time Frame
Change from baseline Timed Up and Go test at 4 weeks
Title
EQ-5D
Description
Assessment of quality of life
Time Frame
Change from baseline Timed Up and Go test at 4 weeks
Title
Falls Efficacy Scale
Description
Assessment of fall risk
Time Frame
Change from baseline Timed Up and Go test at 4 weeks
Title
Korean version of Physical Activity Scale for the Elderly
Description
Assessment of physical activity
Time Frame
Change from baseline Timed Up and Go test at 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Home-based Exercise Program With Smart Rehabilitation System
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