Smart-Rehab: Home-based Exercise Program With Smart Rehabilitation System

Sponsor
Samsung Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT03282734
Collaborator
(none)
100
1
2
27.4
3.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)
  • Other: Conventional home rehabilitation exercise
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of the Home-based Exercise Program With Smart Rehabilitation System on Balance and Gait Functions in Stroke Patients
Actual Study Start Date :
Sep 18, 2017
Actual Primary Completion Date :
Jun 30, 2018
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: The smart rehab group

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.)
Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for more than 30 minutes per a day for 4 weeks

Active Comparator: The control group

Conventional home rehabilitation exercise education for 4 weeks

Other: Conventional home rehabilitation exercise
Conventional home rehabilitation exercise for more than 30 minutes per a day for 4 weeks

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Tinetti Performance Oriented Mobility Assessment [Change from baseline Timed Up and Go test at 4 weeks]

    Assessment of balance and gait function

  2. Berg Balance scale [Change from baseline Timed Up and Go test at 4 weeks]

    Assessment of balance

  3. Korean-Geriatric Depression Scale- Short Form [Change from baseline Timed Up and Go test at 4 weeks]

    Assessment of mood

  4. EQ-5D [Change from baseline Timed Up and Go test at 4 weeks]

    Assessment of quality of life

  5. Falls Efficacy Scale [Change from baseline Timed Up and Go test at 4 weeks]

    Assessment of fall risk

  6. Korean version of Physical Activity Scale for the Elderly [Change from baseline Timed Up and Go test at 4 weeks]

    Assessment of physical activity

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Samsung Medical Center Seoul Korea, Republic of 06351

Sponsors and Collaborators

  • Samsung Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Won Hyuk Chang, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT03282734
Other Study ID Numbers:
  • 2017-07-072
First Posted:
Sep 14, 2017
Last Update Posted:
Mar 18, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2020