Home-based Exercise Program With Smart Rehabilitation System

Overview

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.

Full Title of Study: “Effect of the Home-based Exercise Program With Smart Rehabilitation System on Balance and Gait Functions in Stroke Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2018

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: The smart rehab group
    • Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for 4 weeks
  • Active Comparator: The control group
    • Conventional home rehabilitation exercise education for 4 weeks

Clinical Trial Outcome Measures

Primary Measures

  • Timed Up and Go test
    • Time Frame: Change from baseline Timed Up and Go test at 4 weeks
    • Assessment of balance and gait function

Secondary Measures

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

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 19 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Samsung Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Won Hyuk Chang, Associate Professor – Samsung Medical Center

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.