ClinicalTrials.gov
ClinicalTrials.gov Menu

Home-based Exercise Program With Smart Rehabilitation System (Smart-Rehab)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03282734
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Won Hyuk Chang, 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.

Condition or disease Intervention/treatment Phase
Stroke Other: Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) Other: Conventional home rehabilitation exercise Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : September 18, 2017
Actual Primary Completion Date : June 30, 2018
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Tinetti Performance Oriented Mobility Assessment [ Time Frame: Change from baseline Timed Up and Go test at 4 weeks ]
    Assessment of balance and gait function

  2. Berg Balance scale [ Time Frame: Change from baseline Timed Up and Go test at 4 weeks ]
    Assessment of balance

  3. Korean-Geriatric Depression Scale- Short Form [ Time Frame: Change from baseline Timed Up and Go test at 4 weeks ]
    Assessment of mood

  4. EQ-5D [ Time Frame: Change from baseline Timed Up and Go test at 4 weeks ]
    Assessment of quality of life

  5. Falls Efficacy Scale [ Time Frame: 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 [ Time Frame: Change from baseline Timed Up and Go test at 4 weeks ]
    Assessment of physical activity



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282734


Contacts
Contact: Won Hyuk Chang, MD,PhD 82-2-3410-2818 wh.chang@samsung.com
Contact: Mi Nam Son, PT 82-3410-2832 goodlucktome2@gmail.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
Contact: Won Hyuk Chang, Prof    82-2-3410-6068    wh.chang@samsung.com   
Sponsors and Collaborators
Samsung Medical Center

Responsible Party: Won Hyuk Chang, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT03282734     History of Changes
Other Study ID Numbers: 2017-07-072
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
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:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases