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

March 16, 2020 updated by: Won Hyuk Chang, Samsung Medical Center

Effect of the Home-based Exercise Program With Smart Rehabilitation System on Balance and Gait Functions in Stroke Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinetti Performance Oriented Mobility Assessment
Time Frame: Change from baseline Timed Up and Go test at 4 weeks
Assessment of balance and gait function
Change from baseline Timed Up and Go test at 4 weeks
Berg Balance scale
Time Frame: Change from baseline Timed Up and Go test at 4 weeks
Assessment of balance
Change from baseline Timed Up and Go test at 4 weeks
Korean-Geriatric Depression Scale- Short Form
Time Frame: Change from baseline Timed Up and Go test at 4 weeks
Assessment of mood
Change from baseline Timed Up and Go test at 4 weeks
EQ-5D
Time Frame: Change from baseline Timed Up and Go test at 4 weeks
Assessment of quality of life
Change from baseline Timed Up and Go test at 4 weeks
Falls Efficacy Scale
Time Frame: Change from baseline Timed Up and Go test at 4 weeks
Assessment of fall risk
Change from baseline Timed Up and Go test at 4 weeks
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
Change from baseline Timed Up and Go test at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2017

Primary Completion (Actual)

June 30, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

September 10, 2017

First Submitted That Met QC Criteria

September 13, 2017

First Posted (Actual)

September 14, 2017

Study Record Updates

Last Update Posted (Actual)

March 18, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-07-072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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