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Completed

NCT Number: NCT03282734

Home-based Exercise Program With Smart Rehabilitation System

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 06351, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)

Other

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

Conventional home rehabilitation exercise

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: Smart-Rehab

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Sep 14, 2017
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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