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CompletedNCT03282734Smart-RehabUpdated Mar 18, 2020

Home-based Exercise Program With Smart Rehabilitation System

An interventional study of Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) and Conventional home rehabilitation exercise in Stroke, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Stroke

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03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
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

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)
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • 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.)

  • Active comparator
    The control group

    Conventional home rehabilitation exercise education for 4 weeks

    Other: Conventional home rehabilitation exercise

Interventions

  • OtherHome-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

  • OtherConventional home rehabilitation exercise

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

05

What researchers measure

Primary outcomes

  1. Timed Up and Go test

    Assessment of balance and gait function

    Time frame: Change from baseline Timed Up and Go test at 4 weeks

Secondary outcomes

  1. Tinetti Performance Oriented Mobility Assessment

    Assessment of balance and gait function

    Time frame: Change from baseline Timed Up and Go test at 4 weeks

  2. Berg Balance scale

    Assessment of balance

    Time frame: Change from baseline Timed Up and Go test at 4 weeks

  3. Korean-Geriatric Depression Scale- Short Form

    Assessment of mood

    Time frame: Change from baseline Timed Up and Go test at 4 weeks

  4. EQ-5D

    Assessment of quality of life

    Time frame: Change from baseline Timed Up and Go test at 4 weeks

  5. Falls Efficacy Scale

    Assessment of fall risk

    Time frame: Change from baseline Timed Up and Go test at 4 weeks

  6. Korean version of Physical Activity Scale for the Elderly

    Assessment of physical activity

    Time frame: Change from baseline Timed Up and Go test at 4 weeks

06

Study locations

1 site
  • Samsung Medical Center
    Seoul, 06351, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03282734
Lead sponsor
Samsung Medical Center
Responsible party
Won Hyuk Chang (Associate Professor, Samsung Medical Center) — Principal investigator
First posted
Sep 14, 2017
Start date
Sep 18, 2017
Primary completion
Jun 30, 2018
Completion
Dec 31, 2019
Last update
Mar 18, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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