Clinical trial NCT03282734: Home-based Exercise Program With Smart Rehabilitation System
Official title: Effect of the Home-based Exercise Program With Smart Rehabilitation System on Balance and Gait Functions in Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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)

Primary outcomes:
measure: Timed Up and Go test
timeFrame: Change from baseline Timed Up and Go test at 4 weeks
Secondary outcomes:
measure: Tinetti Performance Oriented Mobility Assessment
timeFrame: Change from baseline Timed Up and Go test at 4 weeks
measure: Berg Balance scale
timeFrame: Change from baseline Timed Up and Go test at 4 weeks
measure: Korean-Geriatric Depression Scale- Short Form
timeFrame: Change from baseline Timed Up and Go test at 4 weeks
measure: EQ-5D
timeFrame: Change from baseline Timed Up and Go test at 4 weeks
measure: Falls Efficacy Scale
timeFrame: Change from baseline Timed Up and Go test at 4 weeks
measure: Korean version of Physical Activity Scale for the Elderly
timeFrame: Change from baseline Timed Up and Go test at 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: