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

Samsung Medical Center

Status: Completed

Conditions: Stroke

Treatments: Other: Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.); Other: Conventional home rehabilitation exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT03282734

2017-07-072

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

The smart rehab group

Experimental group

Description:

Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for 4 weeks

Treatment:

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

The control group

Active Comparator group

Description:

Conventional home rehabilitation exercise education for 4 weeks

Treatment:

Other: Conventional home rehabilitation exercise