Home-based Exercise Program With Smart Rehabilitation System

Stroke Clinical Trial

— Smart-Rehab  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03282734
• Other study ID #: 2017-07-072
• Status: Completed
• Phase: N/A
• Start date: September 18, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2020
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed Up and Go test	Assessment of balance and gait function	Change from baseline Timed Up and Go test at 4 weeks
Secondary	Tinetti Performance Oriented Mobility Assessment	Assessment of balance and gait function	Change from baseline Timed Up and Go test at 4 weeks
Secondary	Berg Balance scale	Assessment of balance	Change from baseline Timed Up and Go test at 4 weeks
Secondary	Korean-Geriatric Depression Scale- Short Form	Assessment of mood	Change from baseline Timed Up and Go test at 4 weeks
Secondary	EQ-5D	Assessment of quality of life	Change from baseline Timed Up and Go test at 4 weeks
Secondary	Falls Efficacy Scale	Assessment of fall risk	Change from baseline Timed Up and Go test at 4 weeks
Secondary	Korean version of Physical Activity Scale for the Elderly	Assessment of physical activity	Change from baseline Timed Up and Go test at 4 weeks