Useability Test of Gait Enhancing and Motivating System-Hip (GEMS-H)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Yun-Hee Kim
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Change in 10 meter walk test from baseline in gait speed
Study Overview
Brief Summary
The purpose of this study is to investigate the userbility and satisfaction of functional gait training with the Gait Enhancing and Motivating System-Hip type (GEMS-H) on locomotor function in normal adults including the elderly.
Detailed Description
The GEMS-H is a hip-type assist device developed by the Samsung Advanced Institute of Technology. The GEMS-H is worn around the waist and fastened at the waist and thighs by a set of belts with velcro to assist motion at the hip joints. The device weighs 2.1kg, and has 2 brushless direct current motors running on a rechargeable lithium ion battery. The normal operation time for the device is 2 hours. The GEMS-H is available in three sizes to fit various waist/hip sizes: small, medium, and large. The width of each version can be adjusted further to fit individual body size within the circumference range. Also, the thigh frames are available in three sizes (large, medium, and small) for different leg lengths. It is controlled through a custom built application on a hand held tablet.
Participants will be normal adults with community-dwelling older adults aged 19-85.
Participants will be scheduled for 24 training sessions of training plus 3 sessions of testing (pre-training, mid-test after the 12 sessions of training, post-training).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age: 19 - 85 years
- •Living in the community-dwelling with ability to travel to the intervention site to participate in the training program.
Exclusion Criteria
- •Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
- •Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
- •BMI ≥ 35 kg/m2
- •Serious medical conditions including myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living, Severe hypertension, severe weight bearing pain, life expectancy less than one year
Outcomes
Primary Outcomes
Change in 10 meter walk test from baseline in gait speed
Time Frame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."
Secondary Outcomes
- Change in Muscle Strength from Baseline(session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks))
- User Satisfaction Questionnaire(after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks))
- Changes in Functional Reach Test (FRT) from baseline(session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks))
- Changes in Short Physical Performance Battery (SPPB) from baseline(session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks))
- Change in Berg Balance Scale (BBS) from baseline in balance(session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks))
- Changes in EuroQol-5D (EQ-5D) from baseline(session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks))
- Changes in Fall Efficacy Scale-Korean (FES-K) from baseline(session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks))
- Change in Timed Up and Go test (TUG) from baseline in balance(session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks))
- Change in Geriatric Depression Scale (GDS) from Baseline(session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks))
- Changes in Four Square Step Test (FSST) from baseline(session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks))
- Change in 6 minute walk test (6MWT) from Baseline(session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks))
Investigators
Yun-Hee Kim
Professor
Samsung Medical Center