Clinical trial NCT04610190: Useability Test to the Wearable Walking-assist Robot (GEMS-H) for Normal Adults Including the Elderly
Official title: Useability Test of Gait Enhancing and Motivating System-Hip (GEMS-H)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gait Disorders in Old Age
Keywords: Wearable hip assist robot
Gait
User test
Robot gait training
Elderly
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Samsung Electronics
First posted: 2020-10-30
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in 10 meter walk test from baseline in gait speed
timeFrame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
Secondary outcomes:
measure: Change in Berg Balance Scale (BBS) from baseline in balance
timeFrame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
measure: Change in Timed Up and Go test (TUG) from baseline in balance
timeFrame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
measure: Changes in Functional Reach Test (FRT) from baseline
timeFrame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
measure: Changes in Short Physical Performance Battery (SPPB) from baseline
timeFrame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
measure: Changes in Four Square Step Test (FSST) from baseline
timeFrame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
measure: Changes in EuroQol-5D (EQ-5D) from baseline
timeFrame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
measure: Changes in Fall Efficacy Scale-Korean (FES-K) from baseline
timeFrame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
measure: Change in Muscle Strength from Baseline
timeFrame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
measure: Change in Geriatric Depression Scale (GDS) from Baseline
timeFrame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
measure: Change in 6 minute walk test (6MWT) from Baseline
timeFrame: session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
measure: User Satisfaction Questionnaire
timeFrame: after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: