Clinical trial NCT05106881: Usability and Satisfaction Test to the Wearable Walking-assist Robot (GEMS-H) in the Community-dwelling Healthy Adults
Official title: Usability and Satisfaction Test to the Wearable Walking-assist Robot (GEMS-H) in the Community-dwelling Healthy Adults
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
First posted: 2021-11-04
Enrollment: 225
Sex: ALL
Minimum age (years): 40
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 one-off 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.

Eligibility criteria: Inclusion Criteria:

* Healthy adults aged 40 to less than 85 years without a history of central nervous system disease

Exclusion Criteria:

* Those who have difficulty walking independently due to problems such as visual field defects or fractures
* Those who have difficulty participating in exercise programs due to adult diseases such as uncontrolled hypertension and diabetes
* Those who have difficulty understanding the exercise program due to severe cognitive decline (Korean-Mini-Mental State Examination, K-MMSE≤10)
* Those who are at risk of falling while walking due to severe dizziness
* Those who are less than 140 cm or more than 185 cm in height that is not suitable size for the wearing of the walking assistance robot
* Those who are overweight based on body mass index (BMI) 35 or higher

Primary outcomes:
measure: Change in 10 meter walk test from baseline in gait speed
timeFrame: Baseline, After 45minutes of functional gait training (one-time experience)
Secondary outcomes:
measure: Change in Timed Up and Go test (TUG) from baseline in balance
timeFrame: Baseline, After 45minutes of functional gait training (one-time experience)
measure: Changes in Short Physical Performance Battery (SPPB) from baseline
timeFrame: Baseline, After 45minutes of functional gait training (one-time experience)
measure: Changes in Four Square Step Test (FSST) from baseline
timeFrame: Baseline, After 45minutes of functional gait training (one-time experience)
measure: Change in 6 minute walk test (6MWT) from Baseline
timeFrame: Baseline, After 45minutes of functional gait training (one-time experience)
measure: User Satisfaction Questionnaire
timeFrame: After 45minutes of functional gait training (one-time experience)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: