Clinical trial NCT03962517: Effect of GEMS-H on Locomotor Function in Adults
Official title: Effect of GEMS-H on Locomotor Function in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adults
Middle Age
Aged
Aged, 80 and Over
Lead sponsor: Samsung Electronics
Sponsor class: INDUSTRY
First posted: 2019-05-24
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Training in the GEMS-H group consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with device, whereas training in the control group consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments without device.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of training with the Gait Enhancing and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor function in adults. The investigator hypothesizes that long-term GEMS-H use would improve locomotor function. Specifically, individuals in the GEMS-H group will show faster gait speed compared to those in the control group.

Detailed description: The GEMS-H is a hip-type assist device developed by Samsung Electronics. 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. It is controlled through a custom built application on a hand held tablet.

The purpose of this study is to investigate the effect of training with the Gait Enhancing and Motivating System-Hip (GEMS-H) vs. training without the GEMS-H on locomotor function in adults. The investigator hypothesizes that long-term GEMS-H use would improve locomotor function. Specifically, individuals in the GEMS-H group will show faster gait speed compared to those in the control group.

Participants will be scheduled for 18 sessions of training (randomly placed either in GEMS-H training group or traditional training group without the GEM-H) plus 5 sessions of testing (pre-training, mid-test after the 9 sessions of training, post-training, 1 month follow-up and 3 month follow-up after the 18 sessions training completed).

Eligibility criteria: Inclusion Criteria:

* Age: 19 - 84 years
* No history of central nervous system related disease

Exclusion Criteria:

* Difficulty in walking due to conditions such as poor vision or fractures
* Height is less than 140cm or more than 185cm.
* Body mass index (BMI) greater than 35.
* Difficulty understanding and participating in the study such as those with cognitive problems or dementia.
* Subject who is at risk of falling during walking due to severe dizziness

Primary outcomes:
measure: Change in 10 Meter Walk Test-Self Selected Velocity (sec) from Baseline to Post-Training Assessment
timeFrame: Baseline Assessment, Post Training Assessment (6 weeks)
Secondary outcomes:
measure: Change in 10 Meter Walk Test-Fast Velocity (sec) from Baseline
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Change in 10 Meter Walk Test-Self Selected Velocity (sec) from Baseline to Other Assessment Time Points
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Functional Gait Assessment (FGA)
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Functional Reach Test (FRT)
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Four Square Step Test (FSST)
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Five times Sit to Stand (5xSST)
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Berg Balance Scale (BBS)
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Timed Up and Go test (TUG)
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Wearable activity tracker (Measurement: Step count, Calorie consumption, and Heart rate)
timeFrame: Up to Post Training Assessment (Up to 6 weeks)
measure: EuroQol 5 Dimensions (EQ-5D)
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)]
measure: Korean-Modified Barthel Index (K-MBI)
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Fall Efficacy Scale-Korean (FES-K)
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Visual Analogue Scale (VAS)
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Geriatric Depression Scale-a short version (GDS-SF)
timeFrame: Baseline Assessment, Mid Training Assessment (3 weeks), Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Change in Muscle Strength from Baseline
timeFrame: Baseline Assessment, Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Change in Muscle Activation Pattern and Effort (%MVC) during Gait from Baseline
timeFrame: Baseline Assessment, Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Change in Gait Function from Baseline
timeFrame: Baseline Assessment, Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
measure: Change in Cardiopulmonary Metabolic Energy Consumption from Baseline
timeFrame: Baseline Assessment, Post Training Assessment (6 weeks), 1 month Post Training Assessment (1 month Follow-up), 3 month Post Training Assessment (3 month Follow-up)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Yun-Hee Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: