Effect of GEMS-H on Locomotor Function in Adults

NCT03962517 | Completed DMC

• 1 other identifier: 2019-04-063
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Adults; Middle Age; Aged; Aged, 80 and Over

Outcome Measures

Primary Outcomes (1)

• Change in 10 Meter Walk Test-Self Selected Velocity (sec) from Baseline to Post-Training Assessment

  Measure of self-selected walking speeds by measuring the time it takes a participant to walk 10 meters. The test is performed using a "flying start," the participant 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."

  Baseline Assessment, Post Training Assessment (6 weeks)

Secondary Outcomes (19)

• Change in 10 Meter Walk Test-Fast Velocity (sec) from Baseline

  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)

• Change in 10 Meter Walk Test-Self Selected Velocity (sec) from Baseline to Other Assessment Time Points

  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)

• Functional Gait Assessment (FGA)

  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)

• Short Physical Performance Battery (SPPB)

  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)

• Functional Reach Test (FRT)

  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)

Study Arms (2)

Training with GEMS-H

EXPERIMENTAL

Participants will participate in 18 sessions of training + 5 sessions of testing for up to 3 month. Training consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with the device.

Device: with Gait Enhancing and Motivating System-Hip (GEMS-H)

Training without GEMS-H

ACTIVE COMPARATOR

Participants will participate in 18 sessions of training + 5 sessions of testing for up to 3 month. Training consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments without the device.

Other: without Gait Enhancing and Motivating System-Hip (GEMS-H)

Interventions

with Gait Enhancing and Motivating System-Hip (GEMS-H) DEVICE

The intensity of training: between 12 and 16 in borg's rating of perceived exertion scale. Assessments consist of gait function, cardiopulmonary metabolic energy cost, physical performance, balance, physical level, pain, fall efficacy, depression, quality of life and activities of daily living.

Training with GEMS-H

without Gait Enhancing and Motivating System-Hip (GEMS-H) OTHER

The intensity of training: between 12 and 16 in borg's rating of perceived exertion scale.

Training without GEMS-H

Eligibility Criteria

• Age: 19 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Electronics: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Study Officials

• Yun-Hee Kim, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A blinded research physical therapist will test the outcome measure at baseline, mid testing after 9th session of training, at post testing after 18th session of training, at 1 month follow up testing after 18th session of training and at 3 months follow up testing after 18th session of training.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 24, 2019
• Study Start: May 28, 2019
• Primary Completion: February 5, 2020
• Study Completion: February 5, 2020
• Last Updated: April 2, 2020

Record last verified: 2020-03

Locations

KR (1)