NCT04610190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

November 4, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

October 26, 2020

Last Update Submit

February 27, 2023

Conditions

Gait Disorders in Old Age

Keywords

Wearable hip assist robotGaitUser testRobot gait trainingElderly

Outcome Measures

Primary Outcomes (1)

  • Change in 10 meter walk test from baseline in gait speed

    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."

    session 0 (initial visit); after session 12 (at approximately 4 weeks); after session 24 (at approximately 8 weeks)

Secondary Outcomes (11)

  • 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)

  • 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)

  • 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)

  • 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)

  • +6 more secondary outcomes

Study Arms (1)

Training with Gait Enhancing and Motivating System (GEMS-H) Robot

EXPERIMENTAL

Training consists of 15 minutes task-specific training and 20-30 minutes functional gait training on varied environments with device.

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

Interventions

Training with Gait Enhancing and Motivating System (GEMS-H) RobotDEVICE

Training consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with device.

Also known as: Training with GEMS-H
Training with Gait Enhancing and Motivating System (GEMS-H) Robot

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 19 - 85 years
  • Living in the community-dwelling with ability to travel to the intervention site to participate in the training program.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Related Publications (1)

  • Lee SH, Kim E, Kim J, Lee HJ, Kim YH. Robot-assisted exercise improves gait and physical function in older adults: a usability study. BMC Geriatr. 2025 Mar 22;25(1):192. doi: 10.1186/s12877-025-05811-1.

    PMID: 40121407DERIVED

Study Officials

  • Yun-Hee Kim, Ph.D

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 26, 2020

First Posted

October 30, 2020

Study Start

November 4, 2020

Primary Completion

March 31, 2021

Study Completion

December 31, 2021

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)