NCT05106881

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

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 14, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

November 24, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

October 14, 2021

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."

    Baseline, After 45minutes of functional gait training (one-time experience)

Secondary Outcomes (5)

  • Change in Timed Up and Go test (TUG) from baseline in balance

    Baseline, After 45minutes of functional gait training (one-time experience)

  • Changes in Short Physical Performance Battery (SPPB) from baseline

    Baseline, After 45minutes of functional gait training (one-time experience)

  • Changes in Four Square Step Test (FSST) from baseline

    Baseline, After 45minutes of functional gait training (one-time experience)

  • Change in 6 minute walk test (6MWT) from Baseline

    Baseline, After 45minutes of functional gait training (one-time experience)

  • User Satisfaction Questionnaire

    After 45minutes of functional gait training (one-time experience)

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

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

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
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2021

First Posted

November 4, 2021

Study Start

November 24, 2021

Primary Completion

March 31, 2022

Study Completion

June 30, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Locations

KR(1)