NCT03484624

Brief Summary

The purpose of this study was to investigate the changes in muscle fatigue and respiratory metabolic energy expenditure during walking with wearable hip-assist robot (V3).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

April 2, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

November 4, 2019

Status Verified

March 1, 2018

Enrollment Period

5 months

First QC Date

March 26, 2018

Last Update Submit

October 31, 2019

Conditions

Gait

Keywords

Muscle; FatigueWearable hip assist robotMetabolic energy expenditure

Outcome Measures

Primary Outcomes (1)

  • Change on metabolic energy expenditure

    All subjects underwent measurements of respiratory metabolism energy during treadmill walking at a comfortable speed for 6 minutes and measured by three conditions (①NoGEMS-free gait, ②Torque off with GEMS, and ③Torque on with GEMS). Metabolic energy expenditure and muscle fatigue are measured simultaneously

    1 hour

Secondary Outcomes (1)

  • Change on muscle fatigue

    1 hour

Study Arms (1)

Treadmill walking

EXPERIMENTAL

All subjects underwent measurements of muscle fatigue and respiratory metabolism energy during treadmill walking at a comfortable speed for 6 minutes and measured by three conditions (①NoGEMS-free gait, ②Torque off with GEMS, and ③Torque on with GEMS)

Device: Treadmill walking

Interventions

Treadmill walkingDEVICE

All subjects underwent measurements of muscle fatigue and respiratory metabolism energy during treadmill walking at a comfortable speed for 6 minutes and measured by three conditions (①NoGEMS-free gait, ②Torque off with GEMS, and ③Torque on with GEMS)

Treadmill walking

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Elderly adults over age 65
  • Those without a history of central nervous system disease

You may not qualify if:

  • Those who have problems with walking due to problems such as visual field defects or fractures
  • A person whose height is less than 140 cm or not more than 185 cm
  • Body mass index BMI (body mass index) based on 35 or more obese
  • Those with a cognitive problem that are difficult to understand and participate fully in this study
  • Those who are at risk of falling when walking with serious dizziness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yun-Hee Kim, MD, PhD

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2018

First Posted

April 2, 2018

Study Start

April 2, 2018

Primary Completion

August 31, 2018

Study Completion

August 31, 2018

Last Updated

November 4, 2019

Record last verified: 2018-03

Locations

KR(1)