NCT05862077

Brief Summary

The purpose of this study was to investigate the effect of a long-term exercise program using a wearable exoskeleton robot (EX1) on muscular strength in healthy adults aged 19 to under 65 years, compared to an exercise program without EX1.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

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

March 22, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

March 28, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

February 29, 2024

Status Verified

February 1, 2024

Enrollment Period

6 months

First QC Date

March 22, 2023

Last Update Submit

February 28, 2024

Conditions

Aging

Keywords

Exercise programWearable hip assist robotGait

Outcome Measures

Primary Outcomes (1)

  • Change on gait function (muscle activation)

    All subjects perform overground walking to assess the change of muscle activation after the interventions using a surface EMG (6 channels).

    Session 0 (initial visit); after session 18 (at approximately 6 weeks)

Secondary Outcomes (5)

  • Change in heart rate

    Every session (total 18 sessions/ 30 minutes)

  • Reduction in stress level

    Session 0 (initial visit); after session 18 (at approximately 6 weeks)

  • Reduction in body fat percentage

    Session 0 (initial visit); after session 18 (at approximately 6 weeks)

  • User Satisfaction Questionnaire

    After session 18 (at approximately 6 weeks)

  • Change on gait function (kinematic)

    Session 0 (initial visit); after session 18 (at approximately 6 weeks)

Study Arms (3)

Overground walking exercise without EX1

SHAM COMPARATOR

Exercise consists of 30 minutes of overground walking.

Device: Without Wearable Hip Assist Robot(EX1)

Exercise program 1 with EX1

EXPERIMENTAL

Exercise program 1 consists of 30 minutes of overground walking.

Device: Wearable Hip Assist Robot(EX1)Behavioral: Exercise Program 1

Exercise program 2 with EX1

EXPERIMENTAL

Exercise program 2 consists of 30 minutes of overground walking.

Device: Wearable Hip Assist Robot(EX1)Behavioral: Exercise Program 2

Interventions

Wearable Hip Assist Robot(EX1)DEVICE

EX1 is a hip-type assist device developed by Samsung Electronics.

Exercise program 1 with EX1Exercise program 2 with EX1
Exercise Program 1BEHAVIORAL

Exercise program 1 for fast walking by applying resistance and assist mode of EX1

Exercise program 1 with EX1
Exercise Program 2BEHAVIORAL

Exercise program 2 for normal walking by applying resistance and assist mode of EX1

Exercise program 2 with EX1
Without Wearable Hip Assist Robot(EX1)DEVICE

Overground walking without EX1

Overground walking exercise without EX1

Eligibility Criteria

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

You may qualify if:

  • Healthy adults aged 19 to less than 65 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 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)

Sungkyunkwan University

Suwon, 16419, South Korea

Location

Related Publications (1)

  • Lee SH, Kim E, Kim J, Kim D, Lee D, Lee HJ, Kim YH. Effect of Programed Walking Exercise Using Bot Fit in Younger Adults. Sports Med Open. 2024 Oct 14;10(1):112. doi: 10.1186/s40798-024-00773-x.

    PMID: 39400778DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr., Ph.D.

Study Record Dates

First Submitted

March 22, 2023

First Posted

May 17, 2023

Study Start

March 28, 2023

Primary Completion

September 30, 2023

Study Completion

October 31, 2023

Last Updated

February 29, 2024

Record last verified: 2024-02

Locations

KR(1)