CClinicalTrials.gg
CompletedNCT05862077Updated Feb 29, 2024

Long-term Exercise Effect of EX1 Exercise Program

An interventional study of Wearable Hip Assist Robot(EX1) and Exercise Program 1 in Aging, sponsored by Samsung Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 19 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.

Sponsored by Samsung Medical Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
19 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Aging

Keywords

  • Exercise program
  • Wearable hip assist robot
  • Gait
03

In context

Lead sponsor

Samsung Medical Center is the lead sponsor of 980 studies on the registry; 146 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Healthy adults aged 19 to less than 65 years without a history of central nervous system disease

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Sham comparator
    Overground walking exercise without EX1

    Exercise consists of 30 minutes of overground walking.

    Device: Without Wearable Hip Assist Robot(EX1)

  • Experimental
    Exercise program 1 with EX1

    Exercise program 1 consists of 30 minutes of overground walking.

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

  • Experimental
    Exercise program 2 with EX1

    Exercise program 2 consists of 30 minutes of overground walking.

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

Interventions

  • DeviceWearable Hip Assist Robot(EX1)

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

  • BehavioralExercise Program 1

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

  • BehavioralExercise Program 2

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

  • DeviceWithout Wearable Hip Assist Robot(EX1)

    Overground walking without EX1

06

What researchers measure

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).

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

Secondary outcomes

  1. Change in heart rate

    All subjects are measured for heart rate during the intervention.

    Time frame: Every session (total 18 sessions/ 30 minutes)

  2. Reduction in stress level

    We evaluate the subject's usual stress level through a questionnaire. The Perceived Stress Scale (PSS-10) is a 10-item questionnaire originally developed by Cohen et al. (1983) widely used to assess stress levels in young people and adults. The questions ask about feelings and thoughts during the last month. In each case, respondents are asked how often they felt a certain way on a five-point scale from 'never' to 'very often'. Answers are then scored as follow: Never = 0; Almost never = 1; Sometimes = 2; Fairly often = 3; Very often = 4. The PSS score is then obtained by summing across all items. Higher scores indicate higher levels of perceived stress.

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

  3. Reduction in body fat percentage

    All subjects are measured for body fat before and after the intervention.

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

  4. User Satisfaction Questionnaire

    We evaluate the satisfaction questionnaire for EX1 use and exercise program.

    Time frame: After session 18 (at approximately 6 weeks)

  5. Change on gait function (kinematic)

    All subjects perform overground walking to assess the change of kinematic using a motion analysis.

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

07

Study locations

1 site
  • Sungkyunkwan University
    Suwon, 16419, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05862077
Lead sponsor
Samsung Medical Center
Collaborators
Samsung Electronics
Responsible party
Yun-Hee Kim (Dr., Ph.D., Samsung Medical Center) — Principal investigator
First posted
May 17, 2023
Start date
Mar 28, 2023
Primary completion
Sep 30, 2023
Completion
Oct 31, 2023
Last update
Feb 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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