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Long-term Exercise Effect of EX1 Exercise Program

Sponsor
Samsung Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05862077
Collaborator
Samsung Electronics (Industry)
45
Enrollment
1
Location
3
Arms
9.8
Anticipated Duration (Months)
4.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Wearable Hip Assist Robot(EX1)
  • Behavioral: Exercise Program 1
  • Behavioral: Exercise Program 2
  • Device: Without Wearable Hip Assist Robot(EX1)
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Long-term Exercise Effect of EX1 Exercise Program
Actual Study Start Date :
Mar 7, 2023
Anticipated Primary Completion Date :
Sep 30, 2023
Anticipated Study Completion Date :
Dec 29, 2023

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Overground walking exercise without EX1

Exercise consists of 30 minutes of overground walking.

Device: Without Wearable Hip Assist Robot(EX1)
Overground walking without EX1
Experimental: Exercise program 1 with EX1

Exercise program 1 consists of 30 minutes of overground walking.

Device: Wearable Hip Assist Robot(EX1)
EX1 is a hip-type assist device developed by Samsung Electronics.

Behavioral: Exercise Program 1
Exercise program 1 for fast walking by applying resistance and assist mode of EX1
Experimental: Exercise program 2 with EX1

Exercise program 2 consists of 30 minutes of overground walking.

Device: Wearable Hip Assist Robot(EX1)
EX1 is a hip-type assist device developed by Samsung Electronics.

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

Outcome Measures

Primary Outcome Measures

  1. Change on gait function (muscle activation) [Session 0 (initial visit); after session 18 (at approximately 6 weeks)]

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

Secondary Outcome Measures

  1. Change in heart rate [Every session (total 18 sessions/ 30 minutes)]

    All subjects are measured for heart rate during the intervention.

  2. Reduction in stress level [Session 0 (initial visit); after session 18 (at approximately 6 weeks)]

    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.

  3. Reduction in body fat percentage [Session 0 (initial visit); after session 18 (at approximately 6 weeks)]

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

  4. User Satisfaction Questionnaire [After session 18 (at approximately 6 weeks)]

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

  5. Change on gait function (kinematic) [Session 0 (initial visit); after session 18 (at approximately 6 weeks)]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 65 Years
Sexes Eligible for Study:
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:

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sungkyunkwan University Suwon Korea, Republic of 16419

Sponsors and Collaborators

  • Samsung Medical Center
  • Samsung Electronics

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yun-Hee Kim, Dr., Ph.D., Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT05862077
Other Study ID Numbers:
  • 2023-03-005
First Posted:
May 17, 2023
Last Update Posted:
May 17, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yun-Hee Kim, Dr., Ph.D., Samsung Medical Center
Exercise program
Wearable hip assist robot
Gait

Study Results

No Results Posted as of May 17, 2023