Long-term Exercise Effect of EX1 Exercise Program

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Device: Without Wearable Hip Assist Robot(EX1); Device: Wearable Hip Assist Robot(EX1); Behavioral: Exercise Program 1; Behavioral: Exercise Program 2

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Suwon, Korea, Republic of, 16419
    • Sungkyunkwan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in heart rate	All subjects are measured for heart rate during the intervention.	Every session (total 18 sessions/ 30 minutes)
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.	Session 0 (initial visit); after session 18 (at approximately 6 weeks)
Reduction in body fat percentage	All subjects are measured for body fat before and after the intervention.	Session 0 (initial visit); after session 18 (at approximately 6 weeks)
User Satisfaction Questionnaire	We evaluate the satisfaction questionnaire for EX1 use and exercise program.	After session 18 (at approximately 6 weeks)
Change on gait function (kinematic)	All subjects perform overground walking to assess the change of kinematic using a motion analysis.	Session 0 (initial visit); after session 18 (at approximately 6 weeks)

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: Samsung Electronics

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2023
• Primary Completion (Actual): September 30, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: March 22, 2023
• First Submitted That Met QC Criteria: May 7, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Gait; Exercise program; Wearable hip assist robot
• Other Study ID Numbers: 2023-03-005

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No