Long-term Exercise Effect of EX1 Exercise Program

N/ACompletedNCT05862077

Samsung Medical Center45 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE

Enrollment

Conditions

Aging

Interventions

Wearable Hip Assist Robot(EX1)DEVICE

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

Exercise Program 1BEHAVIORAL

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

Exercise Program 2BEHAVIORAL

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

Eligibility

Sex: ALLMin age: 19 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Sungkyunkwan University

Suwon, South Korea

Outcomes

Primary Outcomes

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

Change in heart rate

All subjects are measured for heart rate during the intervention.

Time frame: 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.

Time frame: 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.

Time frame: 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.

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

Change on gait function (kinematic)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.