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Completed

NCT Number: NCT05862077

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.

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Key information

Conditions

Aging

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sungkyunkwan University

Suwon, 16419, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wearable Hip Assist Robot(EX1)

Device

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

Exercise Program 1

Behavioral

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

Exercise Program 2

Behavioral

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

Without Wearable Hip Assist Robot(EX1)

Device

Overground walking without EX1

Primary outcomes

  1. Change on gait function (muscle activation)

    Time frame: 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 outcomes

  1. Change in heart rate

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

    All subjects are measured for heart rate during the intervention.

  2. Reduction in stress level

    Time frame: 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

    Time frame: 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

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

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

  5. Change on gait function (kinematic)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Samsung Electronics

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
May 17, 2023
Registry last updated
Feb 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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