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Long-term Exercise Effect of EX1 Exercise Program

Long-term Exercise Effect of EX1 Exercise Program

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05862077
Enrollment
45
Registered
2023-05-17
Start date
2023-03-28
Completion date
2023-10-31
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Keywords

Exercise program, Wearable hip assist robot, Gait

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.

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

Sponsors

Samsung Electronics
CollaboratorINDUSTRY
Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
Change in heart rateEvery session (total 18 sessions/ 30 minutes)All subjects are measured for heart rate during the intervention.
Reduction in stress levelSession 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.
Reduction in body fat percentageSession 0 (initial visit); after session 18 (at approximately 6 weeks)All subjects are measured for body fat before and after the intervention.
User Satisfaction QuestionnaireAfter session 18 (at approximately 6 weeks)We evaluate the satisfaction questionnaire for EX1 use and exercise program.
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026