The Effect of Exercise With Wearable Walking Assist Robot in Various Environments

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-07

Study Completion Date

2021-09-30

Brief Summary

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This single-blinded, randomized, controlled trial includes 60 healthy adults. The participants were randomized to four different groups. The first group performed over-ground walking without GEMS-H, the second group performed over-ground walking with GEMS-H applied resistance mode, the third group performed stair ascent with GEMS-H applied assist mode, and the fourth group were designated as the group that performed inclined gait with GEMS-H applied assist mode on a treadmill. Each group is divided in 15 participants.

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Detailed Description

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At the first visit, the subjects are fully informed of the study if appropriate after determining whether they meet the selection criteria. If the subjects meet the selection criteria, the participants were randomized to four different groups. The first group performed over-ground walking without GEMS-H, the second group performed over-ground walking with GEMS-H with resistance mode, the third group performed stair ascent with GEMS-H with assist mode, and the fourth group were designated as the group that performed inclined gait with GEMS-H with assist mode on a treadmill. Each group is divided in 15 participants. Each group completed 30 minutes exercise at least three times per week (total 10 sessions). All measurements were conducted before and after the intervention.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Single masking (Outcomes Assessor)

Study Groups

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Over-ground walking without GEMS-H

Group Type EXPERIMENTAL

Over-ground walking without GEMS-H

Intervention Type OTHER

Over-ground walking without GEMS-H (30 min per session, at least 3 times per weeks, total 10 sessions)

Over-ground walking with GEMS-H with resist mode

Group Type EXPERIMENTAL

Over-ground walking with GEMS-H with resist mode

Intervention Type DEVICE

Over-ground walking with GEMS-H with resist mode (30 min per session, at least 3 times per weeks, total 10 sessions)

Stair ascent with GEMS-H with assist mode

Group Type EXPERIMENTAL

Stair ascent with GEMS-H with assist mode

Intervention Type DEVICE

Stair ascent with GEMS-H with assist mode (30 min per session, at least 3 times per weeks, total 10 sessions)

Incline walking with GEMS-H with assist mode

Group Type EXPERIMENTAL

Incline walking with GEMS-H with assist mode

Intervention Type DEVICE

Incline walking with GEMS-H with assist mode (30 min per session, at least 3 times per weeks, total 10 sessions)

Interventions

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Over-ground walking without GEMS-H

Over-ground walking without GEMS-H (30 min per session, at least 3 times per weeks, total 10 sessions)

Intervention Type OTHER

Over-ground walking with GEMS-H with resist mode

Over-ground walking with GEMS-H with resist mode (30 min per session, at least 3 times per weeks, total 10 sessions)

Intervention Type DEVICE

Stair ascent with GEMS-H with assist mode

Stair ascent with GEMS-H with assist mode (30 min per session, at least 3 times per weeks, total 10 sessions)

Intervention Type DEVICE

Incline walking with GEMS-H with assist mode

Incline walking with GEMS-H with assist mode (30 min per session, at least 3 times per weeks, total 10 sessions)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy adults aged 50 to less than 85 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 with severe arthritis or orthopedic problems limiting passive range of motion (ROM) of the lower extremities (knee flexion contracture \>10°, knee flexion ROM \<90°, hip flexion contracture \>25°, ankle plantar flexion contracture \>15°)
* Those who have difficulty understanding the exercise program due to severe cognitive decline (Korean-Mini-Mental State Examination, K-MMSE≤10)
* 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

Minimum Eligible Age

65 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes