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

Samsung Medical Center

Status: Completed

Conditions: Aging

Treatments: Device: Over-ground walking with GEMS-H with resist mode; Device: Incline walking with GEMS-H with assist mode; Other: Over-ground walking without GEMS-H; Device: Stair ascent with GEMS-H with assist mode

Study type: Interventional

Funder types: Other

Identifiers

NCT04920201

2021-03-052

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 65 to 84 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 4 patient groups

Over-ground walking without GEMS-H

Experimental group

Treatment:

Other: Over-ground walking without GEMS-H

Over-ground walking with GEMS-H with resist mode

Experimental group

Treatment:

Device: Over-ground walking with GEMS-H with resist mode

Stair ascent with GEMS-H with assist mode

Experimental group

Treatment:

Device: Stair ascent with GEMS-H with assist mode

Incline walking with GEMS-H with assist mode

Experimental group

Treatment:

Device: Incline walking with GEMS-H with assist mode