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

N/ACompletedNCT04920201

Samsung Medical Center60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

Conditions

Aging

Interventions

Over-ground walking without GEMS-HOTHER

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 modeDEVICE

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 modeDEVICE

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

Eligibility

Sex: ALLMin age: 65 YearsMax age: 84 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

Change from baseline performance on gait speed after the intervention

Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."