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

NCT04920201 | Completed DMC

• 1 other identifier: 2021-03-052
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aging

Keywords

wearable hip assist robot

Outcome Measures

Primary Outcomes (1)

• 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."

  Baseline, After the intervention(day12)

Secondary Outcomes (10)

• Change from baseline performance on muscle strength after the intervention

  Baseline, After the intervention(day12)

• Change from baseline performance on Short Physical Performance Battery (SPPB) after the intervention

  Baseline, After the intervention(day12)

• Change from baseline performance on Functional Reach Test (FRT) after the intervention

  Baseline, After the intervention(day12)

• Change from baseline performance on Four Square Step Test (FSST) after the intervention

  Baseline, After the intervention(day12)

• Change from baseline performance on Berg Balance Scale (BBS) after the intervention

  Baseline, After the intervention(day12)

Study Arms (4)

Over-ground walking without GEMS-H

EXPERIMENTAL

Other: Over-ground walking without GEMS-H

Over-ground walking with GEMS-H with resist mode

EXPERIMENTAL

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

Stair ascent with GEMS-H with assist mode

EXPERIMENTAL

Device: Stair ascent with GEMS-H with assist mode

Incline walking with GEMS-H with assist mode

EXPERIMENTAL

Device: Incline walking with GEMS-H with assist mode

Interventions

Over-ground walking without GEMS-H OTHER

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

Over-ground walking without GEMS-H

Over-ground walking with GEMS-H with resist mode DEVICE

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

Over-ground walking with GEMS-H with resist mode

Stair ascent with GEMS-H with assist mode DEVICE

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

Stair ascent with GEMS-H with assist mode

Incline walking with GEMS-H with assist mode DEVICE

Incline walking 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

Eligibility Criteria

• Age: 65 Years - 84 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Healthy adults aged 50 to less than 85 years without a history of central nervous system disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 06351, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Single masking (Outcomes Assessor)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr., Ph.D.

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 9, 2021
• Study Start: June 7, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 1, 2023

Record last verified: 2023-02

Locations

KR (1)