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

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

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.

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Other: Over-ground walking without GEMS-H; Device: Over-ground walking with GEMS-H with resist mode; Device: Stair ascent with GEMS-H with assist mode; Device: Incline walking with GEMS-H with assist mode

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 84 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Over-ground walking without GEMS-H	Other: 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)
Experimental: Over-ground walking with GEMS-H with resist mode	Device: 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)
Experimental: Stair ascent with GEMS-H with assist mode	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)
Experimental: Incline walking with GEMS-H with assist mode	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline performance on muscle strength after the intervention	All subjects underwent measurements of muscle strength of lower extremity by using Commander Echo Muscle Tester (measures in lb, kg, N)	Baseline, After the intervention(day12)
Change from baseline performance on Short Physical Performance Battery (SPPB) after the intervention	The Short Physical Performance Battery (SPPB) is a series of tests used to evaluate lower extremity function and mobility.	Baseline, After the intervention(day12)
Change from baseline performance on Functional Reach Test (FRT) after the intervention	Functional Reach Test (FRT) is a clinical outcome measure and assessment tool for ascertaining dynamic balance in one simple task.	Baseline, After the intervention(day12)
Change from baseline performance on Four Square Step Test (FSST) after the intervention	Four Square Step Test (FSST) is a test of dynamic balance and coordination that clinically assesses the participant's ability to step over objects forward, sideways, and backwards.	Baseline, After the intervention(day12)
Change from baseline performance on Berg Balance Scale (BBS) after the intervention	Berg Balance Scale (BBS) is a 14-item objective measure that assesses static balance and fall risk in adults.	Baseline, After the intervention(day12)
Change from baseline performance on Timed Up and Go test (TUG) after the intervention	The Timed Up and Go test (TUG) is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.	Baseline, After the intervention(day12)
Change from baseline performance on Geriatric Depression Scale (GDS) after the intervention	The Geriatric Depression Scale (GDS) is a self-report measure of depression.	Baseline, After the intervention(day12)
Change from baseline performance on EuroQol 5 Dimensions (EQ-5D) after the intervention	EQ-5D is an instrument which evaluates the generic quality of life developed in Europe and widely used. The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	Baseline, After the intervention(day12)
Change from baseline performance on Fall Efficacy Scale-Korea (FES-K) after the intervention	The Falls Efficacy Scale (FES) is a ten-item test rated on a 10-point scale from not confident at all to completely confident.	Baseline, After the intervention(day12)
Change from baseline performance on metabolic energy expenditure after the intervention	All subjects underwent measurements respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes. It assess the change of metabolic energy expenditure using a portable cardiopulmonary metabolic system (K5, Rome, Italy).	Baseline, After the intervention(day12)

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2021
• Primary Completion (Actual): September 30, 2021
• Study Completion (Actual): September 30, 2021

Study Registration Dates

• First Submitted: June 1, 2021
• First Submitted That Met QC Criteria: June 7, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: wearable hip assist robot
• Other Study ID Numbers: 2021-03-052

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No