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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04920201
• Other study ID #: 2021-03-052
• Status: Completed
• Phase: N/A
• Start date: June 7, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: February 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 84 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

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)

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)
• 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)
• 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)

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)