Clinical trial NCT04920201: The Effect of Exercise With Wearable Walking Assist Robot in Various Environments
Official title: The Effect of Exercise With Wearable Walking Assist Robot in Various Environments in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: wearable hip assist robot
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline performance on gait speed after the intervention
timeFrame: Baseline, After the intervention(day12)
Secondary outcomes:
measure: Change from baseline performance on muscle strength after the intervention
timeFrame: Baseline, After the intervention(day12)
measure: Change from baseline performance on Short Physical Performance Battery (SPPB) after the intervention
timeFrame: Baseline, After the intervention(day12)
measure: Change from baseline performance on Functional Reach Test (FRT) after the intervention
timeFrame: Baseline, After the intervention(day12)
measure: Change from baseline performance on Four Square Step Test (FSST) after the intervention
timeFrame: Baseline, After the intervention(day12)
measure: Change from baseline performance on Berg Balance Scale (BBS) after the intervention
timeFrame: Baseline, After the intervention(day12)
measure: Change from baseline performance on Timed Up and Go test (TUG) after the intervention
timeFrame: Baseline, After the intervention(day12)
measure: Change from baseline performance on Geriatric Depression Scale (GDS) after the intervention
timeFrame: Baseline, After the intervention(day12)
measure: Change from baseline performance on EuroQol 5 Dimensions (EQ-5D) after the intervention
timeFrame: Baseline, After the intervention(day12)
measure: Change from baseline performance on Fall Efficacy Scale-Korea (FES-K) after the intervention
timeFrame: Baseline, After the intervention(day12)
measure: Change from baseline performance on metabolic energy expenditure after the intervention
timeFrame: Baseline, After the intervention(day12)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References: