Meaningful change and responsiveness in common physical performance measures in older adults.
Subashan Perera, Samir H Mody, Richard C Woodman...
https://pubmed.ncbi.nlm.nih.gov/16696738Actively Recruiting
Phase 4
Age: 19Years +
All Genders
ID07147543
Study to Verify the Effectiveness and Safety of the Electrically Powered Orthopedic Exercise Device on Gait Ability in Patients With Gait Disorders: Investigator-Initiated, Single-Center, Single-Group Clinical Trial
Led by Yonsei University · Updated on 2025-08-29
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness and safety of a new electrically powered orthopedic exercise device designed to help people with gait disorders, which are common in older adults due to aging and related declines in nervous, cardiovascular, respiratory, or musculoskeletal systems. Gait problems can reduce quality of life by increasing fall risk and limiting daily activities. This pilot study aims to assess changes in walking and balance when using the device to understand its potential clinical benefits. The study involves 30 participants who will undergo several assessments of their walking and balance abilities without wearing the device, followed by four adaptation sessions where they wear the device and walk short distances to get used to its operation and fit. After these sessions, participants will be tested again while wearing the device using the same walking and balance tests. The device settings will be personalized to each participant to minimize discomfort or anxiety. A satisfaction survey will be completed at the end of the study. Participants will take part in various tests including the 10-Meter Walk Test, 6-Minute Walk Test, Timed Up and Go Test, and Berg Balance Scale both before and after adapting to the device. These assessments will be supervised by medical professionals in a rehabilitation setting, with rest periods provided between tests. Researchers will measure gait parameters such as step count, cadence, walking speed, distance, and stride length. The study will also collect feedback on how usable and satisfactory the device is. The total study participation spans the initial screening, adaptation sessions, and final evaluation within a few weeks.
CONDITIONS
Brief Title
Effectiveness and Safety of Electrically Powered Orthopedic Exercise Device for Gait Disorders
Who Can Participate
Age: 19Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 19 years or older
- Patients experiencing subjective gait or balance disorders
- Individuals who visited Yongin Severance Hospital, understood the study, voluntarily agreed to participate, and signed the consent form
- Patients with a Functional Ambulatory Category (FAC) score of less than 4
- Individuals who can sit on the edge of a bed without assistance and stand for 10 seconds with or without support
- Individuals with sufficient cognitive ability to follow and understand simple instructions (Mini-Mental State Examination score 60 20)
You will not qualify if you...
- Individuals with contraindications to weight-bearing in the lower extremities, such as severe lower extremity joint contractures, osteoporosis, or untreated fractures
- Individuals who cannot wear the device due to skin diseases or open wounds
- Individuals with a significant discrepancy in lower extremity length
- Individuals with severe lower extremity deformities or joint contractures
- Individuals unable to maintain a sitting or standing posture independently
- Individuals with severe cognitive impairment (Mini-Mental State Examination score < 20), delirium, or severe speech impairment preventing cooperation in wearing the device
- Individuals unable to stand or walk for extended periods due to underlying conditions such as orthostatic hypotension or reduced cardiopulmonary function
- Pregnant or potentially pregnant individuals
- Individuals with other clinically significant conditions deemed inappropriate for this study by the principal investigator or research team based on medical judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Evaluation Without Device
Duration - 1 day
Participants undergo assessments of walking ability and balance without wearing the Electrically Powered Orthopedic Exercise Device. A 10-minute rest period is provided between each assessment, with additional rest allowed upon request.
1 visit (in-person)
Pre-Adaptation Phase
Duration - Up to 8 weeks
Participants complete four adaptation sessions wearing the device to become familiar with its operation and wearing method. Each session involves short-distance walking within 10 meters and is spaced within two-week intervals.
4 visits (in-person), approximately biweekly
Evaluation With Device
Duration - 1 day
After completing adaptation sessions, participants undergo assessments of walking ability and balance while wearing the device, followed by a usability and satisfaction survey. Rest periods are provided between assessments as needed.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, South Korea, South Korea, 16995
Actively Recruiting
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Research Team
N
Na Young Kim, MD, PhD
H
Hwi Woo Yang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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