Actively Recruiting
Safety and Feasibility of Knee Extensor Muscle-Mimicking Fabric Orthosis to Improve Walking in Elderly Patients: Pilot Clinical Trial
Led by Seoul National University Hospital · Updated on 2025-06-11
30
Participants Needed
1
Research Sites
41 weeks
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
M
Ministry of Science and ICT, Republic of Korea
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new fabric-type orthosis designed to mimic the knee extensor muscles and support walking in elderly individuals with mobility challenges caused by conditions such as sarcopenia, diabetes, or knee osteoarthritis. This pilot clinical trial aims to assess the safety and feasibility of this device, which may help improve gait stability and reduce falls, thereby enhancing quality of life for older adults. The study will include 30 participants aged 65 years and older who experience mobility impairments. The intervention involves wearing a lightweight, breathable fabric orthosis embedded with shape-memory alloy springs that function like biological muscles to support the knee during walking. Participants will first receive training to become familiar with the device, including how to put it on and adjust it, and will practice walking in various environments such as flat surfaces and inclines. Their gait will be assessed under three conditions: before wearing the orthosis, wearing it with power off, and wearing it with power on. Assessments include walking tests, muscle activity measurements, and gait analysis. Throughout the study, participants will undergo continuous monitoring including blood pressure, heart rate, musculoskeletal and skin checks to ensure safety and comfort. Data collected will include completion rates for each assessment condition, walking speed and endurance tests, muscle activity via electromyography, and detailed gait analysis. User feedback will also be gathered to evaluate the device's impact. The study will help determine if this orthosis is a practical and safe option to support mobility in elderly patients.
CONDITIONS
Brief Title
Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 65 years of age or older
- Able to understand and comply with study instructions and procedures
- Have at least one of the following affecting mobility: sarcopenia (with specific muscle strength, function, or mass criteria), diabetes with distal symmetric polyneuropathy and sensory impairments in toes or feet, or knee osteoarthritis with Kellgren-Lawrence grade 2 or higher and persistent pain of at least 3 on the pain scale for 3 months or more
You will not qualify if you...
- Unable to provide informed consent or unwilling to participate
- Severe sensory or motion limitations such as major visual or balance impairments increasing fall risk
- Significant hearing, speech, or language difficulties that impair communication
- Unable to walk independently without a walking device
- Neurological disorders affecting walking (e.g., stroke, Parkinson's disease)
- Severe orthopedic or musculoskeletal conditions impairing lower limb function
- Severe cardiovascular diseases like uncontrolled hypertension or heart failure
- Respiratory diseases requiring regular oxygen therapy
- Receiving active cancer treatment or treated for cancer within the past 3 years (except basal cell carcinoma or localized prostate cancer)
- Severe psychiatric disorders such as schizophrenia or bipolar disorder
- Past severe orthopedic surgeries on lower limbs affecting gait
- Severe back pain or other mobility-impairing conditions not listed above
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo an initial training session to get accustomed to the fabric-type knee extensor muscle-mimicking orthosis, including donning, doffing, adjustment, and use in various walking environments.
1 training visit (in-person)
Duration - Approximately 1 day
Participants wear the orthosis while various assessments are conducted, including walking tests, EMG measurements, gait analysis, and safety monitoring of physiological responses and skin integrity.
1 assessment visit (in-person) immediately post-implementation
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, Jongno, South Korea, 03080
Actively Recruiting
Research Team
J
JungHyun Kim, prof
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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