Actively Recruiting
Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement
Led by Seoul National University Hospital · Updated on 2025-06-11
30
Participants Needed
1
Research Sites
93 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
This pilot clinical trial assesses the safety and feasibility of a novel fabric-type orthosis designed to mimic the knee extensor muscles and improve gait in elderly patients with mobility impairments due to conditions like sarcopenia, diabetes, or knee osteoarthritis. The study aims to test this orthosis in a real- world setting to see if it can enhance mobility and stability for elderly individuals, potentially reducing falls and improving quality of life. A total of 30 participants aged 65 and older will be recruited to use this orthosis across multiple sessions, where their gait will be analyzed under various conditions to measure the device's impact on walking speed, stability, and muscle activation.
CONDITIONS
Official Title
Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older
- Able to understand and follow study instructions
- Have at least one condition affecting mobility: sarcopenia, diabetes with distal symmetric polyneuropathy and sensory impairments, or knee osteoarthritis with Kellgren-Lawrence grade 2 or higher and persistent pain for 3 months or more
- For sarcopenia: handgrip strength less than 28 kg for men and less than 18 kg for women, Short Physical Performance Battery score of 8 or less, and muscle mass below 7.0 kg/m² for men or 5.7 kg/m² for women
You will not qualify if you...
- Unable or unwilling to give informed consent
- Severe sensory or motion limitations, including visual or balance impairments increasing fall risk
- Significant hearing, speech, or language problems
- Unable to walk independently without a walking device
- Neurological disorders affecting walking (such as stroke or Parkinson's disease)
- Severe orthopedic or musculoskeletal conditions affecting lower limbs
- Severe cardiovascular conditions like uncontrolled hypertension or heart failure
- Respiratory diseases requiring regular oxygen therapy
- Active cancer treatment or treatment within the past 3 years except for 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
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, Jongno, South Korea, 03080
Actively Recruiting
Research Team
J
JungHyun Kim, prof
CONTACT
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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