Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT06387459

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

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, Jongno, South Korea, 03080

Actively Recruiting

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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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