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Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement

NCT06387459 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-06-11

No results posted yet for this study

Summary

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

  • Gait
  • Fall
  • Orthotic Devices

Interventions

DEVICE

Fabric-Type Knee Extensor Muscle-Mimicking Orthosis

The intervention device is a fabric-based orthosis incorporating shape-memory alloy springs designed to mimic the action of knee extensor muscles. The primary function of this orthosis is to provide supplementary support to the knee joint during walking, aiming to stabilize the gait of elderly individuals affected by muscle weakness or degenerative joint conditions. Material: The orthosis is made from a lightweight, flexible fabric that allows for breathability and comfort during extended wear. Mechanism: Embedded within the fabric are shape- memory alloy springs that function similarly to biological muscles.

Sponsors & Collaborators

  • Ministry of Science and ICT, Republic of Korea

    collaborator OTHER_GOV

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • hyungik shin, prof · Seoul National University Hospital

  • Woo Hyung Lee, prof · Seoul National University Hospital

  • Jung hyun Kim, prof · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2025-07-30
Completion
2026-05-14

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06387459 on ClinicalTrials.gov