NCT06387459

Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement

Safety and Feasibility of Knee Extensor Muscle-mimicking, Fabric-type Orthosis on Gait in Geriatric Patients: Pilot Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Objectives: * Primary Objective: To evaluate the safety and feasibility of the fabric-type knee extensor muscle-mimicking orthosis in improving gait among elderly patients. * Secondary Objectives: To measure changes in walking speed, endurance, and muscle activity to infer potential benefits in daily mobility. Study Design: * Study Population: 30 elderly patients suffering from conditions affecting mobility (sarcopenia, diabetes, knee osteoarthritis). * Intervention: Use of a fabric-type orthosis mimicking knee extensor function, equipped with shape-memory alloy for dynamic movement support. * Methodology: 1. Training and Adaptation: Participants will undergo an initial training session to get accustomed to the orthosis, including donning and doffing, adjustment, and use in various environments (flat surfaces, inclines). 2. Assessment Protocol: * Before wearing the orthosis-after wearing the orthosis (power off)-after wearing the orthosis (power on) * Walking environment will include EMG (Electromyography) measurements, 6-minute walk test, 10-meter walk test, and comprehensive gait analysis using platforms like the GAITRite system. * Seating environment will include EMG (Electromyography) measurements and TUG test. 3. Safety Monitoring: Continuous monitoring of physiological responses (blood pressure, heart rate), musculoskeletal assessments, and skin integrity checks to monitor for adverse reactions or discomfort

Conditions

• Gait
• Fall
• Orthotic Devices

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-07-31
• Primary completion: 2025-07-30
• Completion: 2026-05-14
• First posted: 2024-04-29
• Last updated: 2025-06-11

Locations

1 site across 1 country: South Korea