Safety and Feasibility of Knee Extensor Muscle-mimicking, Fabric-type Orthosis on Gait in Geriatric Patients: Pilot Clinical Trial
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.
∙ Eligibility for participation in the study requires that all the following criteria are met:
• Age: Participants must be 65 years of age or older.
• Comprehension and Compliance: Able to fully understand and comply with the instructions and study procedures.
• Mobility-Impacting Conditions: Must have at least one of the following conditions affecting mobility: (1)Sarcopenia:
‣ Muscle Strength: Handgrip strength of \<28 kg for men and \<18 kg for women.
⁃ Muscle Function: Short Physical Performance Battery (SPPB) score of 8 or less.
⁃ Muscle Mass: Bioelectrical impedance analysis (BIA) showing muscle mass \<7.0 kg/m² for men and \<5.7 kg/m² for women. (2)Diabetes:
⁃ Diagnosed distal symmetric polyneuropathy.
⁃ Sensory impairments in toes or feet. (3)Knee Osteoarthritis:
⁃ Kellgren-Lawrence grade ≥2.
⁃ Persistent pain (≥3 months) with a severity of at least 3 on the Numerical Rating Scale (NRS).