Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSeoul National University Hospital
About this 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 criteria
Qualifiers
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.
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.
Disqualifiers
Inability to Consent: Unable to provide informed consent or not willing to participate in the study procedures.
Severe Sensory or Motion Limitations: Including severe visual or vestibular impairments that could increase the risk of falling.
Communication Barriers: Significant hearing, speech, or language problems that would hinder communication with study personnel.
Independent Walking Inability: Cannot walk independently without the aid of a walking device.
Trial design
Treatments tested in this trial
- Fabric-Type Knee Extensor Muscle-Mimicking Orthosis
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Seoul National University Hospital
Lead sponsor
Ministry of Science and ICT, Republic of Korea
Collaborator
Source ClinicalTrials.gov