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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Fabric-Type Knee Extensor Muscle-Mimicking Orthosis
DeviceThe 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Knee Extensor Muscle-Mimicking OrthosisExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Completion Rate
The proportion of participants who complete the study as per the protocol, which indicates the orthosis's acceptability and the study's overall manageability.
Time frame
1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)Secondary outcomes
1
Dropout Rate
Measures participant retention throughout the study, providing insights into the orthosis's usability and participant satisfaction.
Time frame
1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)2
User Feedback
Collected using the Quebec User Evaluation of Satisfaction with assistive Technology 2.0 (QUEST 2.0), which will cover aspects such as the orthosis's comfort, ease of use, safety, and effectiveness. This feedback is vital for understanding user satisfaction and for guiding future improvements.
Time frame
1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)3
6-Minute Walk Test
To measure the distance covered in six minutes as a test of aerobic capacity and endurance, which may improve with the use of the orthosis.
Time frame
1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)4
10-Meter Walk Test
To assess changes in basic walking speed over a short distance, reflecting potential improvements in mobility.
Time frame
1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Hospital
Lead sponsor
Ministry of Science and ICT, Republic of Korea
Collaborator
Source ClinicalTrials.gov