Gait Clinical Trial - Feasibility of Fabric Orthosis for Knee Support in

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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) - Assessments will include EMG (Electromyography) measurements, 6-minute walk test, 10-meter walk test, and comprehensive gait analysis using platforms like the GAITRite system. 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06387459
Study type	Interventional
Source	Seoul National University Hospital
Contact	JungHyun Kim, prof
Phone	82+1088632341
Email	kiking0@naver.com
Status	Not yet recruiting
Phase	N/A
Start date	May 15, 2024
Completion date	May 14, 2026

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms