Fabric knee orthosis that supports knee extension to improve walking in older adults

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

This project will try a soft fabric knee device with shape‑memory alloy to see if it helps people 65 and older with sarcopenia, diabetic neuropathy, or knee osteoarthritis walk faster and more steadily.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Seoul National University Hospital (Academic / other)
• Locations: 1 site (Seoul, Jongno)
• Trial ID: NCT06387459 on ClinicalTrials.gov

What this trial studies

This is a pilot interventional study enrolling 30 people aged 65 and older with mobility-impairing conditions to test a fabric-type knee orthosis designed to mimic knee extensor muscles using shape‑memory alloy for dynamic support. Participants receive training on donning, doffing, and using the device across different environments, then complete gait and function tests with the device off and on, including EMG, 6‑minute walk, 10‑meter walk, TUG, and GAITRite analysis. Safety monitoring includes blood pressure, heart rate, musculoskeletal checks, and skin integrity assessments during sessions. The primary goal is to determine safety and feasibility and to collect preliminary data on walking speed, endurance, and muscle activation changes.

Who should consider this trial

Good fit: Ideal candidates are people aged 65 or older who have mobility impairment from sarcopenia (low grip strength/SPPB/muscle mass), distal diabetic polyneuropathy with sensory loss in the feet, or knee osteoarthritis (Kellgren‑Lawrence grade ≥2 with chronic pain).

Not a fit: People without the targeted conditions, those with severe cognitive impairment, unstable medical or cardiopulmonary disease, major lower‑limb deformity, or skin/soft‑tissue problems that prevent safe device use are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the orthosis could improve walking speed and stability, lower fall risk, and enhance daily mobility and quality of life for older adults with gait impairment.

How similar studies have performed: Similar soft exosuits and wearable knee supports have shown modest gait improvements in small studies, but this specific fabric orthosis with shape‑memory alloy is novel and largely untested in larger trials.

Eligibility criteria

Inclusion Criteria:

Eligibility for participation in the study requires that all the following criteria are met:

1. Age: Participants must be 65 years of age or older.
2. Comprehension and Compliance: Able to fully understand and comply with the instructions and study procedures.
3. 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).

Exclusion Criteria:

Individuals meeting any of the following criteria will be excluded from study participation:

1. Inability to Consent: Unable to provide informed consent or not willing to participate in the study procedures.
2. Severe Sensory or Motion Limitations: Including severe visual or vestibular impairments that could increase the risk of falling.
3. Communication Barriers: Significant hearing, speech, or language problems that would hinder communication with study personnel.
4. Independent Walking Inability: Cannot walk independently without the aid of a walking device.
5. Other Significant Diseases or Conditions:

   * Neurological disorders that affect walking ability (e.g., stroke, Parkinson's disease).
   * Orthopedic or musculoskeletal conditions severely affecting lower limb function.
   * Severe cardiovascular conditions including uncontrolled hypertension or heart failure.
   * Respiratory diseases requiring regular oxygen therapy.
   * Active cancer treatment or cancer treatment within the past 3 years (except basal cell carcinoma or localized prostate cancer).
   * Severe psychiatric disorders like schizophrenia or bipolar disorder.
6. Other Exclusionary Factors:

   * Past severe orthopedic surgeries on lower limbs which might affect gait and mobility.
   * Severe back pain or any other condition affecting mobility not already listed.

Where this trial is running

Seoul, Jongno

• Seoul National University Hospital — Seoul, Jongno, South Korea (Recruiting)

Study contacts

• Principal investigator: hyungik shin, prof — Seoul National University Hospital
• Study coordinator: JungHyun Kim, prof

Conditions Gait; Fall; Orthotic Devices; Geriatric patient