Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement

NCT06387459 | Recruiting

• 1 other identifier: 2022M3C1A3090827
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gait; Fall; Orthotic Devices

Keywords

Geriatric patient

Outcome Measures

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.

  1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)

Secondary Outcomes (6)

• Dropout Rate

  1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)

• User Feedback

  1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)

• 6-Minute Walk Test

  1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)

• 10-Meter Walk Test

  1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)

• Surface Electromyography

  1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)

Study Arms (1)

Knee Extensor Muscle-Mimicking Orthosis

EXPERIMENTAL

This arm involves participants wearing a novel, lightweight fabric-type orthosis designed to mimic the function of knee extensor muscles through embedded shape-memory alloys. This intervention aims to support the knee joint during gait, enhancing stability and mobility for elderly individuals with compromised muscle function.

Device: Fabric-Type Knee Extensor Muscle-Mimicking Orthosis

Interventions

Fabric-Type Knee Extensor Muscle-Mimicking Orthosis DEVICE

The 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.

Knee Extensor Muscle-Mimicking Orthosis

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Science and ICT, Republic of Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno, 03080, South Korea

RECRUITING

Study Officials

• hyungik shin, prof

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• Woo Hyung Lee, prof

  Seoul National University Hospital

  STUDY DIRECTOR

• Jung hyun Kim, prof

  Seoul National University Hospital

  STUDY DIRECTOR

Central Study Contacts

JungHyun Kim, prof

CONTACT

82+1088632341; kiking0@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 29, 2024
• Study Start: July 31, 2024
• Primary Completion: July 30, 2025
• Study Completion (Estimated): May 14, 2026
• Last Updated: June 11, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)