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GaitNCT06387459

Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement

A study testing Fabric-Type Knee Extensor Muscle-Mimicking Orthosis in people with Gait and Fall, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Gait, Fall, Orthotic Devices
What is being tested?
Fabric-Type Knee Extensor Muscle-Mimicking Orthosis
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
31 Jul 2024to 14 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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:
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  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

JungHyun Kim, prof contact

82+1088632341

kiking0@naver.com

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, Jongno, 03080

    junghyun kim, Ph. D., 82+1059657182, kiking0@naver.com

    Recruiting

Other trials in South Korea

About this study

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

Read the detailed 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)
  • Walking environment will include EMG (Electromyography) measurements, 6-minute walk test, 10-meter walk test, and comprehensive gait analysis using platforms like the GAITRite system.
  • Seating environment will include EMG (Electromyography) measurements and TUG test. 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
Being tested
Fabric-Type Knee Extensor Muscle-Mimicking Orthosis
Keywords
Geriatric patient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fabric-Type Knee Extensor Muscle-Mimicking OrthosisDevice

    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.

Study groups in NCT06387459
Study groupRoleWhat they receive
Knee Extensor Muscle-Mimicking OrthosisExperimentalThis 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.
Receives: Device: Fabric-Type Knee Extensor Muscle-Mimicking Orthosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (6)

  1. Dropout Rate

    Measures participant retention throughout the study, providing insights into the orthosis's usability and participant satisfaction.

    Measured: 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.

    Measured: 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.

    Measured: 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.

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

  5. Surface Electromyography

    To evaluate muscle activity patterns that indicate the orthosis's impact on muscle engagement during gait and sit to stand.

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

  6. Gait Analysis

    Using tools like the GAITRite system to obtain detailed measurements of gait cycle characteristics, providing comprehensive insights into the functional improvements afforded by the orthosis.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2024
  2. Study start31 Jul 2024
  3. Primary completion30 Jul 2025 (estimated)
  4. Study completion14 May 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06387459
Sponsor's protocol ID
2022M3C1A3090827
Status last verified
Jul 2024
First submitted
22 Apr 2024
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Fabric-Type Knee Extensor Muscle-Mimicking Orthosis in people with Gait and Fall, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact JungHyun Kim, prof (82+1088632341, kiking0@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion Rate (time frame: 1.Baseline (before brace application) 2.Immediately post-brace application (power off), 3.Immediately post-brace activation (power on)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06387459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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