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New treatment option for Gait
Official title Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement
ClinicalTrials.gov ID: NCT06387459
What this study is testing
- What it's testing
- 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 plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join 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.
You likely can't join 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:
See the full eligibility criteria
- 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).
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Jongno, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Jongno, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.