Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2025-12-24 @ 2:55 PM
NCT ID:
NCT06387459
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06387459
Study Brief:
Protocol Section:
NCT06387459