Feasibility of Fabric Orthosis for Knee Support in Elderly Gait Improvement

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Apr 25, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new fabric support device, called an orthosis, designed to help older adults walk better and feel more stable. The trial will include 30 participants aged 65 and older who have conditions that make it hard for them to move around, like muscle weakness, diabetes, or knee arthritis. The goal is to see if this orthosis can improve their walking speed and balance, potentially reducing the risk of falls and enhancing their overall quality of life.

To join the study, participants need to be 65 or older and have at least one of the mobility-impacting conditions mentioned. They should also be able to understand and follow instructions during the trial. Those who have serious health issues that could affect their ability to walk or communicate, or who can't walk on their own, will not be eligible. Participants will wear the orthosis during several sessions while researchers observe their walking in different situations to understand how well the device works. This study is not yet recruiting participants, but it aims to provide valuable insights into how this new support device can help improve mobility in elderly individuals.

Gender

ALL

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.