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Search / Trial NCT07017504

THE EFFECTS OF A PROPRIOCEPTION-ENHANCING ASSISTIVE ORTHOSIS ON BALANCE AND JOINT SENSE IN GERIATRIC PATIENTS

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Jun 3, 2025

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how a special device, called a proprioception-enhancing assistive orthosis, can help improve balance and the ability to sense joint position in older adults who have age-related health issues. The device uses gentle vibrations to enhance feedback from the body, which may help participants maintain their balance better and prevent falls. The study will involve 20 older adults and will take place over 24 months at Seoul National University Hospital.

To participate, individuals need to have certain age-related conditions that affect their balance and muscle strength. Key eligibility criteria include having low handgrip strength or poor performance in a physical abilities test. Participants should be able to understand instructions related to walking and balance. However, those with serious vision problems, severe dizziness, or certain medical conditions that make walking difficult will not be eligible. Throughout the trial, participants will be assessed on their balance and joint position sense before and after using the device, helping researchers understand its effectiveness in promoting safety and mobility among older adults.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Patients with age-related diseases affecting balance and joint sense, who meet two or more of the following criteria for sarcopenia:
  • Muscle strength: Handgrip strength \< 28 kg (men), \< 18 kg (women)
  • Physical performance: Short Physical Performance Battery (SPPB) ≤ 8 points
  • Muscle mass: Bioimpedance analysis showing \< 7.0 kg/m² (men), \< 5.7 kg/m² (women)
  • 2. Able to fully understand and follow instructions related to walking, sitting, and balance.
  • Exclusion Criteria:
  • 1. Unable or unwilling to provide informed consent
  • 2. High risk of falls due to severe visual impairment or dizziness
  • 3. Communication difficulties due to speech, language, or hearing problems
  • 4. Inability to walk independently without assistive devices
  • 5. History of diseases affecting gait, efficiency, or endurance, such as:
  • Neurological disorders (e.g., stroke, Parkinson's disease)
  • Musculoskeletal disorders affecting the lower limbs
  • History of major orthopedic surgery on the lower limbs
  • Severe back pain or musculoskeletal pain affecting gait
  • Cardiovascular disease including heart failure or uncontrolled hypertension
  • Pulmonary diseases requiring regular oxygen therapy
  • Cancer requiring treatment within the past 3 years (except for non-melanoma skin cancer or early-stage breast/prostate cancer)
  • Psychiatric disorders such as schizophrenia, other psychoses, or bipolar disorder
  • Any other disease that significantly limits mobility

About Seoul National University Hospital

Seoul National University Hospital (SNUH) is a leading medical institution in South Korea, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent clinical trial sponsor, SNUH integrates cutting-edge scientific inquiry with patient-centered care, facilitating the development of novel therapies and treatment protocols. The hospital boasts a diverse range of specialized departments and a robust infrastructure for conducting clinical studies, ensuring rigorous adherence to ethical standards and regulatory compliance. By fostering collaboration among multidisciplinary teams, SNUH aims to contribute significantly to global medical advancements and improve patient outcomes.

Locations

Seoul, Jongno, Korea, Republic Of

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported