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

Официальное название

The Effects of a Proprioception-enhancing Assistive Orthosis on Balance and Joint Sense in Geriatric Patients

Обзор

This study investigates the effects of a proprioception-enhancing assistive orthosis on balance and joint sense in geriatric patients with age-related diseases. The study uses wearable devices that deliver vibration stimuli to improve proprioceptive feedback. A total of 20 participants will be enrolled in a 24-month, IRB-approved trial at Seoul National University Hospital. The study assesses functional balance and joint position sense before and after using the device.

Вмешательства

• Устройство proprioception-enhancing assistive orthosis
  A wearable device that provides mechanical vibration to the tendons around the knee and ankle to enhance proprioceptive feedback. Vibration intensity and timing are controlled automatically based on body tilt measured by an IMU sensor. The device is applied during balance and joint sense assessments conducted across three visits.

Первичные конечные точки

• Postural Sway [Срок оценки: up to 2 weeks]

Вторичные конечные точки (5)

• Berg Balance Scale [Срок оценки: up to 2 weeks]
• Romberg Test [Срок оценки: up to 2 weeks]
• Passive Joint Position Reproduction Test (Passive JPR) [Срок оценки: up to 4 weeks]
• Active Joint Position Reproduction Test (Active JPR) [Срок оценки: up to 4 weeks]
• Threshold to Detection of Passive Motion (TTDPM) [Срок оценки: up to 4 weeks]

Критерии участия

Критерии включения

• 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)
• Able to fully understand and follow instructions related to walking, sitting, and balance.

Критерии исключения

• Unable or unwilling to provide informed consent
• High risk of falls due to severe visual impairment or dizziness
• Communication difficulties due to speech, language, or hearing problems
• Inability to walk independently without assistive devices
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

South Korea · 1 центр

• Seoul National University Hospital — Seoul

Идентификаторы

NCT: NCT07017504 · 0720253096_1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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