Clinical trial NCT07017504: THE EFFECTS OF A PROPRIOCEPTION-ENHANCING ASSISTIVE ORTHOSIS ON BALANCE AND JOINT SENSE IN GERIATRIC PATIENTS
Official title: The Effects of a Proprioception-enhancing Assistive Orthosis on Balance and Joint Sense in Geriatric Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Balance
Fall Prevention
Orthotic Device
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and ICT, Republic of Korea
First posted: 2025-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


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

Primary outcomes:
measure: Postural Sway
timeFrame: up to 2 weeks
Secondary outcomes:
measure: Berg Balance Scale
timeFrame: up to 2 weeks
measure: Romberg Test
timeFrame: up to 2 weeks
measure: Passive Joint Position Reproduction Test (Passive JPR)
timeFrame: up to 4 weeks
measure: Active Joint Position Reproduction Test (Active JPR)
timeFrame: up to 4 weeks
measure: Threshold to Detection of Passive Motion (TTDPM)
timeFrame: up to 4 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno
Study officials:
References: