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

Seoul National University

Status: Begins enrollment this month

Conditions: Balance; Orthotic Device; Fall Prevention

Treatments: Device: proprioception-enhancing assistive orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT07017504

0720253096_1

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Proprioception-Enhancing Orthosis

Experimental group

Description:

Geriatric patients with age-related diseases will undergo three assessment phases: (1) without the orthosis, (2) with the orthosis worn but vibration inactive, and (3) with the orthosis worn and vibration active.

Treatment:

Device: proprioception-enhancing assistive orthosis