The Effects of a Proprioception-enhancing Assistive Orthosis on Balance and Joint Sense in Geriatric Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Postural Sway
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
Proprioception-Enhancing Orthosis
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.
Intervention: proprioception-enhancing assistive orthosis (Device)
Outcomes
Primary Outcomes
Postural Sway
Time Frame: up to 2 weeks
This measures the amount of body sway during quiet standing (static) or controlled leaning in various directions (dynamic). Parameters such as center of pressure (COP) displacement, velocity, and area are recorded to assess balance stability. Assessments will be conducted under the following three conditions: 1. without the orthosis, 2. with the orthosis worn but vibration inactive, and 3. with the orthosis worn and vibration active.
Secondary Outcomes
- Berg Balance Scale(up to 2 weeks)
- Romberg Test(up to 2 weeks)
- Passive Joint Position Reproduction Test (Passive JPR)(up to 4 weeks)
- Active Joint Position Reproduction Test (Active JPR)(up to 4 weeks)
- Threshold to Detection of Passive Motion (TTDPM)(up to 4 weeks)