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

NCT07017504 | Not Yet Recruiting

• 1 other identifier: 0720253096_1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Balance; Fall Prevention; Orthotic Device

Outcome Measures

Primary Outcomes (1)

• Postural Sway

  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.

  up to 2 weeks

Secondary Outcomes (5)

• 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

Study Arms (1)

Proprioception-Enhancing Orthosis

EXPERIMENTAL

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.

Device: proprioception-enhancing assistive orthosis

Interventions

proprioception-enhancing assistive orthosis DEVICE

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.

Proprioception-Enhancing Orthosis

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Ministry of Science and ICT, Republic of Korea: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno, South Korea

Location

Central Study Contacts

JungHyun Kim, prof

CONTACT

82+1088632341; kiking0@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2025
• First Posted: June 12, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)