Menu
Not yet recruiting NCT07017504

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

No phase Interventional Balance Fall Prevention Orthotic Device

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: proprioception-enhancing assistive orthosis.
Who it may be relevant to
Registry conditions: Balance, Fall Prevention, Orthotic Device. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • Postural Sway [Time frame: up to 2 weeks]
Secondary outcome measures (5)
  • Berg Balance Scale [Time frame: up to 2 weeks]
  • Romberg Test [Time frame: up to 2 weeks]
  • Passive Joint Position Reproduction Test (Passive JPR) [Time frame: up to 4 weeks]
  • Active Joint Position Reproduction Test (Active JPR) [Time frame: up to 4 weeks]
  • Threshold to Detection of Passive Motion (TTDPM) [Time frame: up to 4 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

South Korea · 1 center
  • Seoul National University Hospital — Seoul

Identifiers

NCT: NCT07017504 · 0720253096_1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗