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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorSeoul National University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Proprioception-Enhancing OrthosisExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
up to 2 weeks

Secondary outcomes

1

Berg Balance Scale

The Berg Balance Scale (BBS) is a 14-item objective measure used to assess static balance and fall risk in adults. Each item is scored on a scale from 0 to 4, with 0 indicating the lowest level of function and 4 indicating the highest level. The total score ranges from 0 to 56, with higher scores indicating better balance performance. 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.

Time frame
up to 2 weeks
2

Romberg Test

The Romberg Test is a neurological test used to assess balance and proprioceptive control. Participants are asked to stand with their feet together, arms at their sides, and eyes closed, while the examiner observes for excessive sway or loss of balance. The duration for which the participant can maintain the position without stepping or falling is recorded, up to a maximum of 60 seconds. Longer durations indicate better balance. 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.

Time frame
up to 2 weeks
3

Passive Joint Position Reproduction Test (Passive JPR)

Assesses proprioceptive accuracy by passively moving a joint (e.g., the knee) to a target angle, then asking the participant to indicate when the position is reached again. The difference between target and reproduced angles reflects proprioceptive acuity. 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.

Time frame
up to 4 weeks
4

Active Joint Position Reproduction Test (Active JPR)

Participants actively move their joint to a memorized target angle without visual or auditory cues. The accuracy of the reproduced angle is used to evaluate active proprioceptive control. 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.

Time frame
up to 4 weeks

Other outcomes

Sponsors and contacts

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Seoul National University Hospital

Lead sponsor

Ministry of Science and ICT, Republic of Korea

Collaborator

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