BalanceNCT07017504
THE EFFECTS OF A PROPRIOCEPTION-ENHANCING ASSISTIVE ORTHOSIS ON BALANCE AND JOINT SENSE IN GERIATRIC PATIENTS
A study testing proprioception-enhancing assistive orthosis in people with Balance and Fall Prevention, run by Seoul National University Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Balance, Fall Prevention, Orthotic Device
- What is being tested?
- proprioception-enhancing assistive orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 14Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno
junghyun kim, 82+1059657182, kiking0@naver.com
About this study
Official title: The Effects of a Proprioception-enhancing Assistive Orthosis on Balance and Joint Sense in Geriatric Patients
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
- Being tested
- proprioception-enhancing assistive orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proprioception-enhancing assistive orthosisDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: proprioception-enhancing assistive orthosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- without the orthosis,
- with the orthosis worn but vibration inactive, and
- with the orthosis worn and vibration active.
Measured: up to 2 weeks
Secondary outcomes (5)
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:
- without the orthosis,
- with the orthosis worn but vibration inactive, and
- with the orthosis worn and vibration active.
Measured: up to 2 weeks
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:
- without the orthosis,
- with the orthosis worn but vibration inactive, and
- with the orthosis worn and vibration active.
Measured: up to 2 weeks
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:
- without the orthosis,
- with the orthosis worn but vibration inactive, and
- with the orthosis worn and vibration active.
Measured: up to 4 weeks
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:
- without the orthosis,
- with the orthosis worn but vibration inactive, and
- with the orthosis worn and vibration active.
Measured: up to 4 weeks
Threshold to Detection of Passive Motion (TTDPM)
Measures the smallest joint movement that a participant can detect while the joint is passively moved at a very slow, constant speed. This tests the sensitivity of proprioceptive input.
Assessments will be conducted under the following three conditions:
- without the orthosis,
- with the orthosis worn but vibration inactive, and
- with the orthosis worn and vibration active.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BalanceStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017504
- Sponsor's protocol ID
- 0720253096_1
- Status last verified
- May 2025
- First submitted
- 30 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Proprioception-enhancing Assistive Orthosis on Balance and Joint Sense in Geriatric Patients
- ClinicalTrials.gov ID
- NCT07017504
- Acronym / sponsor ID
- 0720253096_1
- Conditions
- Balance, Fall Prevention, Orthotic Device
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and ICT, Republic of Korea
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 12 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proprioception-Enhancing Orthosis | Experimental | Device: proprioception-enhancing assistive orthosisGeriatric 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients with age-related diseases affecting balance and joint sense, who meet two or more of the following criteria for sarcopenia:
- Able to fully understand and follow instructions related to walking, sitting, and balance.
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| proprioception-enhancing assistive orthosisA 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. | Device | Proprioception-Enhancing Orthosis |
Primary outcome
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.
5 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing proprioception-enhancing assistive orthosis in people with Balance and Fall Prevention, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JungHyun Kim, prof (82+1088632341, kiking0@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postural Sway (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.