THE EFFECTS OF A PROPRIOCEPTION-ENHANCING ASSISTIVE ORTHOSIS ON BALANCE AND JOINT SENSE IN GERIATRIC PATIENTS
NCT ID: NCT07017504
Last Updated: 2025-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-07-01
2027-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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)
2. Able to fully understand and follow instructions related to walking, sitting, and balance.
Exclusion Criteria
2. High risk of falls due to severe visual impairment or dizziness
3. Communication difficulties due to speech, language, or hearing problems
4. Inability to walk independently without assistive devices
5. 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
65 Years
ALL
No
Sponsors
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Ministry of Science and ICT, Republic of Korea
OTHER_GOV
Seoul National University Hospital
OTHER
Responsible Party
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Locations
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Seoul National University Hospital
Seoul, Jongno, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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0720253096_1
Identifier Type: -
Identifier Source: org_study_id
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