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

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2027-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Balance Fall Prevention Orthotic Device

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

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.

Group Type EXPERIMENTAL

proprioception-enhancing assistive orthosis

Intervention Type 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.

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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)
2. Able to fully understand and follow instructions related to walking, sitting, and balance.

Exclusion Criteria

1. Unable or unwilling to provide informed consent
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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Science and ICT, Republic of Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Seoul National University Hospital

Seoul, Jongno, South Korea

Site Status

Countries

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South Korea

Central Contacts

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JungHyun Kim, prof

Role: CONTACT

82+1088632341

Facility Contacts

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junghyun kim

Role: primary

82+1059657182

Other Identifiers

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0720253096_1

Identifier Type: -

Identifier Source: org_study_id

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