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The purpose of this study is to innovatively design and develop computerized dual-task balance training modules and home modules, and conduct proactive clinical verification to focus on the effectiveness of balance control and gait stabilization strategies. It is expected that in addition to the development of the training module, a proactive study will be conducted at the same time. During the period from the fourth quarter of the first year to the second year, there will be 25 patients in the experimental group and 25 patients in the control group. A total of 50 patients will undergo preliminary efficacy analysis.
After mild traumatic brain injury (mTBI), patients often complain of dizziness, balance disturbances, and gait instability. On average, dizziness accounts for about 23 to 81%, and dizziness symptoms persist from 1.2% 6 months after the injury. Between 32.5% in 5 years. In the past, in the process of neuron regeneration and repair after mild traumatic brain injury, it was found that vestibular function and biomarkers may be related to balance restoration and treatment. It is necessary to conduct further research to explain its potential mechanism and clinical significance. In addition, balance training after mTBI can accelerate dizziness recovery, balance control and gait stability, but the effect lasts for a limited time. The development of a dual-task balance training module can extend the recovery time, this project needs to be discussed in depth. This project mainly explores the influence of balance control and gait strategies after mTBI, linking vestibular function and biomarkers; innovative design and development of computerized dual-task balance training and home modules; combined with computerized dual-task balance training modules can accelerate the recovery of dizziness, balance control and gait stability after injury.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Twice a week for 8 weeks, total of 16 sessions course of computerized dual-task balance and home program. |
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| Control group | Active Comparator | Medical consultation and traditional balance training, and assessed after 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized dual-task balance and home program | Behavioral | Portable force plate with aluminum top plate for measuring ground reaction forces, moments and the center of pressure in biomechanics. Through software to collect data from the force plates, converts the trials into useful information and plots the results. The force plates and charge amplifiers are fully remote controlled by software thus making the system extremely flexible and easy to use. |
| Measure | Description | Time Frame |
|---|---|---|
| Balance test | Berg Balance Scale (BBS), which rated performance from 0 (cannot perform) to 4(normal performance) on 14 different tasks, including ability to sit, stand, reach, lean over, turn and look over each shoulder, turn in a complete circle and step. The total possible score is 56, indicating excellent balance. A score of 0 to 20 indicates a high risk, 21 40 indicates a medium risk, and 41 56 indicates a low risk of falling. indicates a low risk of falling. Balance Error Scoring System (BESS) test Balance Error Scoring System (BESS) test | The end of intervention (assessments within one week) |
| Balance of sensory-integration test | The balance of postural-stability test and the modified clinical test of sensory integration and balance (mCTSIB) were performed using the Biodex Stability System (BSS; Biodex Medical Systems, Shirley, NY, USA). | The end of intervention (assessments within one week) |
| Balance of postural-stability test | The balance of postural stability was tested according to 3 stability indices (overall stability, OA; anterior-to-posterior stability, AP; and medial-to-lateral stability, ML). | The end of intervention (assessments within one week) |
| Modified clinical test of sensory integration and balance (mCTSIB) | The mCTSIB, which includes 4 sway indices, was conducted 4 sensory conditions: (1) eyes open whilst standing on a firm surface (EOFIS); (2) eyes closed whilst standing on a firm surface (ECFIS); (3) eyes open whilst standing on an unstable (foam) surface (EOFOS); and (4) eyes closed whilst standing on an unstable (foam) surface (ECFOS). | The end of intervention (assessments within one week) |
| Gait analysis | The spatiotemporal gait parameters of asymmetry of the feet were measured with Physilog® system (Gait up Sà rl, Lausanne, Switzerland). |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarker | Sera were assessed for for anti-bone marrow X kinase (anti-BMX, or cytoplasmic tyrosine-protein kinase) antibodies using using a commercial enzyme-linked immunosorbent assay (ELISA) kit with a range of 1.56 g/L according to the manufacturer's instructions. Results were determined by the optical density of each well, using the microplate reader Infinite 200 measured at 450 nm. A standard curve was made by reducing the data using the computer software Magellan capable of generating a four-parameter logistic (4-PL) curve-fit and calculating the sample concentrations. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li-Fong Lin, Ph.D. | Contact | +886-27361661 | 3618 | fong930@tmu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University Hospital | Recruiting | Taipei | Taiwan |
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| Medical consultation and traditional balance training | Behavioral | Participants were assigned to read the health education flier and were assessed directly. |
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| The end of intervention (assessments within one week) |
| Vestibular function test - oculomotor system | Use smooth pursuit eye movements (SPEMs) to obtain baseline data. The examiner evaluates SPEMs by subjectively noting their accuracy in relation to a target that is being moved manually to nine directions. At the same time, the patient follows it with his or her eyes. | The end of intervention (assessments within one week) |
| The end of intervention (assessments within one week) |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
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