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Elucidate the Mechanisms, Development and Effectiveness of Balance Control and Gait Strategy After Mild Traumatic Brain Injury: Develop Innovative Design of Computerized Dual-task Balance Module

Primary Purpose

Mild Traumatic Brain Injury

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Computerized dual-task balance and home program
Medical consultation and traditional balance training
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mild Traumatic Brain Injury

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age: 20-80 years old. Patients with mild traumatic brain injury: According to the American Congress of Rehabilitation Medicine, the loss of consciousness is less than 30 minutes, the coma index is 13-15, and the post-traumatic amnesia is less than 24 hours. Healthy patients: healthy subjects without any neurological, psychiatric, or severe musculoskeletal medical history. Regardless of gender. Exclusion Criteria: Mild traumatic brain injury: moderate to severe brain injury, epilepsy, history of cardiovascular disease, lack of intelligence, neurodegenerative diseases, history of head trauma, systemic diseases, left-handedness, and use of psychotropic drugs. Healthy subjects: any neurological, psychiatric, severe musculoskeletal medical history.

Sites / Locations

  • Taipei Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Twice a week for 8 weeks, total of 16 sessions course of computerized dual-task balance and home program.

Medical consultation and traditional balance training, and assessed after 8 weeks.

Outcomes

Primary Outcome Measures

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
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).
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).
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).
Gait analysis
The spatiotemporal gait parameters of asymmetry of the feet were measured with Physilog® system (Gait up Sàrl, Lausanne, Switzerland).
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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 13, 2022
Last Updated
November 27, 2022
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05638659
Brief Title
Elucidate the Mechanisms, Development and Effectiveness of Balance Control and Gait Strategy After Mild Traumatic Brain Injury: Develop Innovative Design of Computerized Dual-task Balance Module
Official Title
Elucidate the Mechanisms, Development and Effectiveness of Balance Control and Gait Strategy After Mild Traumatic Brain Injury: Develop Innovative Design of Computerized Dual-task Balance Module
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Twice a week for 8 weeks, total of 16 sessions course of computerized dual-task balance and home program.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Medical consultation and traditional balance training, and assessed after 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Computerized dual-task balance and home program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Medical consultation and traditional balance training
Intervention Description
Participants were assigned to read the health education flier and were assessed directly.
Primary Outcome Measure Information:
Title
Balance test
Description
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
Time Frame
The end of intervention (assessments within one week)
Title
Balance of sensory-integration test
Description
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).
Time Frame
The end of intervention (assessments within one week)
Title
Balance of postural-stability test
Description
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).
Time Frame
The end of intervention (assessments within one week)
Title
Modified clinical test of sensory integration and balance (mCTSIB)
Description
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).
Time Frame
The end of intervention (assessments within one week)
Title
Gait analysis
Description
The spatiotemporal gait parameters of asymmetry of the feet were measured with Physilog® system (Gait up Sàrl, Lausanne, Switzerland).
Time Frame
The end of intervention (assessments within one week)
Title
Vestibular function test - oculomotor system
Description
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.
Time Frame
The end of intervention (assessments within one week)
Secondary Outcome Measure Information:
Title
Biomarker
Description
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.
Time Frame
The end of intervention (assessments within one week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age: 20-80 years old. Patients with mild traumatic brain injury: According to the American Congress of Rehabilitation Medicine, the loss of consciousness is less than 30 minutes, the coma index is 13-15, and the post-traumatic amnesia is less than 24 hours. Healthy patients: healthy subjects without any neurological, psychiatric, or severe musculoskeletal medical history. Regardless of gender. Exclusion Criteria: Mild traumatic brain injury: moderate to severe brain injury, epilepsy, history of cardiovascular disease, lack of intelligence, neurodegenerative diseases, history of head trauma, systemic diseases, left-handedness, and use of psychotropic drugs. Healthy subjects: any neurological, psychiatric, severe musculoskeletal medical history.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li-Fong Lin, Ph.D.
Phone
+886-27361661
Ext
3618
Email
fong930@tmu.edu.tw
Facility Information:
Facility Name
Taipei Medical University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Elucidate the Mechanisms, Development and Effectiveness of Balance Control and Gait Strategy After Mild Traumatic Brain Injury: Develop Innovative Design of Computerized Dual-task Balance Module

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