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

Mild Traumatic Brain Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05638659
• Other study ID #: N202201026
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2022
• Est. completion date: July 2024

Study information

• Verified date: November 2022
• Source: Taipei Medical University
• Contact: Li-Fong Lin, Ph.D.
• Phone: +886-27361661
• Email: fong930[@]tmu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• Computerized dual-task balance and home program
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.
• Medical consultation and traditional balance training
Participants were assigned to read the health education flier and were assessed directly.

Locations

Country	Name	City	State
Taiwan	Taipei Medical University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	Gait analysis	The spatiotemporal gait parameters of asymmetry of the feet were measured with Physilog® system (Gait up Sàrl, Lausanne, Switzerland).	The end of intervention (assessments within one week)
Primary	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)
Secondary	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.	The end of intervention (assessments within one week)