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

NCT ID: NCT05638659

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-16
• Study Completion Date: 2024-07-31

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.

Conditions

Mild Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Computerized dual-task balance and home program

Intervention Type: 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.

Control group

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

Group Type: ACTIVE_COMPARATOR

Medical consultation and traditional balance training

Intervention Type: BEHAVIORAL

Participants were assigned to read the health education flier and were assessed directly.

Interventions

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.

Intervention Type: BEHAVIORAL

Medical consultation and traditional balance training

Participants were assigned to read the health education flier and were assessed directly.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taipei Medical University

OTHER

Sponsor Role: lead

Responsible Party

Li-Fong Lin

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Taipei Medical University Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Li-Fong Lin, Ph.D.

Role: CONTACT

fong930@tmu.edu.tw

+886-27361661 ext. 3618

Other Identifiers

N202201026

Identifier Type: -

Identifier Source: org_study_id