NCT06118541

Vestibular Rehabilitation Exercise in Mild Traumatic Brain Injury

To Investigate the Effects of Vestibular Rehabilitation Exercise on Dizziness, Body Balance, Post Concussion Syndrome, Anxiety and Quality of Life in Patients With Mild Traumatic Brain Injury

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

Traumatic brain injury (TBI) is a leading cause of long-term disability and mortality. The costs associated with hospitalization, rehabilitation, and productivity losses after injury impose a significant socioeconomic and healthcare burden. TBI patients often struggle with symptoms such as dizziness and post-concussion syndrome, preventing them from returning to their previous level of functioning. This leads to negative consequences, including unemployment, psychosocial adjustment difficulties, and decreased quality of life, particularly affecting young working-age individuals. The purpose of this study was to investigate whether vestibular rehabilitation exercises for mild traumatic brain injury (mTBI) patients could improve symptoms of dizziness, post-concussion syndrome, physical balance, anxiety, and quality of life. The study aimed to provide individualized care plans for mTBI patients, reducing symptom burden, lowering healthcare costs, and enhancing their quality of life.

Detailed description

This research employed a single-blind randomized clinical trial design. Participants were recruited from a teaching hospital in the central region of Taiwan, including patients from the neurosurgery ward, emergency department, and outpatient clinics. The experimental group received a "vestibular rehabilitation exercise" program, while the control group received "standard care." The assessment tools used in this study included the Chinese version of the Dizziness Handicap Inventory (DHI), Dizziness Visual Analog Scale (DVAS), 16-item Post-Concussion Symptom Checklist (PCSC), Beck Anxiety Inventory (BAI), Traumatic Brain Injury Quality of Life (TBI-QOL) questionnaire, and a standing balance test. Measurements were taken at baseline and at weeks 2, 4, 8, and 12 post-intervention. Data analysis included descriptive statistics and inferential statistics, such as independent sample t-tests, chi-square tests, Pearson's correlation coefficient, Fisher's exact test, and generalized estimating equations. A total of 70 mTBI patients were enrolled in this study, with an average age of 54.40 (±20.43) years. The majority were male (62.80%), and the average time from injury to vestibular rehabilitation exercise initiation was 2.4 days. The two groups did not differ significantly in terms of age, gender, employment status, economic status, marital status, TBI history, cause of injury, or chronic illnesses (p \> 0.05), except for education level (p = 0.005). There were no significant differences in the DHI, DVAS, immediate standing balance test, and PCSC scores between the two groups (p \> 0.05) at baseline. However, significant differences were observed in anxiety levels (p = 0.032) and quality of life (p = 0.030). Results revealed the following: Dizziness: Both groups showed significant improvements in DHI and DVAS scores over time (p \< 0.001), indicating that dizziness symptoms gradually improved. The experimental group demonstrated significantly better improvements in DHI and DVAS scores at weeks 2, 4, and 8 (p \< 0.05), suggesting that vestibular rehabilitation exercises were more effective in reducing dizziness symptoms compared to standard care. Post-Concussion Syndrome: Both groups exhibited significant reductions in PCSC scores over time (p \< 0.001), indicating gradual improvement in post-concussion symptoms. However, the experimental group showed a significant group and time interaction effect at week 4 (p = 0.033), indicating better improvement in post-concussion syndrome symptoms compared to the control group. Physical Balance: Both groups demonstrated significant improvements in standing balance (standing time) over time (p \< 0.001). The experimental group exhibited significant group and time interaction effects at weeks 4, 8, and 12 (p \< 0.01), indicating better improvement in physical balance (increased standing time) compared to the control group. Quality of Life: Both groups showed significant improvements in quality of life scores over time (p \< 0.001). The experimental group exhibited significant group and time interaction effects at weeks 4, 8, and 12 (p \< 0.001), indicating better improvement in quality of life compared to the control group. Anxiety: Both groups demonstrated significant reductions in anxiety scores over time (p \< 0.001). The experimental group exhibited significant group and time interaction effects at weeks 2, 4, 8, and 12 (p \< 0.01), indicating greater reduction in anxiety symptoms compared to the control group. In conclusion, vestibular rehabilitation exercises can reduce dizziness, alleviate post-concussion syndrome, improve physical balance, reduce anxiety, and enhance the quality of life in mTBI patients. It is recommended to extend the implementation of these exercises to other hospitals to benefit patients with similar symptoms.

Conditions

• Vestibular Rehabilitation

Interventions

Type	Name	Description
BEHAVIORAL	Vestibular Rehabilitation therapy	Vestibular rehabilitation exercises of 30 to 60 minutes twice a week for eight weeks Vestibular rehabilitation exercise program: 1. Eye-Head Coordination exercise 2. Sitting balance exercises 3. Standing Static balance exercises 4. Standing Dynamic balance exercises 5. Ambulation exercises

Timeline

• Start date: 2022-05-20
• Primary completion: 2023-06-17
• Completion: 2023-06-17
• First posted: 2023-11-07
• Last updated: 2023-11-07

Locations

1 site across 1 country: Taiwan