Clinical trial NCT06118541: Vestibular Rehabilitation Exercise in Mild Traumatic Brain Injury
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vestibular Rehabilitation
Keywords: Traumatic Brain Injury
Vestibular Rehabilitation therapy
Dizziness
Quality of Life
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Within 2 weeks of diagnosis of mild head trauma (mild TBI, mTBI).
2. Adults over 20 years old
3. Coma Index (GCS) ≧ 13 points in the emergency department
4. Those who have three or more symptoms using the concussion syndrome checklist
5. No visual or hearing impairment
6. No fractures, no movement, mental illness and central related diseases
7. No cognitive impairment 8. Agree to participate in this study

Exclusion Criteria:

1. Patients with mental disorders and cognitive dysfunction
2. Those who relied on others for assistance in daily living activities prior to injury
3. Patients who have been diagnosed with inner ear disease causing balance problems
4. Patients who have been diagnosed with anxiety disorders before the injury

Primary outcomes:
measure: Dizziness Handicap Inventory (DHI)
timeFrame: The measurement time points were the time of receipt and the 2nd, 4th, 8th, and 12th weeks after intervention
measure: Dizziness Visual Analog Scale (DVAS)
timeFrame: The measurement time points were the time of receipt and the 2nd, 4th, 8th, and 12th weeks after intervention
measure: The 5 times sit to stand test(FTSTS)
timeFrame: The measurement time points were the time of receipt and the 4th, 8th, and 12th weeks after intervention
measure: 16-item Post-Concussion Symptom Checklist (PCSC)
timeFrame: The measurement time points were the time of receipt and the 2nd, 4th, 8th, and 12th weeks after intervention
measure: Beck Anxiety Inventory(BAI)
timeFrame: The measurement time points were the time of receipt and the 2nd, 4th, 8th, and 12th weeks after intervention
measure: Quality of Life after Brain Injury(QOLIBRI)
timeFrame: The measurement time points were the time of receipt and the 4th, 8th, and 12th weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Yuanlin
country: Taiwan
facility: National Taiwan Universiyt Hospital Yunlin Branch
Study officials:
affiliation: National Taiwan Hospital Yunlin Branch
name: Hui-Chun Liao
role: PRINCIPAL_INVESTIGATOR
affiliation: National Taiwan Hospital Yunlin Branch
name: Pei-Yin Sun
role: PRINCIPAL_INVESTIGATOR
References: