Vestibular Rehabilitation Exercise in Mild Traumatic Brain Injury

NCT ID: NCT06118541

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2023-06-17

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.

Conditions

Vestibular Rehabilitation

Study Design

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

Study Groups

Vestibular Rehabilitation therapy

The experimental group received a "vestibular rehabilitation exercise" program, 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

Group Type: EXPERIMENTAL

Vestibular Rehabilitation therapy

Intervention Type: BEHAVIORAL

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

standard care

Monitor the patient's consciousness and limb muscle strength, give drugs according to the time point of administration, and educate the importance of early getting out of bed

Group Type: EXPERIMENTAL

Vestibular Rehabilitation therapy

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hui-Chun Liao

Role: PRINCIPAL_INVESTIGATOR

National Taiwan Hospital Yunlin Branch

Pei-Yin Sun

Role: PRINCIPAL_INVESTIGATOR

National Taiwan Hospital Yunlin Branch

Locations

National Taiwan Universiyt Hospital Yunlin Branch

Yuanlin, , Taiwan

Countries

Taiwan

Other Identifiers

202203063RINB

Identifier Type: -

Identifier Source: org_study_id