Vestibular Rehabilitation Exercise in Mild Traumatic Brain Injury

NCT06118541 | Completed DMC

• 1 other identifier: 202203063RINB
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Vestibular Rehabilitation

Keywords

Traumatic Brain Injury; Vestibular Rehabilitation therapy; Dizziness; Quality of Life

Outcome Measures

Primary Outcomes (6)

• Dizziness Handicap Inventory (DHI)

  The self-perception impairment of vestibular system disorders is assessed into three categories, representing "dizziness and unstable functioning", "emotional" and "physical", with a "yes", "no" or "sometimes" response to each item scoring 4 points; 2 points for responding to "sometimes"; and response "no" 0 points. The total score ranges from 0 (accessibility) to 100 (maximum score), with a total score between 0 and 50 indicating occasional dizziness, 51 to 60 indicating frequent dizziness and 61 to 100 indicating persistent dizziness

  The measurement time points were the time of receipt and the 2nd, 4th, 8th, and 12th weeks after intervention

• Dizziness Visual Analog Scale (DVAS)

  Draw a 100mm straight line, 0 cm on the far left, 10 cm on the far right, 0 means no dizziness, 10 means the dizziness is very severe, if the score is between 1-4 cm means mild dizziness, 4-8 cm means moderate dizziness, and between 8-10 cm is severe dizziness, take a pen and ask the patient to draw an X vertically on this straight line, representing the degree of his dizziness, and then use a ruler to measure the value and record it

  The measurement time points were the time of receipt and the 2nd, 4th, 8th, and 12th weeks after intervention

• The 5 times sit to stand test(FTSTS)

  The patient is asked to be able to sit independently in a chair without armrests, with his hands crossed over his chest, to stand and sit down 5 times as soon as possible, and to record the time of completion

  The measurement time points were the time of receipt and the 4th, 8th, and 12th weeks after intervention

• 16-item Post-Concussion Symptom Checklist (PCSC)

  including Headache, dizziness, nausea, vomiting, tinnitus, blurred vision, tiredness, poor physical strength, sleep disturbances, memory impairment, unresponsiveness, depression, irritability, difficulty concentrating, and other symptoms. The CPCS is divided into two parts: pre-injury and post-injury, before the injury is asked whether there are 16 symptoms, if there are any, the severity of the symptoms is assessed, and the Likert Scale 5-point (0-4) score is used to compare the problem symptoms with the situation before the head injury, 0 points means "not at all", 1 point means "mild", 2 points means "moderate", 3 points means "severe", 4 points indicate "very severe", the total score is 0-64 points, the higher the score, the more severe the symptoms. After the injury, the Likert Scale was used to score 5 points (1-5), 1 point means "significantly mild", 2 points means "slightly mild", 3 points indicate "unchanged", 4 points indicate

  The measurement time points were the time of receipt and the 2nd, 4th, 8th, and 12th weeks after intervention

• Beck Anxiety Inventory(BAI)

  The patient self-assessed the level of anxiety in the past week, with the highest score of 3 and the lowest score of 0 for each question, and the score of "not at all" was 0. 1 point for "slight"; 2 points for "frequently occurring"; A score of 3 is given for "severe", with a total score ranging from 0-63, with 0-7 being "normal", 8-15 being "mild anxiety", 16-25 being "moderate anxiety" and 26-63 being "severe anxiety"

  The measurement time points were the time of receipt and the 2nd, 4th, 8th, and 12th weeks after intervention

• Quality of Life after Brain Injury(QOLIBRI)

  Applicable to traumatic brain injury and at all points in time after injury, it consists of 37 items in 2 parts, 6 aspects of satisfaction, including cognition, self (including, e.g., energy, motivation, self-esteem, self-perception), daily life and autonomy, social relationships, emotions, and physical problems. The first part assesses the patient's four aspects: cognition (7 items), self (7 items), daily life and autonomy (7 items), and social relationships (6 items), while the second part assesses two aspects: emotions (5 items) and physical problems (5 items). The Likert Scale is scored on a 5-point scale (1-5), ranging from 1 (no distress at all) to 5 (very distressed), in which emotional and physical conditions are inversely scored, with higher total scores indicating higher quality of life

  The measurement time points were the time of receipt and the 4th, 8th, and 12th weeks after intervention

Study Arms (2)

Vestibular Rehabilitation therapy

EXPERIMENTAL

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

Behavioral: Vestibular Rehabilitation therapy

standard care

EXPERIMENTAL

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

Behavioral: Vestibular Rehabilitation therapy

Interventions

Vestibular Rehabilitation therapy 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

Vestibular Rehabilitation therapy; standard care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan Universiyt Hospital Yunlin Branch

Yuanlin, Taiwan

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Dizziness

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hui-Chun Liao

  National Taiwan Hospital Yunlin Branch

  PRINCIPAL INVESTIGATOR

• Pei-Yin Sun

  National Taiwan Hospital Yunlin Branch

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: May 20, 2022
• Primary Completion: June 17, 2023
• Study Completion: June 17, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-10

Locations

TW (1)