Vestibular RehabilitationNCT06118541
Vestibular Rehabilitation Exercise in Mild Traumatic Brain Injury
A study testing Vestibular Rehabilitation therapy in people with Vestibular Rehabilitation, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Vestibular Rehabilitation
- What is being tested?
- Vestibular Rehabilitation therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 May 2022to 17 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Being tested
- Vestibular Rehabilitation therapy
- Keywords
- Traumatic Brain Injury, Vestibular Rehabilitation therapy, Dizziness, Quality of Life
- Medical subject headings
- Brain Injuries, Traumatic, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vestibular Rehabilitation therapyBehavioural
Vestibular rehabilitation exercises of 30 to 60 minutes twice a week for eight weeks
Vestibular rehabilitation exercise program:
- Eye-Head Coordination exercise
- Sitting balance exercises
- Standing Static balance exercises
- Standing Dynamic balance exercises
- Ambulation exercises
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Vestibular Rehabilitation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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"
Measured: 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
Measured: The measurement time points were the time of receipt and the 4th, 8th, and 12th weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start20 May 2022
- Primary completion17 Jun 2023
- Study completion17 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vestibular RehabilitationStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Chun Liao, Principal investigator, National Taiwan Hospital Yunlin BranchPei-Yin Sun, Principal investigator, National Taiwan Hospital Yunlin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118541
- Sponsor's protocol ID
- 202203063RINB
- Status last verified
- Oct 2023
- First submitted
- 1 Nov 2023
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06118541
- Acronym / sponsor ID
- 202203063RINB
- Conditions
- Vestibular Rehabilitation
- Keywords
- Traumatic Brain Injury, Vestibular Rehabilitation therapy, Dizziness, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 17 Jun 2023 (actual)
- Study completion
- 17 Jun 2023 (actual)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vestibular Rehabilitation therapy | Experimental | Behavioral: Vestibular Rehabilitation therapyThe 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 |
| standard care | Experimental | Behavioral: Vestibular Rehabilitation therapyMonitor 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vestibular Rehabilitation therapyVestibular 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 | Behavioural | Vestibular Rehabilitation therapy, standard care |
Primary outcome
Dizziness Handicap Inventory (DHI)
Time frame: The measurement time points were the time of receipt and the 2nd, 4th, 8th, and 12th weeks after intervention
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
Dizziness Visual Analog Scale (DVAS)
Time frame: The measurement time points were the time of receipt and the 2nd, 4th, 8th, and 12th weeks after intervention
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 5 times sit to stand test(FTSTS)
Time frame: The measurement time points were the time of receipt and the 4th, 8th, and 12th weeks after intervention
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
16-item Post-Concussion Symptom Checklist (PCSC)
Time frame: The measurement time points were the time of receipt and the 2nd, 4th, 8th, and 12th weeks after intervention
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
Beck Anxiety Inventory(BAI)
Time frame: The measurement time points were the time of receipt and the 2nd, 4th, 8th, and 12th weeks after intervention
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"
Quality of Life after Brain Injury(QOLIBRI)
Time frame: The measurement time points were the time of receipt and the 4th, 8th, and 12th weeks after intervention
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui-Chun Liao principal investigator
National Taiwan Hospital Yunlin Branch
Pei-Yin Sun principal investigator
National Taiwan Hospital Yunlin Branch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vestibular Rehabilitation therapy in people with Vestibular Rehabilitation, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dizziness Handicap Inventory (DHI) (time frame: The measurement time points were the time of receipt and the 2nd, 4th, 8th, and 12th weeks after intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.