Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118541
Status:
COMPLETED
Last Update Posted:
2023-11-07
First Post:
2023-11-01
Brief Title:
Vestibular Rehabilitation Exercise in Mild Traumatic Brain Injury
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Pearsons correlation coefficient Fishers exact test and generalized estimating equations
A total of 70 mTBI patients were enrolled in this study with an average age of 5440 2043 years The majority were male 6280 and the average time from injury to vestibular rehabilitation exercise initiation was 24 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 005 except for education level p 0005 There were no significant differences in the DHI DVAS immediate standing balance test and PCSC scores between the two groups p 005 at baseline However significant differences were observed in anxiety levels p 0032 and quality of life p 0030 Results revealed the following Dizziness Both groups showed significant improvements in DHI and DVAS scores over time p 0001 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 005 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 0001 indicating gradual improvement in post-concussion symptoms However the experimental group showed a significant group and time interaction effect at week 4 p 0033 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 0001 The experimental group exhibited significant group and time interaction effects at weeks 4 8 and 12 p 001 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 0001 The experimental group exhibited significant group and time interaction effects at weeks 4 8 and 12 p 0001 indicating better improvement in quality of life compared to the control group Anxiety Both groups demonstrated significant reductions in anxiety scores over time p 0001 The experimental group exhibited significant group and time interaction effects at weeks 2 4 8 and 12 p 001 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
A total of 70 mTBI patients were enrolled in this study with an average age of 5440 2043 years The majority were male 6280 and the average time from injury to vestibular rehabilitation exercise initiation was 24 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 005 except for education level p 0005 There were no significant differences in the DHI DVAS immediate standing balance test and PCSC scores between the two groups p 005 at baseline However significant differences were observed in anxiety levels p 0032 and quality of life p 0030 Results revealed the following Dizziness Both groups showed significant improvements in DHI and DVAS scores over time p 0001 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 005 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 0001 indicating gradual improvement in post-concussion symptoms However the experimental group showed a significant group and time interaction effect at week 4 p 0033 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 0001 The experimental group exhibited significant group and time interaction effects at weeks 4 8 and 12 p 001 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 0001 The experimental group exhibited significant group and time interaction effects at weeks 4 8 and 12 p 0001 indicating better improvement in quality of life compared to the control group Anxiety Both groups demonstrated significant reductions in anxiety scores over time p 0001 The experimental group exhibited significant group and time interaction effects at weeks 2 4 8 and 12 p 001 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None