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Randomised controlled clinical trial of a structured cognitive rehabilitation in patients with attention deficit following mild traumatic brain injury: study protocol
Journal
BMJ Open
ISSN
2044-6055
Date Issued
2019-09
Author(s)
Norhamizan Hamzah
Vairavan Narayanan
Norlisah Ramli
Nor Atikah Mustapha
Nor Adibah Mohammad Tahir
Li Kuo Tan
Mahmoud Danaee
Nor Asiah Muhamad
Avril Drummond
Roshan das Nair
Sing Yau Goh
Mazlina Mazlan
DOI
10.1136/bmjopen-2018-028711
Abstract
Objectives
To measure the clinical, structural and functional changes of an individualised structured cognitive rehabilitation in mild traumatic brain injury (mTBI) population.
Setting
A single centre study, Malaysia.
Participants
Adults aged between 18 and 60 years with mTBI as a result of road traffic accident, with no previous history of head trauma, minimum of 9 years education and abnormal cognition at 3 months will be included. The exclusion criteria include pre-existing chronic illness or neurological/psychiatric condition, long-term medication that affects cognitive/psychological status, clinical evidence of substance intoxication at the time of injury and major polytrauma. Based on multiple estimated calculations, the minimum intended sample size is 50 participants (Cohen’s d effect size=0.35; alpha level of 0.05; 85% power to detect statistical significance; 40% attrition rate).
Interventions
Intervention group will receive individualised structured cognitive rehabilitation. Control group will receive the best patient-centred care for attention disorders. Therapy frequency for both groups will be 1 hour per week for 12 weeks.
Outcome measures
Primary: Neuropsychological Assessment Battery-Screening Module (S-NAB) scores.
Secondary: Diffusion Tensor Imaging (DTI) parameters and Goal Attainment Scaling score (GAS).
Results
Results will include descriptive statistics of population demographics, CogniPlus cognitive program and metacognitive strategies. The effect of intervention will be the effect size of S-NAB scores and mean GAS T scores. DTI parameters will be compared between groups via repeated measure analysis. Correlation analysis of outcome measures will be calculated using Pearson’s correlation coefficient.
Conclusion
This is a complex clinical intervention with multiple outcome measures to provide a comprehensive evidence-based treatment model.
Ethics and dissemination
The study protocol was approved by the Medical Research Ethics Committee UMMC (MREC ID NO: 2016928–4293). The findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.
Trial registration number
NCT03237676
To measure the clinical, structural and functional changes of an individualised structured cognitive rehabilitation in mild traumatic brain injury (mTBI) population.
Setting
A single centre study, Malaysia.
Participants
Adults aged between 18 and 60 years with mTBI as a result of road traffic accident, with no previous history of head trauma, minimum of 9 years education and abnormal cognition at 3 months will be included. The exclusion criteria include pre-existing chronic illness or neurological/psychiatric condition, long-term medication that affects cognitive/psychological status, clinical evidence of substance intoxication at the time of injury and major polytrauma. Based on multiple estimated calculations, the minimum intended sample size is 50 participants (Cohen’s d effect size=0.35; alpha level of 0.05; 85% power to detect statistical significance; 40% attrition rate).
Interventions
Intervention group will receive individualised structured cognitive rehabilitation. Control group will receive the best patient-centred care for attention disorders. Therapy frequency for both groups will be 1 hour per week for 12 weeks.
Outcome measures
Primary: Neuropsychological Assessment Battery-Screening Module (S-NAB) scores.
Secondary: Diffusion Tensor Imaging (DTI) parameters and Goal Attainment Scaling score (GAS).
Results
Results will include descriptive statistics of population demographics, CogniPlus cognitive program and metacognitive strategies. The effect of intervention will be the effect size of S-NAB scores and mean GAS T scores. DTI parameters will be compared between groups via repeated measure analysis. Correlation analysis of outcome measures will be calculated using Pearson’s correlation coefficient.
Conclusion
This is a complex clinical intervention with multiple outcome measures to provide a comprehensive evidence-based treatment model.
Ethics and dissemination
The study protocol was approved by the Medical Research Ethics Committee UMMC (MREC ID NO: 2016928–4293). The findings of the trial will be disseminated through peer-reviewed journals and scientific conferences.
Trial registration number
NCT03237676
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