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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

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dc.contributor.authorNorhamizan Hamzah
dc.contributor.authorVairavan Narayanan
dc.contributor.authorNorlisah Ramli
dc.contributor.authorNor Atikah Mustapha
dc.contributor.authorNor Adibah Mohammad Tahir
dc.contributor.authorLi Kuo Tan
dc.contributor.authorMahmoud Danaee
dc.contributor.authorNor Asiah Muhamad
dc.contributor.authorAvril Drummond
dc.contributor.authorRoshan das Nair
dc.contributor.authorSing Yau Goh
dc.contributor.authorMazlina Mazlan
dc.date.accessioned2024-07-31T07:37:30Z
dc.date.available2024-07-31T07:37:30Z
dc.date.issued2019
dc.description.abstractObjectives: 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.
dc.identifier.doidoi:10.1136/bmjopen-2018-028711
dc.identifier.urihttps://repository.nih.gov.my/handle/123456789/779
dc.language.isoen
dc.relation.ispartofBMJ Open
dc.titleRandomised controlled clinical trial of a structured cognitive rehabilitation in patients with attention deficit following mild traumatic brain injury: study protocol
dc.typejournal-article
dspace.entity.typePublication
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