TY  - JOUR
PY  - 2019//
TI  - Randomised controlled clinical trial of a structured cognitive rehabilitation in patients with attention deficit following mild traumatic brain injury: study protocol
JO  - BMJ open
A1  - Hamzah, Norhamizan
A1  - Narayanan, Vairavan
A1  - Ramli, Norlisah
A1  - Mustapha, Nor Atikah
A1  - Mohammad Tahir, Nor Adibah
A1  - Tan, Li Kuo
A1  - Danaee, Mahmoud
A1  - Muhamad, Nor Asiah
A1  - Drummond, Avril
A1  - das Nair, Roshan
A1  - Goh, Sing Yau
A1  - Mazlan, Mazlina
SP  - e028711
EP  - e028711
VL  - 9
IS  - 9
N2  - 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: <b>Primary:</b> Neuropsychological Assessment Battery-Screening Module (S-NAB) scores. <b>Secondary:</b> Diffusion Tensor Imaging (DTI) parameters and Goal Attainment Scaling score (GAS). <br><br>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. <br><br>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.<br><br>© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.<p />  <p>Language: en</p>
LA  - en
SN  - 2044-6055
UR  - http://dx.doi.org/10.1136/bmjopen-2018-028711
ID  - ref1
ER  -