The Effect of Cognitive Rehabilitation Therapy in Improving Cognitive Function of Attention Following Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Change in Neuropsychological Assessment Battery- Screening score
研究概览
简要总结
This research is a randomised controlled study. The study hypothesis is cognitive rehabilitation for attention deficits following mild traumatic brain injury will improve patient's cognitive outcome, measured by neuropsychological and neuroimaging parameters. Participant recruitment is from University Malaya Medical Centre, Malaysia. All mild traumatic brain injury participants have to fulfil the study inclusion criteria and written consented for therapy. Control group receives existing patient-centred cognitive treatment whereas intervention group receives individualised structured cognitive rehabilitation therapy. The intervention begins at three months post injury and ends at six months post injury. Study outcome measurements are applied at pre and post treatment. This study was ethically approved by Medical Research Ethics Committee University Malaya Medical Centre (MREC ID NO: 2016928-4293).
详细描述
General study objective: to measure the effect of cognitive rehabilitation program for attention deficit applied in mild traumatic brain injury patients.
Specific objectives:
- To measure the effect of a 12-week cognitive rehabilitation therapy for attention deficits in mild traumatic brain injury patients using neuropsychological and functional assessments.
- To examine the correlation between neurocognitive deficits and structural brain changes at baseline and at six months post injury.
Study type and location: An interventional study conducted in University Malaya Medical Centre (UMMC), Malaysia.
Participants: Patients diagnosed with mild traumatic brain injury at Accident & Emergency Department in UMMC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants are randomised on treatment arm. Co-investigators are blinded from knowing which participant receives which treatment arm.
Cognitive outcome assessor is blinded from knowing which participant receives which treatment arm.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mild traumatic brain injury as a result of motor vehicle accidents only.
- •No previous history of head trauma.
- •Education level of a minimum of 9 years (required for neuropsychological test).
- •Normal Computed Tomography (CT) brain scan finding.
- •Able to comply with cognitive rehabilitation therapy.
- •No pre-existing chronic illness that can cause neurological complications, neurological diseases or psychiatric condition.
- •Not on any regular medication that may alter or effect cognitive and psychological status.
排除标准
- •Normal neuropsychological assessment test result at 3 months post injury (planned test time) for both study groups.
- •Clinical evidence of alcohol influence at time of injury.
- •Non Malaysian citizens
- •Major polytrauma including long bone fractures, intra-abdominal injuries and chest injuries that require surgical and/or metal insertion.
研究组 & 干预措施
Individualised structured cognitive rehabilitation therapy
Participants of interventional arm will receive individualised structured cognitive rehabilitation therapy at the proposed health centre (University Malaya Medical Centre, Malaysia).
干预措施: Structured cognitive rehabilitation therapy (Other)
Patient-centred cognitive therapy
Participants of conventional arm will receive an existing cognitive rehabilitation treatment available at the proposed health centre (University Malaya Medical Centre, Malaysia).
干预措施: Patient-centred cognitive therapy (Other)
结局指标
主要结局
Change in Neuropsychological Assessment Battery- Screening score
时间窗: Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury
Measure the change in score of Attention domain screening score and Total Screening Index Score at two different time points - 3 months and 6 months post brain injury.
次要结局
- Change in Diffusion Tensor Imaging parameters(Perform at 3 months (pre-intervention) and 6 months (completed intervention) following mild traumatic brain injury)
- Change in Goal Attainment Scaling score(Perform at 3 months (baseline) and 6 months (complete intervention) following mild traumatic brain injury)