Participation and Executive Functions in Adults Following Traumatic Brain Injury During Suba-Acute Inpatient Rehabilitation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The Multiple Errands Test - the hospital version (MET-HV)
研究概览
简要总结
Aim: To examine the feasibility of a new treatment protocol in improving executive function deficits and participation in daily activities of adults with TBI at discharge and one month post-discharge.
A double-blind (assessors) randomized control trial (RCT) with two groups, experimental and control.
This study will include 40 adults hospitalized in the inpatient Head Trauma unit.
Potential patients will be approached by occupational therapists working in the inpatient Head Trauma rehabilitation unit and be invited to participate in the study. If they agree, they will be asked to sign an informed consent form. Then they will undergo a screening assessment. Participants who are found eligible will be then administered a cognitive assessment battery. Then they will be randomly allocated to either the experimental (new treatment protocol) or the control (conventional therapy) group. In both groups, the intervention will include 18 treatment sessions of 45 minutes, between three to five times a week depending on the participant's state, over a period of four to six weeks. Following the intervention, participants will undergo the assessment again. Participation questionnaires will be administered by telephone one month post-discharge.
详细描述
A double-blind randomized control trial (RCT) with two groups, experimental and control.
This study will include 40 adults hospitalized in the inpatient Head Trauma unit.
Potential patients will be approached by occupational therapists working in the inpatient Head Trauma rehabilitation unit and be invited to participate in the study. If they agree, they will be asked to sign an informed consent form. Then they will undergo a screening assessment. Participants who are found eligible will be then administered a cognitive assessment battery. Then they will be randomly allocated to either the experimental (new treatment protocol) or the control (conventional therapy) group. In both groups, the intervention will include 18 treatment sessions of 45 minutes, between three to five times a week depending on the participant's state, over a period of four to six weeks. Following the intervention, participants will undergo the assessment again. Participation questionnaires will be administered by telephone one-month post-discharge.
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
- Single (Outcomes Assessor)
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 to severe TBI as diagnosed by a physician and confirmed by imaging
- •age 18-60
- •able to understand instructions of assessment tools as will be determined by their Occupational Therapist
- •basic cognitive abilities preserved as will be determined by three subtests of the Loewenstein Occupational Therapy Cognitive Assessment: orientation (score: 6/8 or above), visual perception (score: 3/4 or above) and spatial perception (score: 2/4 or above)
- •at least one functional upper extremity as will be determined by their Occupational Therapist
- •intact or corrected vision.
- •a score of 1 or above in the The Multiple Errands Test - the hospital version (MET-HV).
排除标准
- •history of drug use
- •other psychiatric or neurologic disorder.
结局指标
主要结局
The Multiple Errands Test - the hospital version (MET-HV)
时间窗: 30 minutes
A performance-based assessment which was design to assess the effect of EF deficits on everyday functioning.
次要结局
- Cognitive Self Efficacy Questionnaire II (CSEQ)(15 minutes)
- Self-Perceptions in Rehabilitation Questionnaire (SPIRQ)(15 minutes)
- Mayo-Portland Adaptability Inventory - 4 (MPAI-4)(15 minutes)
- Quality of Life After Brain Injury (QOLIBRI)(15 minute)
- WebNeuro neurocognitive assessment battery(30 minutes)
研究者
Rotem Eliav
Occupational therapist
Loewenstein Hospital