Early Team Based Neuro-rehabilitation After Traumatic Brain Injury - a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Numbers of patients who meet the inclusion criteria and accept participation in the study?
研究概览
简要总结
The aim is to evaluate the study design, procedure and measurements in a randomised controlled pilot study.
详细描述
Despite that mild traumatic brain injury (mTBI) is a common condition managed in various healthcare settings, early team based neurorehabilitation (TbNR) in post-concussion syndrom (PCS) is sparely investigated. Therefore we aim to design a high quality randomised controlled study (RCT) investigating the effect of early TbNR in PCS. Prior this RCT a pilot study will be conducted with the aim to evaluate the study design, procedure and measurements.
Method:
Thirty consecutive patients visiting Alingsås hospital emergency department due to head injury caused by fall, trauma to the head, traffic accident or abuse, and diagnosed with brain concussion (ICD10 S060, S0600) for the first time or after repeated trauma, will be asked to participate in the study. The patient will receive a written study information when discharged, and asked if an occupational therapist can contact the patient by phone for further information and screening questions 14 days after trauma. If the patient meet the inclusion criteria and wish to participate in the study a written informed consent will be obtained.
Test procedure:
A structured interview and the assessment described below will be performed at baseline 3-4 weeks after the trauma and after 16 weeks by an occupational therapist. Participant's characteristics such as age, gender, work ability, education, social status, previous trauma to the head and known comorbidity are collected. The classification of the mTBI will be collected from the patients' medical journal, as well as the result and time of the CT examination if it has been performed. Information about previous sick leave will be collected from the Swedish health insurance office. The number of visits to the occupational therapist (OT) and the physiotherapist (PT) will be recorded from the participant's medical journal.
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)
盲法说明
After screening for eligibility, fulfilling inclusion criteria and consenting to participation the baseline assessment will be conducted by an OT at enrolment. After this the patients will be randomised either to the intervention or control group in using lots in sealed envelopes based on a computer generated group allocation. The lots are kept in sealed envelopes prepared by a person not involved in the study. An OT will open the envelope and inform the patient about group allocation. All care providers will be blinded for baseline and post-test outcomes. A research co-worker who are involved in data management will be blinded for group allocation.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Head injury for the first time or repeated trauma.
- •Diagnosed with brain concussion (ICD10 S060, S0600) by a physician.
- •Persistent symptoms after mTBI or decreased activity level at time for inclusion.
- •Exclusions criteria:
- •No remaining symptoms after mTBI at time for inclusion.
- •Returned to previous activity daily living level as before trauma.
- •Other serious illness.
- •Unwillingness to participate in the study.
排除标准
- 未提供
研究组 & 干预措施
Intervention group
Early team based neuro-rehabilitation after Traumatic Brain Injury
干预措施: Early team based neuro-rehabilitation (Behavioral)
Control group
Treatment as usual.
结局指标
主要结局
Numbers of patients who meet the inclusion criteria and accept participation in the study?
时间窗: 16 weeks after trauma
Count how many of the patients want to participate in the study
次要结局
- Numbers of participants who respond to the included measurements?(16 weeks after trauma)
- Number of head trauma(Relation between number of head trauma and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.)
- Multidimensional Fatigue Inventory (MFI)(Effect size of change from baseline to 16 weeks after trauma)
- Activity level is measured with GAP in everyday activity.(Effect size of change from baseline to 16 weeks after trauma)
- Numbers of participants who complete post-test?(16 weeks after trauma)
- Sleep quantity is measured by two questions:(Effect size of change from baseline to 16 weeks after trauma)
- Hospital Anxiety and Depression Scale (HADS Swedish version)(Effect size of change from baseline to 16 weeks after trauma)
- Trauma caused by another person or not (yes/no)(Relation between trauma caused by another person or not and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.)
- Self-reported comorbidity(Relation between self-reported comorbidity and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.)
- Rivermead post-concussion symtoms questionnaire (Swedish version) (RPQ)(Effect size of change from baseline to 16 weeks after trauma)
- Leisure Time Physical Activity Instrument (LTPI) (Swedish version)(Effect size of change from baseline to 16 weeks after trauma)
- RAND-36(Effect size of change from baseline to 16 weeks after trauma)
- Gender, male and female(Relation between gender and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.)
- Computer Tomografi (CT) assessment(Relation between CT assessment and change from baseline to 16 weeks after trauma in the outcomes measurements RPQ, MFI, LTPAI,GAP, Sleep, HADS.)