A therapeutic intervention, open label study to compare the efficacy and safety of graded exercise compared to passive stretching in adults who have sustained a mild traumatic brain injury

The Alfred0 个研究点目标入组 296 人开始时间: 2023年4月19日最近更新: 2023年4月24日

适应症

试验速览

暂无简介。

•Participants will be patients with mild traumatic brain injury (mTBI) presenting to the Emergency Department (ED) within 48 hours of injury. Eligible patients will have a diagnosis of mTBI as per treating clinical staff. mTBI will be defined according to the WHO Collaborating Task Force on mTBI criteria, which requires an acute brain injury resulting from mechanical energy to the brain from external physical forces and (i) one or more of the following: confusion or disorientation, loss of consciousness (LOC) for 30 minutes or less, post traumatic amnesia (PTA) for less than 24 hours, and/or other transient neurological abnormalities such as focal signs or seizure; (ii) a Glasgow Coma Scale (GCS) of 13-15 after 30 minutes, or upon presentation for healthcare. Ambulance records and hospital notes will be reviewed to confirm the details of memories described by participants.

•(1) Evidence of focal neurological deficit;
•(2) Inability to exercise because of orthopaedic injury, cervical spine injury, diabetes, or known heart disease;
•(3) Increased cardiac risk according to American College of Sports Medicine criteria
•(4) History of moderate or severe TBI, defined as a brain injury with an associated Glasgow Coma Scale score of 12 or less;
•(5) Current diagnosis of and treatment with medication for attention-deficit/hyperactivity disorder, learning disorder, depression, anxiety, or history of more than 3 prior concussions
•(6) sustaining another head injury during the research period before recovery;
•(7) limited English proficiency precluding completion of measures;
•(8) no symptoms exceeding pre-injury levels on the Rivermead Post-Concussion Symptoms Questionnaire, or no more than 2 mild symptoms exceeding pre-injury levels at initial clinical visit; and
•(9) an ability to exercise to exhaustion without symptom exacerbation on the first visit

发起方

The Alfred