Subsymptom Threshold Exercise Protocol (STEP) to Recovery Following Mild Traumatic Brain Injury: A Pilot Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Neuropsychological testing
研究概览
简要总结
The study will monitor outcomes of two interventions to develop a best practice in the treatment of mild Traumatic Brain Injury (mTBI).
详细描述
The proposed pilot randomized controlled clinical trial (RCCT) will provide preliminary data to examine the effect of a novel intervention to promote brain health after mild Traumatic Brain Injury (mTBI). The study will implement a randomized controlled clinical trial of a 6 week exercise intervention (STEP) for participants with persistent mTBI symptoms, comparing STEP to standard of care practice in the controls. We will demonstrate the feasibility and acceptability of the STEP intervention. We hypothesize that STEP will lead to meaningful improvement on objective measures of self-reported mTBI symptoms, formal neuropsychological performance, and postural stability.
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
- None
入排标准
- 年龄范围
- 14 Years 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have sustained a concussion and have not experienced symptom resolution by 4 weeks, as indicated by a Post-Concussive Scale - Revised (PCS-R) score of 20 or higher at 4 weeks post-injury or beyond;
- •Participants are high school and college age (14-22 years old);
- •English speaking. -
排除标准
- •Outside of age range for the study (High school or college age)
- •Have physical injuries or comorbidities that restrict the athlete from engaging in the exercise intervention
- •Not fluent in English -
研究组 & 干预措施
STEP arm
The Baseline Evaluation Session will include formal neuropsychological evaluation, postural stability evaluation, and an education session (education about mTBI, mTBI recovery, and expected outcomes from mTBI).
Intervention includes exercise tolerance evaluations, 3 times per week exercise by physical therapist. Self report of symptoms and exertion.
干预措施: STEP (Behavioral)
Control
The Baseline Evaluation Session will include formal neuropsychological evaluation, posturalstability evaluation, and an education session (education about mTBI, mTBI recovery, and expected outcomes from mTBI).
Control protocol includes instructions for stretching, instructions for restricting physically demanding activity during first 3 weeks of study; instructions for light, self-guided daily exercise in last 3 weeks of study. Self report of symptoms and exertion.
干预措施: Control (Behavioral)
结局指标
主要结局
Neuropsychological testing
时间窗: 6 weeks
Improved cognitive performance with the treatment, reflected in standard scores on cognitive measures.
Concussion symptom resolution
时间窗: 6 weeks
Symptom self-reports; improvement reflected by points on the scale
Postural stability
时间窗: 6 weeks
Improved balance with the treatment, reflected in reductions in errors on the Balance Error Scoring System (BESS).
次要结局
未报告次要终点
研究者
Christopher M. Bailey
Neuropsychologist and Director of Concussion Program, Neurological Institute
University Hospitals Cleveland Medical Center