RCT of Vestibular Treatment in Adolescents Following Sport Related Concussion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in VOMS Scores (Vestibular Ocular Motor Screening) from Baseline to 4 Week/Visit 2
研究概览
简要总结
Each year, nearly 2 million children and adolescents have a sport-related concussion (SRC) in the U.S., but 57% of them do not receive appropriate clinical care following their injury. These injuries involve a wide range of symptoms including headache, dizziness, and sleep problems; and cognitive, emotional, visual, and vestibular impairment. The investigators have developed a clinical treatment model for SRC that addresses the heterogeneity of this injury using different clinical subtypes or profiles that inform precision interventions. To date, the investigators have identified cognitive, anxiety/mood, post-traumatic migraine, cervical, oculomotor, and vestibular clinical profiles. Patients with vestibular clinical profiles- involving dizziness, environmental sensitivity, and imbalance- are common (60-65% of concussions), and have worse outcomes and longer recovery following SRC. Consequently, the investigators have developed and applied precision vestibular treatments that can be matched to specific impairments and symptoms to actively treat patients with vestibular clinic profiles.
详细描述
To determine using a RCT design the effectiveness of standard of care behavioral management (i.e., sleep, walking, nutrition, stress management) to standard of care behavioral management (i.e., sleep, walking, nutrition, stress management) (STANDARD OF CARE) plus vestibular exercises (i.e., balance, eye-head movements, and dynamic walking exercises) (VESTIBULAR) for reducing recovery time, symptoms, and vestibular (balance, eye-head movements) and cognitive (e.g., memory, processing speed) impairment in adolescent patients with vestibular clinical profiles following sport--related concussion (SRC).
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, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be 12-18 years of age.
- •Must be diagnosed with a sport-related concussion within the last 3-10 days.
- •Must be identified by UPMC Sports Medicine clinicians as having clinical presentation of a vestibular profile of concussion.
- •Must report an increase of +2 of symptom provocation on VOMS (from baseline symptom report) on either VOR or VMS measurements during VOMS assessment.
排除标准
- •More than 3 concussions including presenting injury;
- •Current history or pre-existing vestibular disorder;
- •Current orthopaedic injury;
- •History of brain surgery or TBI (based on Glasgow Coma Scale of <13);
- •History of substance abuse;
- •History of neurological disorder (seizure disorder, epilepsy, brain tumors or malformations);
- •Current concussion is non-sport related.
- •The above exclusion factors are known to influence recovery and thus if any one exclusion criterion is met, the athlete will be unable to participate in the current study.
研究组 & 干预措施
Standard of Care Group
Standard of Care:
The standard of care protocol consists of standardized in office and at home behavioral management to include sleep, hydration, nutrition, and stress management interventions. Participants will also be assigned physical activity that they will complete during their visits and at home. Physical activity for the standard of care group will include 15 minutes of flexibility/range of motion exercises, and 10 minutes of aerobic-based daily physical activity (e.g.,walking, stationary cycle).
干预措施: Standard of Care (Behavioral)
Vestibular Exercise Intervention Group
The vestibular group will complete the behavioral management activities described above, as well as prescribed in-office and at home vestibular exercises from each of four groups: 1) gaze stability training (i.e., integrated eye and head movements on fixed target), 2) visual motion training (i.e., integrated eye and head movements with busy visual background), 3) standing balance (i.e., standing in different stances), and 4) dynamic gait (i.e., walking with head turns). Participants will be prescribed to one of four levels of these four exercise groups based on presentation of symptoms/impairment as indicated on the VOMS. Progression through the four levels will be based on symptom tolerance and successful completion of all exercises at the current level.
干预措施: Vestibular Exercise Intervention (Behavioral)
结局指标
主要结局
Change in VOMS Scores (Vestibular Ocular Motor Screening) from Baseline to 4 Week/Visit 2
时间窗: Measures will be conducted at enrollment (within 10 days of injury) and at 2 weeks (+ or - 5 days) and 4 weeks (+ or - 5 days) following treatment.
The VOMS assesses vestibular and ocular motor impairment via patient-reported symptom provocation brief assessments in 7 components: 1) smooth pursuits; 2, 3) horizontal and vertical saccades; 4) near point convergence (NPC); 5, 6) horizontal and vertical vestibular ocular reflex (VOR), and 7) visual motion sensitivity (VMS). Patients rate changes in headache, dizziness, nausea, and fogginess symptoms compared to immediate pre-assessment state on a scale of 0 (no symptoms) to 10 (severe symptoms) following each VOMS assessment to determine if each assessment provokes symptoms. Convergence is assessed by both symptom report and objective measurement of NPC distance, values are averaged across 3 trials. The VOMS takes approximately 5 min to administer.
次要结局
未报告次要终点
研究者
Anthony P. Kontos, Ph.D.
Associate Professor, Dept of Orthopaedic Medicine
University of Pittsburgh