A Feasibility Study for a Randomized Controlled Trial on the Effectiveness of Early Physical Therapy Intervention for Patients With Dizziness After a Sports-Related Concussion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Symptom recovery as measured by the Post Concussion Symptom (PCS) Score
研究概览
简要总结
Therefore, the purpose of this pilot study is to determine the feasibility of conducting a randomized clinical trial (RCT) on physical therapist treatment for dizziness after sports-related concussion. The specific research question for this pilot RCT is: What is the feasibility of conducting a RCT on athletes who have dizziness 10 or greater days after a sports-related concussion to explore the effectiveness of directed vestibular rehabilitation, neuromotor retraining, and/or manual physical therapy (PT) when compared to sham treatment? The findings of this study (for both feasibility and effect size) will be used to inform and direct revisions to the methods for a larger RCT on this population.
Primary Aims:
Specific Aim 1: Assess the feasibility of the following: recruitment and retention of participants, required resources for project management, and assessment of patient safety.
Specific Aim 2: Estimate the size of the effect between skilled physical therapist intervention and a sham treatment for the recovery rate for athletes with a concussion who have dizziness 10 - 14 days post-concussion.
详细描述
Study design: This study will be a pilot feasibility study of a RCT, randomized at the individual level.
Subjects:
The population of interest includes athletes who are seen by the physicians from a Sports Medicine Center (on site at Akron Children's Hospital (ACH) or at proxy locations, e.g. Walsh University or North Canton Children's Hospital Clinic) with a sports-related concussion. The specific population of interest is concussed patients who present for a medical assessment with dizziness as measured by the Post-Concussion Symptom Scale (PCS).
Sample Size and Sampling: Because this is a pilot study exploring the feasibility of the recruitment, retention and methods for a larger RCT, the sample is not intended to power a full scale study. It is standard for a pilot study to include at least 12 participants per arm of the study, however, because of the potential for loss to follow up the investigators plan to enroll 20 subjects per treatment group.
Study Subject Selection and Definitions: All patients who present to a Sports Medicine Center after an acute concussion (defined as any time between the event causing the concussion and up to 14 days after concussion) will complete the PCS. Within this 22 item scale, 7 items specify physical symptoms as components of the migraine cluster. These symptoms include: headaches, visual problems, dizziness, noise-light sensitivity, nausea/vomiting, balance problems, numbness/tingling. Although dizziness is the primary patient complaint being targeted, these other symptoms within the migraine cluster may also be present in addition to dizziness and may implicate a cervical, proprioceptive, and/or vestibular injury. For this reason, patients who report symptoms in the migraine cluster with one of the following criteria will be asked to enroll in the study at the initial assessment:
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
- 10 Years 至 23 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age 10 - 23 who have sustained a sports-related concussion.
- •Sports will include participation in any organized sporting activity (including club teams, recreational sports, or school teams).
- •Patients with a history of learning disorders, use of medication (including psychotropics or narcotics) will be included.
排除标准
- •Patients younger than 10 years or older than 23 years of age.
- •If the patient has a concussion that was sustained during activities other than sports-related (bicycle accident, motor vehicle accident, or other non-sports related activities) they will not be enrolled in this study.
- •Athletes with concussion who have symptoms but none of their complaints include dizziness or indicate a postural/vestibular/ocular or perceptual abnormality will be excluded.
- •Finally, athletes who present to the sports-medicine physician for an initial assessment greater than 14 days after they sustained a concussion will be excluded.
结局指标
主要结局
Symptom recovery as measured by the Post Concussion Symptom (PCS) Score
时间窗: Final visit (by the end of 4 weeks of treatment)
7 point Likert scale (0 - 6) rating the severity of 22 symptoms commonly associated with concussion.
Return to Play (RTP)
时间窗: Final visit (by the end of 4 weeks of treatment)
Five stage progressive increase in physical activity ranging from minimal exertion to full contact in a game
次要结局
- Global Response to Treatment(Final Visit (by the end of 4 weeks of treatment))
- Change score of Vertigo Symptom Scale - Short Form(Initial assessment and final visit (by the end of 4 weeks of treatment))
- Change Score of Functional Gait Assessment(Initial assessment and final visit (by the end of 4 weeks of treatment))
研究者
Jennifer Reneker
Assistant Professor
Walsh University