Feasibility and Acceptability of a Cervico-vestibular Home Exercise Program Following Concussion in Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Cervico-vestibular HEP Acceptability of Intervention Measure (AIM)
研究概览
简要总结
The purpose of this pilot study is to:
- Determine the feasibility of adherence to completing the home cervico-vestibular exercise program following concussion.
- Investigate the acceptability of the cervico-vestibular home exercise program.
- Investigate the impact of the cervico-vestibular home exercise program on symptom reduction, return to play, and return to learn
- Analyze the timing at which a home exercise program is typically prescribed.
Participants will be asked to do and keep track of exercises made to help in their concussion recovery over a two-week period. Participants will come back to see their doctor and complete surveys about how easy the exercises were to do and if they liked them.
详细描述
This will be a prospective clinical trial of the acceptability and feasibility of HEP prescription following a concussion in the pediatric population.
Patients who consent to participate in this study will be given an informational handout by clinical athletic trainers that provides information about the study, the exercises in their exercise program, and a detailed progression to higher HEP levels/intensities based on their symptoms. The handout will also provide the purpose of the program, definitions of unfamiliar terms, a planning section for frequency and success, how to monitor symptoms through program completion, and how to properly access their exercises, log their completion, and track their progression in the Medbridge Go app.
The exercises that will make up the HEP will consist of: aerobic activity; horizontal saccades; vertical saccades; horizontal imaginary targets; vertical imaginary targets; pencil push-ups; Vestibulo-Ocular Reflex (VOR)x1 Horizontal; VORx1 Vertical; Horizontal VOR Cancellation; and Vertical VOR Cancellation.
At the initial visit, participants will also receive an exercise log in which they can mark their progression in the different HEP levels/intensities each day until their follow-up visit, their symptoms before and after completing the exercises, if the exercises worsen their symptoms, and if they were able to complete their daily exercises. Patients will also be administered the Concussion Learning Assessment and School Survey (CLASS) if they are seen in clinic during the school year.
Approximately 1-week after the patients' initial clinic visit, a member of the study team will contact the patient and their family via phone call, email or text messaging and ask questions about the patients' status in the HEP protocol, their adherence to the protocol, and if they have had any difficulties in performing and/or logging the exercises on their paper/virtual exercise log. If the patient remarks on any difficulties in performing and/or logging the exercises, a member of the study team will inform the clinical treatment staff and they will reach out to the patient and/or family to instruct them on completing the program again.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients <18 years old
- •Presenting to clinic ≤1 month after injury
- •Diagnosed with a concussion at their clinic visit
- •Have a total symptom score of 3 or more on the PCSI
- •Visual acuity/hearing adequate for testing
- •Parent/patient must be fluent in English
- •Ability to provide assent, Legally Appointed Representative available to provide informed consent
排除标准
- •Patients ≥18 years old
- •Moderate and severe TBI
- •History of seizures
- •History of >3 prior concussions
- •History of chronic headaches/migraines
- •Presenting to clinic >1 month after injury
研究组 & 干预措施
Home Exercise Program
Patients will be given an informational handout by clinical athletic trainers that provides information about the study, the exercises in their exercise program, a detailed progression to higher HEP levels/intensities based on their symptoms, and a walkthrough on how to log their progression in the Medbridge GO app. They will also receive a paper exercise log in which they can mark their progression in the different HEP levels/intensities each day until their follow-up visit, their symptoms before and after completing the exercises, if the exercises worsen their symptoms, and if they were able to complete their daily exercises.
干预措施: Cervico-vestibular Home Exercise Program (Other)
结局指标
主要结局
Cervico-vestibular HEP Acceptability of Intervention Measure (AIM)
时间窗: Follow-up visit (~1-3 weeks after initial clinic visit)
1 week Protocol Adherence
时间窗: ~1 week after initial visit
Concussion Home Exercise Program Adherence via Medbridge GO
时间窗: Follow-up visit (~1-3 weeks after initial visit)
Analysis of data from the app the athletic trainers will use to prescribe the cervico-vestibular home exercise program to patients. It will contain information regarding if they completed their exercises and at what level.
Concussion Learning Assessment and School Survey (CLASS)
时间窗: Initial visit and follow-up visit (~1-3 weeks after initial visit)
Concussion Home Exercise Program Tracking Log
时间窗: Follow-up visit (~1-3 weeks after initial clinic visit)
Paper sheet that allows patients to track the cervico-vestibular exercises they complete each day, the level at which they complete them, if completing them made their symptoms worse, and if they were able to complete the exercises.
1-month post-injury outcomes and exercise continuation
时间窗: ~1 month after initial visit
Wong-Baker Faces Pain Rating Scale
时间窗: Up to 2 weeks after initial visit
Measured on a scale 0 - 10; 0 = Feeling Good, 10 = Worst I have ever felt
次要结局
- Vestibular Oculomotor Motor Screening (VOMS)(Initial visit and follow-up visit (~1-3 weeks after initial visit))
- King-Devick Test(Initial visit and follow-up visit (~1-3 weeks after initial visit))
- Modified Balance Error Scoring System (mBESS)(Initial visit and follow-up visit (~1-3 weeks after initial visit))
- ImPACT Test(Initial visit and follow-up visit (~1-3 weeks after initial visit))
- Child Balance Error Scoring System (Child BESS)(Initial visit and follow-up visit (~1-3 weeks after initial visit))
- Post-Concussion Symptom Inventory (PCSI)(Initial visit and follow-up visit (~1-3 weeks after initial visit))