Cervico-vestibular Home Exercise Program Feasibility

Not Applicable

Not yet recruiting

• Conditions: Concussion; Sports Injuries in Children

• Registration Number: NCT07099248
• Lead Sponsor: Texas Scottish Rite Hospital for Children

Brief Summary

The purpose of this pilot study is to:

1. Determine the feasibility of adherence to completing the home cervico-vestibular exercise program following concussion.

2. Investigate the acceptability of the cervico-vestibular home exercise program.

3. Investigate the impact of the cervico-vestibular home exercise program on symptom reduction, return to play, and return to learn

4. 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.

Detailed Description

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.

At the follow-up visit, patients and their caregiver(s) will be provided with a survey by a member of the study team. This survey will consist of post-intervention questions that ask about the acceptability of the HEP, with questions such as their ability and access to time to perform the exercises, their ability to progress to higher levels/intensities, if they continued the HEP as their symptoms began to improve, and if they believe the HEP helped in their recovery from concussion. Outcomes such as CLASS, time to symptom resolution, return to play and return to learn will also be collected.

OPTIONAL: Patients will be contacted by a member of the study team via phone call, e-mail or text messaging approximately 1 month after their initial clinic visit. The purpose of contacting the patient at this time point will be to ask if the patient has returned to play or returned to learn, as well as if they continued to perform their home program exercises after their follow-up visit. Patients will be contacted approximately 1-month post-clinic visit only if they are not cleared to return to play and/or learn at their follow-up visit.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-17
• Study First Submitted QC: 2025-07-25
• Last Update Submitted: 2025-07-25
• Study First Posted: 2025-08-01
• Last Update Posted: 2025-08-01
• Study Start: 2025-09-01
• Primary Completion: 2026-07
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients <18 years old
2. Presenting to clinic ≤1 month after injury
3. Diagnosed with a concussion at their clinic visit
4. Have a total symptom score of 3 or more on the PCSI
5. Visual acuity/hearing adequate for testing
6. Parent/patient must be fluent in English
7. Ability to provide assent, Legally Appointed Representative available to provide informed consent

Exclusion Criteria

1. Patients ≥18 years old
2. Moderate and severe TBI
3. History of seizures
4. History of >3 prior concussions
5. History of chronic headaches/migraines
6. Presenting to clinic >1 month after injury

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cervico-vestibular HEP Acceptability of Intervention Measure (AIM)	Follow-up visit (~1-3 weeks after initial clinic visit)
1 week Protocol Adherence	~1 week after initial visit
Concussion Home Exercise Program Adherence via Medbridge GO	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)	Initial visit and follow-up visit (~1-3 weeks after initial visit)
Concussion Home Exercise Program Tracking Log	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	~1 month after initial visit
Wong-Baker Faces Pain Rating Scale	Up to 2 weeks after initial visit	Measured on a scale 0 - 10; 0 = Feeling Good, 10 = Worst I have ever felt

Secondary Outcome Measures

Name	Time	Method
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)	Measures patient's ability to balance. Three different stances: Double Leg Stance, Single Leg Stance, Tandem Stance. Measured 0-30 (0 = 30 total errors, 30 = 0 total errors)
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)	Measures patient's ability to balance. Two different stances: Double Leg Stance, Tandem Stance. Measured 0-20 (0 = 20 total errors, 20 = 0 total errors)
Post-Concussion Symptom Inventory (PCSI)	Initial visit and follow-up visit (~1-3 weeks after initial visit)	Used to assess post-concussion symptoms in children and adolescents. 17 item scale (patient ages 8-12) or 21 item scale (patient ages 13-18). Scored from 0-6, 0 being none and 6 being severe. Score ranges from 0-102 (patient ages 8-12) or 0-126 (patient ages 13-18)

Trial Locations

Locations (1)

Scottish Rite for Children; 🇺🇸 Frisco, Texas, United States