Cervico-vestibular Home Exercise Program Feasibility

NCT ID: NCT07099248

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2026-08-31

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.

Conditions

Concussion; Sports Injuries in Children

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cervico-vestibular Home Exercise Program

Intervention Type: OTHER

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 cervico-vestibular home 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.

Interventions

Cervico-vestibular Home Exercise Program

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 cervico-vestibular home 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Scottish Rite Hospital for Children

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shane Miller, MD

Role: PRINCIPAL_INVESTIGATOR

Scottish Rite for Children

Locations

Scottish Rite for Children

Frisco, Texas, United States

Countries

United States

Central Contacts

Anna Wilhelmy, MS

Role: CONTACT

anna.wilhelmy@tsrh.org

(469) 857-2109

Robert Van Pelt, MPH

Role: CONTACT

bobby.vanpelt@tsrh.org

214-559-7456

Facility Contacts

Anna Wilhelmy, MS

Role: primary

anna.wilhelmy@tsrh.org

469-857-2109

Robert Van Pelt, MPH

Role: backup

bobby.vanpelt@tsrh.org

214-559-7456

Other Identifiers

STU-2025-0568

Identifier Type: -

Identifier Source: org_study_id