ConcussionConcussion HEPNCT07099248
Cervico-vestibular Home Exercise Program Feasibility
A study testing Cervico-vestibular Home Exercise Program in people with Concussion and Sports Injuries in Children, run by Texas Scottish Rite Hospital for Children at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Concussion, Sports Injuries in Children
- What is being tested?
- Cervico-vestibular Home Exercise Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2025to 18 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Acceptability of a Cervico-vestibular Home Exercise Program Following Concussion in Children
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.
Read the 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
- Being tested
- Cervico-vestibular Home Exercise Program
- Keywords
- Concussion, Home Exercise Program
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervico-vestibular Home Exercise ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Home Exercise Program | Experimental | 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. Receives: Other: Cervico-vestibular Home Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervico-vestibular HEP Acceptability of Intervention Measure (AIM)
Measured: Follow-up visit (~1-3 weeks after initial clinic visit)
1 week Protocol Adherence
This survey assessed each patients' progression in the concussion HEP, if they've complied with the recommendation of completing each day, if their symptoms were a barrier to completing the HEP, and if they had difficulties in accessing the HEP exercises on Medbridge or logging them on the paper log.
Measured: ~1 week after initial visit
Concussion Home Exercise Program Tracking Log
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.
Measured: Follow-up visit (~1-3 weeks after initial clinic visit)
Wong-Baker Faces Pain Rating Scale
Measured on a scale 0 - 10; 0 = Feeling Good, 10 = Worst I have ever felt
Measured: Up to 2 weeks after initial visit
Concussion Home Exercise Program Adherence via Medbridge GO
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.
Measured: Follow-up visit (~1-3 weeks after initial visit)
1-month post-injury outcomes and exercise continuation
This survey asks patients if they have been cleared to begin RTP after not being cleared at their follow-up clinic visit, returned to normal leaning at school, if their concussion symptoms have resolved, and if they continued to do their HEP exercises.
Measured: ~1 month after initial visit
Concussion Learning Assessment and School Survey (CLASS)
Measured: Initial visit and follow-up visit (~1-3 weeks after initial visit)
Secondary outcomes (6)
King-Devick Test
Measured: Initial visit and follow-up visit (~1-3 weeks after initial visit)
Modified Balance Error Scoring System (mBESS)
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)
Measured: Initial visit and follow-up visit (~1-3 weeks after initial visit)
Child Balance Error Scoring System (Child BESS)
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)
Measured: Initial visit and follow-up visit (~1-3 weeks after initial visit)
ImPACT Test
Measured: Initial visit and follow-up visit (~1-3 weeks after initial visit)
Post-Concussion Symptom Inventory (PCSI)
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)
Measured: Initial visit and follow-up visit (~1-3 weeks after initial visit)
Vestibular Oculomotor Motor Screening (VOMS)
Measured: Initial visit and follow-up visit (~1-3 weeks after initial visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start26 Nov 2025
- Primary completion4 May 2026
- Study completion18 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Scottish Rite Hospital for Children
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shane Miller, MD, Principal investigator, Scottish Rite for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07099248
- Sponsor's protocol ID
- STU-2025-0568
- Acronym
- Concussion HEP
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) will be shared following publication of the primary study results. Requests for data access can be submitted to Anna Wilhelmy, Bobby Van Pelt or Dr. Angela Shierk starting 6 months after publication, and data will be available for a period of 24 months. De-identified participant data and data dictionaries will be shared. Access will be granted to researchers with appropriate IRB/ethics approval.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Cervico-vestibular Home Exercise Program Following Concussion in Children
- ClinicalTrials.gov ID
- NCT07099248
- Acronym / sponsor ID
- Concussion HEP / STU-2025-0568
- Conditions
- Concussion, Sports Injuries in Children
- Keywords
- Concussion, Home Exercise Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Texas Scottish Rite Hospital for ChildrenUniversity, hospital or other
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 18 May 2026 (actual)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Exercise Program | Experimental | Other: Cervico-vestibular Home Exercise ProgramPatients 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. |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- Patients ≥18 years old
- Moderate and severe TBI
- History of seizures
- History of >3 prior concussions
- History of chronic headaches/migraines
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervico-vestibular Home Exercise ProgramPatients 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. | Other | Home Exercise Program |
Primary outcome
Cervico-vestibular HEP Acceptability of Intervention Measure (AIM)
Time frame: Follow-up visit (~1-3 weeks after initial clinic visit)
1 week Protocol Adherence
Time frame: ~1 week after initial visit
This survey assessed each patients' progression in the concussion HEP, if they've complied with the recommendation of completing each day, if their symptoms were a barrier to completing the HEP, and if they had difficulties in accessing the HEP exercises on Medbridge or logging them on the paper log.
Concussion Home Exercise Program Tracking Log
Time frame: 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.
Wong-Baker Faces Pain Rating Scale
Time frame: Up to 2 weeks after initial visit
Measured on a scale 0 - 10; 0 = Feeling Good, 10 = Worst I have ever felt
Concussion Home Exercise Program Adherence via Medbridge GO
Time frame: 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.
1-month post-injury outcomes and exercise continuation
Time frame: ~1 month after initial visit
This survey asks patients if they have been cleared to begin RTP after not being cleared at their follow-up clinic visit, returned to normal leaning at school, if their concussion symptoms have resolved, and if they continued to do their HEP exercises.
Concussion Learning Assessment and School Survey (CLASS)
Time frame: Initial visit and follow-up visit (~1-3 weeks after initial visit)
6 secondary outcomes
King-Devick Test
Time frame: Initial visit and follow-up visit (~1-3 weeks after initial visit)
Modified Balance Error Scoring System (mBESS)
Time frame: Initial visit and follow-up visit (~1-3 weeks after initial visit)
Child Balance Error Scoring System (Child BESS)
Time frame: Initial visit and follow-up visit (~1-3 weeks after initial visit)
ImPACT Test
Time frame: Initial visit and follow-up visit (~1-3 weeks after initial visit)
Post-Concussion Symptom Inventory (PCSI)
Time frame: Initial visit and follow-up visit (~1-3 weeks after initial visit)
Vestibular Oculomotor Motor Screening (VOMS)
Time frame: Initial visit and follow-up visit (~1-3 weeks after initial visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be shared following publication of the primary study results. Requests for data access can be submitted to Anna Wilhelmy, Bobby Van Pelt or Dr. Angela Shierk starting 6 months after publication, and data will be available for a period of 24 months. De-identified participant data and data dictionaries will be shared. Access will be granted to researchers with appropriate IRB/ethics approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shane Miller, MD principal investigator
Scottish Rite for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervico-vestibular Home Exercise Program in people with Concussion and Sports Injuries in Children, run by Texas Scottish Rite Hospital for Children at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervico-vestibular HEP Acceptability of Intervention Measure (AIM) (time frame: Follow-up visit (~1-3 weeks after initial clinic visit)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.