Cervico-vestibular Home Exercise Program Feasibility

NCT07099248 | Not Yet Recruiting DMC

• 1 other identifier: STU-2025-0568
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to:

1. 1.Determine the feasibility of adherence to completing the home cervico-vestibular exercise program following concussion.
2. 2.Investigate the acceptability of the cervico-vestibular home exercise program.
3. 3.Investigate the impact of the cervico-vestibular home exercise program on symptom reduction, return to play, and return to learn
4. 4.Analyze the timing at which a home exercise program is typically prescribed.

Conditions

Concussion; Sports Injuries in Children

Keywords

Concussion; Home Exercise Program

Outcome Measures

Primary Outcomes (7)

• 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 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.

  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

  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.

  Follow-up visit (~1-3 weeks after initial visit)

• 1-month post-injury outcomes and exercise continuation

  ~1 month after initial visit

• Concussion Learning Assessment and School Survey (CLASS)

  Initial visit and follow-up visit (~1-3 weeks after initial visit)

Secondary Outcomes (6)

• 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)

• Child Balance Error Scoring System (Child BESS)

  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)

• Post-Concussion Symptom Inventory (PCSI)

  Initial visit and follow-up visit (~1-3 weeks after initial visit)

Study Arms (1)

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.

Other: Cervico-vestibular Home Exercise Program

Interventions

Cervico-vestibular Home Exercise Program 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.

Home Exercise Program

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Texas Scottish Rite Hospital for Children: lead

Study Sites (1)

Scottish Rite for Children

Frisco, Texas, 75034, United States

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Shane Miller, MD

  Scottish Rite for Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna Wilhelmy, MS

CONTACT

(469) 857-2109; anna.wilhelmy@tsrh.org

Robert Van Pelt, MPH

CONTACT

214-559-7456; bobby.vanpelt@tsrh.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Time Frame: IPD will be available starting 6 months after publication, and data will be available for a period of 24 months.
• Access Criteria: Bobby Van Pelt and Anna Wilhelmy, the study coordinators, and Dr. Angela Shierk, the Co-Investigator, will be able to access and share the IPD, which will be de-identified participant data and data dictionaries. Access will be granted to these researchers, as they have the appropriate IRB/ethics approval.

Locations

US (1)