Cervico-vestibular Home Exercise Program Feasibility
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 17
SponsorTexas Scottish Rite Hospital for Children
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients ≥18 years old
Moderate and severe TBI
History of seizures
History of >3 prior concussions
Trial design
Design model
Single group
Treatments tested in this trial
Cervico-vestibular Home Exercise Program
Other interventionPatients 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Home Exercise ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Cervico-vestibular HEP Acceptability of Intervention Measure (AIM)
Time frame
Follow-up visit (~1-3 weeks after initial clinic visit)2
1 week Protocol Adherence
Time frame
~1 week after initial visit3
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.
Time frame
Follow-up visit (~1-3 weeks after initial clinic visit)4
Wong-Baker Faces Pain Rating Scale
Measured on a scale 0 - 10; 0 = Feeling Good, 10 = Worst I have ever felt
Time frame
Up to 2 weeks after initial visitSecondary outcomes
1
King-Devick Test
Time frame
Initial visit and follow-up visit (~1-3 weeks after initial visit)2
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)
Time frame
Initial visit and follow-up visit (~1-3 weeks after initial visit)3
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)
Time frame
Initial visit and follow-up visit (~1-3 weeks after initial visit)4
ImPACT Test
Time frame
Initial visit and follow-up visit (~1-3 weeks after initial visit)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: