Concussion Clinical Trial
Official title:
Active Rehabilitation for Slow to Recover Adolescents Following Sport-Related Concussion: A Randomized Control Trial
To test the safety and feasibility of a new treatment for adolescents who are slow to recover from a sport-related concussion, the investigators are conducting a randomised controlled trial comparing treatment as usual with an active rehabilitation program that involves sub-symptom threshold cardiac exertion, sport-specific coordination activities, and positive visualisation techniques.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | February 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years to 18 Years |
Eligibility |
Adolescents referred to G. F. Strong Rehabilitation Centre (GFS) for atypical recovery
preventing them from entering standard return to activities protocols will be recruited on
a voluntary basis to participate in this study. Eligibility criteria for study entry are as follows: 1. sustained an injury in sports, 2. are 4 weeks post injury, 3. report 2+ persistent post-concussion symptoms with no significant improvement over the past week, 4. are between the ages of 14 and 18, 5. have no developmental, congenital, or cognitive diagnoses, 6. have no active mental health disorders, 7. are able to attend at GFS, 8. speak English as their dominant language, 9. have no prior moderate or severe TBI, 10. have no concussion in the 6 months before the present injury, and 11. medical clearance by the study physician. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | GF Strong Rehabilitation Centre | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
University of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptom Report | The Post-Concussion Scale consists of 22 subjectively-experienced symptoms (e.g., headache, dizziness, concentration problems, and fogginess). A total score is derived from this 22-item scale. Athletes report symptoms based on the severity of each symptom that day, allowing tracking of symptoms over very short intervals | Baseline | No |
Primary | Symptom Report | At 8 weeks (end-of-treatment) | No | |
Secondary | Mood | The Beck Depression Inventory for Youth-Second Edition is a 20-item depression screening test designed for children and adolescents. | Baseline | No |
Secondary | Energy level | Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale will be used to monitor fatigue in the study participants, another commonly reported complaint after a MTBI. The PedsQL was designed to measure fatigue in pediatric patients; it includes a General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items), and Cognitive Fatigue Scale (6 items). | Baseline | No |
Secondary | Balance Testing | The Balance Error Scoring System (BESS) is a commonly used measure of static balance and postural stability. The test is rapid, relatively easy-to-administer, and inexpensive. A combination of three stances (narrow double leg stance; single leg stance; and tandem stance) and footing surfaces (firm surface/floor or medium density foam) are used for the test. Each stance is held, with hands on hips and eyes closed, for 20 seconds. "Error" points are given for specific behaviors, including opening eyes, lifting hands off hips, or stepping, stumbling, or falling. Safety Issue: Falls and fall-related injuries. Testing will be supervised by a registered physiotherapist. |
Baseline | Yes |
Secondary | Neurocognitive Testing | ImPACT is a computerized neuropsychological test battery that consists of six individual test modules that measure multiple aspects of cognitive functioning including attention, memory, working memory, visual scanning, reaction time, and processing speed. The test takes 20-25 minutes. Four composite (i.e., summary) scores are tabulated based upon these individual test scores: Verbal Memory, Visual Memory, Reaction Time, and Processing Speed. | Baseline | No |
Secondary | Return to School and Sport | Number of days away from school and sports will be documented. School status will also be rated as part-time, full-time, and with/without accommodations at different time intervals. | Baseline | No |
Secondary | Mood | The Beck Depression Inventory for Youth-Second Edition will be used | At 8 weeks (end-of-treatment) | No |
Secondary | Energy level | Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale will be used | At 8 weeks (end-of-treatment) | No |
Secondary | Balance Testing | The Balance Error Scoring System (BESS) will be used | At 8 weeks (end-of-treatment) | Yes |
Secondary | Neurocognitive Testing | ImPACT will be used. | At 8 weeks (end-of-treatment) | No |
Secondary | Return to School and Sport | Number of days away from school and sports will be documented. School status will also be rated as part-time, full-time, and with/without accommodations at different time intervals. | At 8 weeks (end-of-treatment) | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03304327 -
Mindfulness and Yoga Training for Athletes With Concussion (MYTAC)
|
N/A | |
Completed |
NCT05562544 -
EEG Diagnostic for Repetitive Sub-concussive Head Impacts
|
||
Terminated |
NCT02988609 -
Concussion in Rugby Players: a Pilot Study of Neural Recovery Using fMRI
|
N/A | |
Completed |
NCT02710123 -
Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion
|
N/A | |
Terminated |
NCT02100150 -
A Safety and Efficacy Study of NNZ-2566 in Patients With Mild Traumatic Brain Injury (mTBI)
|
Phase 2 | |
Active, not recruiting |
NCT01874847 -
PLAY GAME: Post-concussion Syndrome in Youth - Assessing the GABAergic Effects of Melatonin
|
Phase 2/Phase 3 | |
Completed |
NCT02262507 -
Concussion Device Audiological Measures
|
N/A | |
Completed |
NCT01903525 -
DHA For The Treatment of Pediatric Concussion Related to Sports Injury
|
Phase 1 | |
Enrolling by invitation |
NCT05948501 -
The Effects of Concussion on Gait and Posture in Individuals With Peripheral Vision Loss
|
||
Withdrawn |
NCT02643836 -
Pulsed Electromagnetic Field (PEMF) Therapy for Post-Concussive Syndrome
|
N/A | |
Recruiting |
NCT03360786 -
Primary Prevention of Concussion in Youth Ice Hockey Players
|
N/A | |
Recruiting |
NCT03710109 -
Evaluation of an EEG Based Concussion System
|
||
Not yet recruiting |
NCT02930395 -
Blood Biomarkers for the Management of Concussion in Professional Rugby Players
|
N/A | |
Completed |
NCT02268240 -
Care for Post-Concussive Symptoms
|
N/A | |
Completed |
NCT02278029 -
Driving Performance of Teenage Patients With mTBI: a Longitudinal Assessment
|
N/A | |
Completed |
NCT02271451 -
Q-collar and Brain Injury Biomarkers
|
N/A | |
Completed |
NCT02268058 -
Use of Ibuprofen and Acetaminophen for Treatment of Acute Headache Post Concussion in Children
|
N/A | |
Active, not recruiting |
NCT03608722 -
Video Games to Track Cognitive Health
|
N/A | |
Completed |
NCT02660164 -
A Study to Assess the Effectiveness of the Nautilus BrainPulseâ„¢ as an Aid in the Diagnosis of Concussion
|
||
Completed |
NCT02556177 -
Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
|
N/A |