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.
Most adolescents recover within the first month following a sport-related concussion.
However, some do not. Little is known about how to best facilitate recovery when symptoms do
not resolve spontaneously and swiftly. Although active rehabilitation has been recently
suggested as a promising means of promoting recovery, current literature does not provide
adequate evidence for safe adaptation into clinical practice.
Objective: The purpose of this project is to evaluate an active rehabilitation protocol for
adolescents who are slow to recover following sport-related concussion. Primary aims: to
confirm the tolerability and safety of the active rehabilitation protocol as compared to
treatment as usual controls. Secondary aims: 1) to document the impact of active
rehabilitation on post-concussion symptoms and return to activity; 2) to explore the
intervention effects on quality of life, mood, energy level, balance, cognitive functioning,
and return to pre-injury activities.
Study design: A parallel group open label randomized comparison trial of 30 adolescents who
are slow to recover following sport-related concussion. After initial screening and
assessment, both groups will receive treatment as usual. Participants in the experimental
group will also participate in sub-symptom threshold exercise, sport-specific coordination
practice, and positive visualisation daily.
Outcome measures: The investigators will monitor for adverse events and assess
post-concussion symptoms throughout the study as a primary marker of recovery. The
investigators will also report secondary outcomes such as quality of life, mood, energy
level, balance and cognitive functioning. Finally the investigators will record rates of
return to school (full time, part time) and rates of return to sport (regular pre-injury vs.
modified level). As a result, clinicians will be able to follow a new rehabilitation
protocol in a safe and meaningful way. Lastly, research findings will be disseminated in the
form of a publication, at conferences, and via in-services.
Hypotheses:
1a. The drop-out rate will be comparable in the groups receiving treatment-as-usual (TAU)
only versus TAU plus active rehabilitation.
1b. Adverse events occurring outside of the clinic will be comparable in the groups
receiving TAU only versus TAU plus active rehabilitation.
1c. For the group receiving active rehabilitation, symptom exacerbations in the in-clinic
exercise sessions will resolve within 30 minutes.
2. Participants receiving active rehabilitation will report greater improvement of
post-concussion symptoms (primary outcome) at follow-up.
3. Participants receiving active rehabilitation will report higher quality of life, fewer
depressive symptoms, and higher energy levels; demonstrate better balance and
neuropsychological performance at follow-up; and return to their pre-injury activities at
higher rates.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| 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 |
NCT01903525 -
DHA For The Treatment of Pediatric Concussion Related to Sports Injury
|
Phase 1 | |
| Completed |
NCT02262507 -
Concussion Device Audiological Measures
|
N/A | |
| 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 |
NCT02278029 -
Driving Performance of Teenage Patients With mTBI: a Longitudinal Assessment
|
N/A | |
| Completed |
NCT02271451 -
Q-collar and Brain Injury Biomarkers
|
N/A | |
| Completed |
NCT02268240 -
Care for Post-Concussive Symptoms
|
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 BrainPulse™ as an Aid in the Diagnosis of Concussion
|
||
| Completed |
NCT02556177 -
Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
|
N/A |