Clinical trial NCT02257749: Trial Study of an Exercise Program for Youth With Persistent Symptoms After Concussion
Official title: Comparing Active Rehabilitation to a Comprehensive Education Intervention for Youth With Persistent Post-concussion Symptoms Following Concussion.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Concussion
Sport-Related Concussion
Mild Traumatic Brain Injury
Keywords: Concussion
Persistent Symptoms
Children
Exercise
Adolescents
Active Rehabilitation
Education
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
First posted: 2014-10-06
Enrollment: 1
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized control trial study is to determine if an active rehabilitation (low intensity exercise program) in combination with a comprehensive education intervention (standard care) is more effective than the comprehensive education intervention alone in reducing post-concussion symptoms and improving participation in daily activities in youth who have persistent post-concussion symptoms.

Detailed description: There is a portion of youth who continue to experience persistent post-concussion symptoms beyond the first few weeks of injury. There is limited evidence with respect to the best ways to treat persistent post-concussion symptoms in youth following concussion. There is a small amount of literature that suggests active rehabilitation as a positive intervention for promotion of recovery of persistent post-concussion symptoms. However, this approach to rehabilitation has yet to be explored using a randomized control trial protocol.

Therefore, this study aims to answer the following question: Is a 6 week active rehabilitation program in combination with a comprehensive education intervention (standard care) effective in reducing post-concussive symptoms and improving functional recovery compared to receiving comprehensive education intervention alone among youth experiencing persistent post-concussion symptoms?

We hypothesize:

1. youth ages 10 to 18 years who present with persistent self-reported post-concussion symptoms 4 weeks after the initial injury and receive the active rehabilitation intervention, will present with decreased post-concussion symptoms at the completion of the intervention.
2. youth ages 10 to 18 years who receive the active rehabilitation intervention, will present with more complete functional recovery and increased participation in unrestricted physical activity at the completion of the active rehabilitation intervention compared to children receiving the comprehensive education intervention only

Eligibility criteria: Inclusion Criteria:

* confirmed diagnosis of concussion
* have at least one post-concussion symptom (as measured by the Post Concussion Symptom Inventory)
* are at least 4 weeks post injury
* between the ages of 10 and 18 years
* ability to speak English
* ability to demonstrate capacity to consent to study

Exclusion Criteria:

* prior moderate or severe brain injury
* neck pain/dysfunction or oculormotor/vestibular dysfunction, developmental delays, mental health disorders or chronic pain conditions that prevent participation in active rehabilitation, assessment of gait and balance, or participation in cognitive testing
* participating in any other physical rehabilitation interventions for post-concussion symptoms (e.g., physiotherapy, massage therapy, chiropractic) at time of enrollment and throughout the duration of the study

Primary outcomes:
measure: Post-Concussion Symptoms
timeFrame: Week 0 (Baseline)
measure: Post Concussion Symptoms
timeFrame: Week 2
measure: Post Concussion Symptoms
timeFrame: Week 6 (upon completion of intervention)
Secondary outcomes:
measure: Mood
timeFrame: Week 0 (Baseline)
measure: Mood
timeFrame: Week 6 (upon completion of the intervention)
measure: Behavior
timeFrame: Week 0 (Baseline)
measure: Behavior
timeFrame: Week 6 (upon completion of the intervention)
measure: Energy Level
timeFrame: Week 0 (Baseline)
measure: Energy Level
timeFrame: Week 6 (upon completion of the intervention)
measure: Quality of Life Level
timeFrame: Week 0 (Baseline)
measure: Quality of Life Level
timeFrame: Week 6 (upon completion of the intervention)
measure: SCAT Balance
timeFrame: Week 0 (Baseline)
measure: Balance
timeFrame: Week 0 (Baseline)
measure: Balance
timeFrame: Week 6 (upon completion of the intervention)
measure: Neurocognitive
timeFrame: Week 0 (Baseline)
measure: Neurocognitive
timeFrame: Week 6 (upon completion of the intervention)
measure: Anxiety
timeFrame: Week 0 (Baseline)
measure: Anxiety
timeFrame: Week 6 (upon completion of the intervention)
measure: Activity Participation
timeFrame: Week 0 (Baseline)
measure: Satisfaction Level
timeFrame: Week 0 (Baseline)
measure: Acute Concussion Evaluation
timeFrame: Week 0 (Baseline)
measure: Occupational Performance
timeFrame: Week 0 (Baseline)
measure: Occupational Performance
timeFrame: Week 6 (upon completion of the intervention)
measure: Balance
timeFrame: Week 6 (upon completion of intervention)
measure: Activity Participation
timeFrame: Week 6 (upon completion of the intervention)
measure: Activity Participation
timeFrame: Week 2
measure: Satisfaction Level
timeFrame: Week 6 (upon completion of the intervention)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Holland Bloorview Kids Rehabilitation Hospital/ Bloorview Research Institute
name: Nick Reed, PhD, MSc(OT)
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reed N, Greenspoon D, Iverson GL, DeMatteo C, Fait P, Gauvin-Lepage J, Hunt A, Gagnon IJ. Management of persistent postconcussion symptoms in youth: a randomised control trial protocol. BMJ Open. 2015 Jul 31;5(7):e008468. doi: 10.1136/bmjopen-2015-008468.