Concussion, Mild Traumatic Brain Injury, Sport-Related Concussion
Conditions
Keywords
Concussion, Persistent Symptoms, Children, Exercise, Adolescents, Active Rehabilitation, Education
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
Interventions
The active rehabilitation intervention is a 6-week graded rehabilitation program, consisting of four components that are anchored in neuroscience evidence.The four components include: 1) aerobic exercise 2) coordination exercise 3) visualization 4) home program.
OTHERComprehensive Education Intervention (Standard Care)
An initial education session will be provided by an occupational therapist related to general concussion information and outcomes, as well as strategies for symptom management following concussion.
Sponsors
Holland Bloorview Kids Rehabilitation Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Concussion Symptoms | Week 0 (Baseline) | The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion. |
| Post Concussion Symptoms | Week 2 | The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Energy Level | Week 0 (Baseline) | Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue |
| Quality of Life Level | Week 0 (Baseline) | Pediatric Quality of Life Generic Module will be used to look at quality of life |
| SCAT Balance | Week 0 (Baseline) | Sport Concussion Assessment Tool- 3rd Edition Balance Subtest will be used. This measure looks at static balance and postural stability. Youth are asked to perform three different stances on a firm surface for 20 seconds each. |
| Balance | Week 0 (Baseline) | Bruininks-Oseretsky Test of Motor Proficiency, Second Edition Balance Subtest will be used. This is used to assess static and dynamic balance with focus on the youth's anticipatory postural control. |
| Neurocognitive | Week 0 (Baseline) | ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion. |
| Mood | Week 0 (Baseline) | The Beck Depression Inventory for Youth- Second Edition will be used. This is a screen that was designed for youth and provides insight into negative thoughts and feelings towards self, life and future. |
| Activity Participation | Week 0 (Baseline) | Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation. |
| Satisfaction Level | Week 0 (Baseline) | Pediatric Quality of Life Health Care Satisfaction Generic Module will be used to gain an understanding of the participants' perceptions of the quality and effectiveness of the intervention. |
| Acute Concussion Evaluation | Week 0 (Baseline) | Acute Concussion Evaluation will be used to collect demographic information such as characteristics of the injury, signs and symptoms of the injury, and risk factors that may predict prolonged recovery. |
| Occupational Performance | Week 0 (Baseline) | The Canadian Occupational Performance Measure will be used to identify occupational performance issues as a platform for goal setting. Participants' rate their satisfaction and performance in self-identified activities that they would like to improve their satisfaction and performance in. |
| Anxiety | Week 0 (Baseline) | State Trait Anxiety Scale will be used to look at parental anxiety |
| Behavior | Week 0 (Baseline) | The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth. |
Countries
Canada
Outcome results
None listed