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feasibility; challenges with recruitment
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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Rehabilitation | Experimental | Active Rehabilitation Intervention and Comprehensive Education Intervention (Standard Care) |
|
| Comprehensive Education Intervention | Active Comparator | Comprehensive Education Intervention (Standard Care) only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active Rehabilitation | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Post-Concussion Symptoms | 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. | Week 0 (Baseline) |
| Post Concussion Symptoms | 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. | Week 2 |
| Post Concussion Symptoms | 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. | Week 6 (upon completion of intervention) |
| Measure | Description | Time Frame |
|---|---|---|
| Mood | 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. | Week 0 (Baseline) |
| Mood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nick Reed, PhD, MSc(OT) | Holland Bloorview Kids Rehabilitation Hospital/ Bloorview Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holland Bloorview Kids Rehabilitation Hospital | Toronto | Ontario | M4G 1R8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26231756 | Derived | 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. |
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|
| Comprehensive Education Intervention (Standard Care) | Other | 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. |
|
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.
| Week 6 (upon completion of the intervention) |
| Behavior | The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth. | Week 0 (Baseline) |
| Behavior | The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth. | Week 6 (upon completion of the intervention) |
| Energy Level | Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue | Week 0 (Baseline) |
| Energy Level | Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue | Week 6 (upon completion of the intervention) |
| Quality of Life Level | Pediatric Quality of Life Generic Module will be used to look at quality of life | Week 0 (Baseline) |
| Quality of Life Level | Pediatric Quality of Life Generic Module will be used to look at quality of life | Week 6 (upon completion of the intervention) |
| SCAT Balance | 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. | Week 0 (Baseline) |
| Balance | 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. | Week 0 (Baseline) |
| Balance | 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. | Week 6 (upon completion of the intervention) |
| Neurocognitive | ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion. | Week 0 (Baseline) |
| Neurocognitive | ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion. | Week 6 (upon completion of the intervention) |
| Anxiety | State Trait Anxiety Scale will be used to look at parental anxiety | Week 0 (Baseline) |
| Anxiety | State Trait Anxiety Scale will be used to look at parental anxiety | Week 6 (upon completion of the intervention) |
| Activity Participation | Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation. | Week 0 (Baseline) |
| Satisfaction Level | 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. | Week 0 (Baseline) |
| Acute Concussion Evaluation | 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. | Week 0 (Baseline) |
| Occupational Performance | 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. | Week 0 (Baseline) |
| Occupational Performance | Participants re-rate their satisfaction and performance in the three areas they self-identified as occupational concerns at week 0 (baseline) | Week 6 (upon completion of the intervention) |
| Balance | 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. | Week 6 (upon completion of intervention) |
| Activity Participation | Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation. | Week 6 (upon completion of the intervention) |
| Activity Participation | Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation. | Week 2 |
| Satisfaction Level | 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. | Week 6 (upon completion of the intervention) |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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