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Trial Study of an Exercise Program for Youth With Persistent Symptoms After Concussion

Primary Purpose

Concussion, Sport-Related Concussion, Mild Traumatic Brain Injury

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active Rehabilitation
Comprehensive Education Intervention (Standard Care)
Sponsored by
Holland Bloorview Kids Rehabilitation Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion focused on measuring Concussion, Persistent Symptoms, Children, Exercise, Adolescents, Active Rehabilitation, Education

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Holland Bloorview Kids Rehabilitation Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active Rehabilitation

Comprehensive Education Intervention

Arm Description

Active Rehabilitation Intervention and Comprehensive Education Intervention (Standard Care)

Comprehensive Education Intervention (Standard Care) only

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.
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.
Behavior
The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth.
Behavior
The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth.
Energy Level
Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue
Energy Level
Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue
Quality of Life Level
Pediatric Quality of Life Generic Module will be used to look at quality of life
Quality of Life Level
Pediatric Quality of Life Generic Module will be used to look at quality of life
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.
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.
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.
Neurocognitive
ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion.
Neurocognitive
ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion.
Anxiety
State Trait Anxiety Scale will be used to look at parental anxiety
Anxiety
State Trait Anxiety Scale will be used to look at parental anxiety
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.
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.
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.
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.
Occupational Performance
Participants re-rate their satisfaction and performance in the three areas they self-identified as occupational concerns at week 0 (baseline)
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.
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.
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.
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.

Full Information

First Posted
October 2, 2014
Last Updated
March 10, 2022
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02257749
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
feasibility; challenges with recruitment
Study Start Date
January 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holland Bloorview Kids Rehabilitation Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Sport-Related Concussion, Mild Traumatic Brain Injury
Keywords
Concussion, Persistent Symptoms, Children, Exercise, Adolescents, Active Rehabilitation, Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Rehabilitation
Arm Type
Experimental
Arm Description
Active Rehabilitation Intervention and Comprehensive Education Intervention (Standard Care)
Arm Title
Comprehensive Education Intervention
Arm Type
Active Comparator
Arm Description
Comprehensive Education Intervention (Standard Care) only
Intervention Type
Other
Intervention Name(s)
Active Rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Comprehensive Education Intervention (Standard Care)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-Concussion Symptoms
Description
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.
Time Frame
Week 0 (Baseline)
Title
Post Concussion Symptoms
Description
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.
Time Frame
Week 2
Title
Post Concussion Symptoms
Description
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.
Time Frame
Week 6 (upon completion of intervention)
Secondary Outcome Measure Information:
Title
Mood
Description
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.
Time Frame
Week 0 (Baseline)
Title
Mood
Description
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.
Time Frame
Week 6 (upon completion of the intervention)
Title
Behavior
Description
The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth.
Time Frame
Week 0 (Baseline)
Title
Behavior
Description
The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth.
Time Frame
Week 6 (upon completion of the intervention)
Title
Energy Level
Description
Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue
Time Frame
Week 0 (Baseline)
Title
Energy Level
Description
Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue
Time Frame
Week 6 (upon completion of the intervention)
Title
Quality of Life Level
Description
Pediatric Quality of Life Generic Module will be used to look at quality of life
Time Frame
Week 0 (Baseline)
Title
Quality of Life Level
Description
Pediatric Quality of Life Generic Module will be used to look at quality of life
Time Frame
Week 6 (upon completion of the intervention)
Title
SCAT Balance
Description
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.
Time Frame
Week 0 (Baseline)
Title
Balance
Description
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.
Time Frame
Week 0 (Baseline)
Title
Balance
Description
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.
Time Frame
Week 6 (upon completion of the intervention)
Title
Neurocognitive
Description
ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion.
Time Frame
Week 0 (Baseline)
Title
Neurocognitive
Description
ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion.
Time Frame
Week 6 (upon completion of the intervention)
Title
Anxiety
Description
State Trait Anxiety Scale will be used to look at parental anxiety
Time Frame
Week 0 (Baseline)
Title
Anxiety
Description
State Trait Anxiety Scale will be used to look at parental anxiety
Time Frame
Week 6 (upon completion of the intervention)
Title
Activity Participation
Description
Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.
Time Frame
Week 0 (Baseline)
Title
Satisfaction Level
Description
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.
Time Frame
Week 0 (Baseline)
Title
Acute Concussion Evaluation
Description
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.
Time Frame
Week 0 (Baseline)
Title
Occupational Performance
Description
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.
Time Frame
Week 0 (Baseline)
Title
Occupational Performance
Description
Participants re-rate their satisfaction and performance in the three areas they self-identified as occupational concerns at week 0 (baseline)
Time Frame
Week 6 (upon completion of the intervention)
Title
Balance
Description
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.
Time Frame
Week 6 (upon completion of intervention)
Title
Activity Participation
Description
Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.
Time Frame
Week 6 (upon completion of the intervention)
Title
Activity Participation
Description
Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.
Time Frame
Week 2
Title
Satisfaction Level
Description
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.
Time Frame
Week 6 (upon completion of the intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Reed, PhD, MSc(OT)
Organizational Affiliation
Holland Bloorview Kids Rehabilitation Hospital/ Bloorview Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26231756
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.
Results Reference
derived

Learn more about this trial

Trial Study of an Exercise Program for Youth With Persistent Symptoms After Concussion

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