ConcussionNCT02257749
Trial Study of an Exercise Program for Youth With Persistent Symptoms After Concussion
A study testing Active Rehabilitation in people with Concussion and Sport-Related Concussion, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Concussion, Sport-Related Concussion, Mild Traumatic Brain Injury
- What is being tested?
- Active Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8
About this study
Official title: Comparing Active Rehabilitation to a Comprehensive Education Intervention for Youth With Persistent Post-concussion Symptoms Following Concussion.
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.
Read the 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
- Being tested
- Active Rehabilitation, Comprehensive Education Intervention (Standard Care)
- Keywords
- Concussion, Persistent Symptoms, Children, Exercise, Adolescents, Active Rehabilitation, Education
- Medical subject headings
- Brain Concussion, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active RehabilitationOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Rehabilitation | Experimental | Active Rehabilitation Intervention and Comprehensive Education Intervention (Standard Care) Receives: Other: Active Rehabilitation; Other: Comprehensive Education Intervention (Standard Care) |
| Comprehensive Education Intervention | Active comparator | Comprehensive Education Intervention (Standard Care) only Receives: Other: Comprehensive Education Intervention (Standard Care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Week 6 (upon completion of intervention)
Secondary outcomes (24)
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.
Measured: Week 0 (Baseline)
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.
Measured: 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.
Measured: Week 0 (Baseline)
Behavior
The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth.
Measured: Week 6 (upon completion of the intervention)
Energy Level
Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue
Measured: Week 0 (Baseline)
Energy Level
Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue
Measured: 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
Measured: Week 0 (Baseline)
Quality of Life Level
Pediatric Quality of Life Generic Module will be used to look at quality of life
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6 (upon completion of the intervention)
Anxiety
State Trait Anxiety Scale will be used to look at parental anxiety
Measured: Week 0 (Baseline)
Anxiety
State Trait Anxiety Scale will be used to look at parental anxiety
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 6 (upon completion of the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2014 (estimated)
- Study startJan 2016
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: feasibility; challenges with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nick Reed, PhD, MSc(OT), Principal investigator, Holland Bloorview Kids Rehabilitation Hospital/ Bloorview Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02257749
- Sponsor's protocol ID
- 13-459
- Status last verified
- Mar 2022
- First submitted
- 2 Oct 2014
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26231756
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Active Rehabilitation to a Comprehensive Education Intervention for Youth With Persistent Post-concussion Symptoms Following Concussion.
- ClinicalTrials.gov ID
- NCT02257749
- Acronym / sponsor ID
- 13-459
- Keywords
- Concussion, Persistent Symptoms, Children, Exercise, Adolescents, Active Rehabilitation, Education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: feasibility; challenges with recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Rehabilitation | Experimental | Other: Active Rehabilitation, Other: Comprehensive Education Intervention (Standard Care)Active Rehabilitation Intervention and Comprehensive Education Intervention (Standard Care) |
| Comprehensive Education Intervention | Active comparator | Other: Comprehensive Education Intervention (Standard Care)Comprehensive Education Intervention (Standard Care) only |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active RehabilitationThe 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. | Other | Active Rehabilitation |
| Comprehensive 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. | Other | Active Rehabilitation, Comprehensive Education Intervention |
Primary outcome
Post-Concussion Symptoms
Time frame: 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
Time frame: 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.
Post Concussion Symptoms
Time frame: Week 6 (upon completion of intervention)
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.
24 secondary outcomes
Mood
Time frame: Week 0 (Baseline)
Mood
Time frame: Week 6 (upon completion of the intervention)
Behavior
Time frame: Week 0 (Baseline)
Behavior
Time frame: Week 6 (upon completion of the intervention)
Energy Level
Time frame: Week 0 (Baseline)
Energy Level
Time frame: Week 6 (upon completion of the intervention)
Quality of Life Level
Time frame: Week 0 (Baseline)
Quality of Life Level
Time frame: Week 6 (upon completion of the intervention)
SCAT Balance
Time frame: Week 0 (Baseline)
Balance
Time frame: Week 0 (Baseline)
Balance
Time frame: Week 6 (upon completion of the intervention)
Neurocognitive
Time frame: Week 0 (Baseline)
Neurocognitive
Time frame: Week 6 (upon completion of the intervention)
Anxiety
Time frame: Week 0 (Baseline)
Anxiety
Time frame: Week 6 (upon completion of the intervention)
Activity Participation
Time frame: Week 0 (Baseline)
Satisfaction Level
Time frame: Week 0 (Baseline)
Acute Concussion Evaluation
Time frame: Week 0 (Baseline)
Occupational Performance
Time frame: Week 0 (Baseline)
Occupational Performance
Time frame: Week 6 (upon completion of the intervention)
Balance
Time frame: Week 6 (upon completion of intervention)
Activity Participation
Time frame: Week 6 (upon completion of the intervention)
Activity Participation
Time frame: Week 2
Satisfaction Level
Time frame: Week 6 (upon completion of the intervention)
Results and safety
The study was stopped early (reason given: feasibility; challenges with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Derived from this study: PubMed 26231756Reed 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nick Reed, PhD, MSc(OT) principal investigator
Holland Bloorview Kids Rehabilitation Hospital/ Bloorview Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Rehabilitation in people with Concussion and Sport-Related Concussion, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: feasibility; challenges with recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-Concussion Symptoms (time frame: Week 0 (Baseline)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02257749, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022; AzTrials last refreshed its copy on 27 Oct 2026.