Sport-related ConcussionNCT02031068
Exercise for Adolescents Following Sport-Related Concussion: A Randomized Control Trial
A study testing Active Rehabilitation Program and Treatment-as-usual (TAU) in people with Sport-related Concussion and Concussion, run by University of British Columbia at 1 site in Canada.
Trial summary
To test the safety and feasibility of a new treatment for adolescents who are slow to recover from a sport-related concussion, the investigators are conducting a randomised controlled trial comparing treatment as usual with an active rehabilitation program that involves sub-symptom threshold cardiac exertion… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Sport-related Concussion, Concussion, Mild Traumatic Brain Injury (MTBI)
- What is being tested?
- Active Rehabilitation Program and Treatment-as-usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Feb 2016
- 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 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Adolescents referred to G. F. Strong Rehabilitation Centre (GFS) for atypical recovery preventing them from entering standard return to activities protocols will be recruited on a voluntary basis to participate in this study.
Eligibility criteria for study entry are as follows:
- sustained an injury in sports,
- are 4 weeks post injury,
- report 2+ persistent post-concussion symptoms with no significant improvement over the past week,
- are between the ages of 14 and 18,
- have no developmental, congenital, or cognitive diagnoses,
- have no active mental health disorders,
- are able to attend at GFS,
- speak English as their dominant language,
- have no prior moderate or severe TBI,
- have no concussion in the 6 months before the present injury, and
- medical clearance by the study physician.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
GF Strong Rehabilitation Centre
Vancouver, British Columbia, V5Z 2G9
Catherine Chan, MPT, (604) 734-1313, Catherine.chan2@vch.ca
Catherine Chan, MPT
About this study
Official title: Active Rehabilitation for Slow to Recover Adolescents Following Sport-Related Concussion: A Randomized Control Trial
To test the safety and feasibility of a new treatment for adolescents who are slow to recover from a sport-related concussion, the investigators are conducting a randomised controlled trial comparing treatment as usual with an active rehabilitation program that involves sub-symptom threshold cardiac exertion, sport-specific coordination activities, and positive visualisation techniques.
Read the detailed description
Most adolescents recover within the first month following a sport-related concussion. However, some do not. Little is known about how to best facilitate recovery when symptoms do not resolve spontaneously and swiftly. Although active rehabilitation has been recently suggested as a promising means of promoting recovery, current literature does not provide adequate evidence for safe adaptation into clinical practice.
Objective: The purpose of this project is to evaluate an active rehabilitation protocol for adolescents who are slow to recover following sport-related concussion. Primary aims: to confirm the tolerability and safety of the active rehabilitation protocol as compared to treatment as usual controls. Secondary aims: 1) to document the impact of active rehabilitation on post-concussion symptoms and return to activity; 2) to explore the intervention effects on quality of life, mood, energy level, balance, cognitive functioning, and return to pre-injury activities.
Study design: A parallel group open label randomized comparison trial of 30 adolescents who are slow to recover following sport-related concussion. After initial screening and assessment, both groups will receive treatment as usual. Participants in the experimental group will also participate in sub-symptom threshold exercise, sport-specific coordination practice, and positive visualisation daily.
Outcome measures: The investigators will monitor for adverse events and assess post-concussion symptoms throughout the study as a primary marker of recovery. The investigators will also report secondary outcomes such as quality of life, mood, energy level, balance and cognitive functioning. Finally the investigators will record rates of return to school (full time, part time) and rates of return to sport (regular pre-injury vs. modified level). As a result, clinicians will be able to follow a new rehabilitation protocol in a safe and meaningful way. Lastly, research findings will be disseminated in the form of a publication, at conferences, and via in-services.
Hypotheses:
1a. The drop-out rate will be comparable in the groups receiving treatment-as-usual (TAU) only versus TAU plus active rehabilitation.
1b. Adverse events occurring outside of the clinic will be comparable in the groups receiving TAU only versus TAU plus active rehabilitation.
1c. For the group receiving active rehabilitation, symptom exacerbations in the in-clinic exercise sessions will resolve within 30 minutes.
- Participants receiving active rehabilitation will report greater improvement of post-concussion symptoms (primary outcome) at follow-up.
- Participants receiving active rehabilitation will report higher quality of life, fewer depressive symptoms, and higher energy levels; demonstrate better balance and neuropsychological performance at follow-up; and return to their pre-injury activities at higher rates.
- Being tested
- Active Rehabilitation Program, Treatment-as-usual (TAU)
- Keywords
- active rehabilitation, exercise, concussion
- 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 Rehabilitation ProgramBehavioural
The active rehabilitation program will be implemented for a maximum of 6-8 weeks. Each participant will be followed by regular weekly telephone calls or personal follow-up relating to outcome from concussion and managing symptoms. The participant will receive TAU (above) in addition to the 4 components listed below:
- Sub-maximal aerobic training for up to 15 minutes
- Light coordination and sport-specific exercises for up to 10 minutes
- Visualization and imagery techniques
- Home program
A physiotherapist will supervise the rehabilitation.
Treatment-as-usual (TAU)Behavioural
The TAU program will be implemented after the initial assessment. It will consist of 2 components:
An initial education session by an occupational therapist, relating to outcome from concussion and managing symptoms A school consultation to provide teacher education, recommend accommodations, and facilitate return to school
| Study group | Role | What they receive |
|---|---|---|
| Treatment-as-usual (TAU) | Active comparator | The TAU program will be implemented after the initial assessment. It will consist of 2 components:
1. An initial education session by an occupational therapist, relating to outcome from concussion and managing symptoms
2. A school consultation to provide teacher education, recommend accommodations, and facilitate return to school Receives: Behavioral: Treatment-as-usual (TAU) |
| Behavioral:Active Rehabilitation Program | Experimental | The active rehabilitation program will be implemented for a maximum of 6-8 weeks. Each participant will be followed by regular weekly telephone calls or personal follow-up relating to outcome from concussion and managing symptoms. The participant will receive TAU (above) in addition to the 4 components listed below:
1. Sub-maximal aerobic training for up to 15 minutes
2. Light coordination and sport-specific exercises for up to 10 minutes
3. Visualization and imagery techniques
4. Home program.
A physiotherapist will supervise the rehabilitation. Receives: Behavioral: Active Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom Report
The Post-Concussion Scale consists of 22 subjectively-experienced symptoms (e.g., headache, dizziness, concentration problems, and fogginess). A total score is derived from this 22-item scale. Athletes report symptoms based on the severity of each symptom that day, allowing tracking of symptoms over very short intervals
Measured: Baseline
Symptom Report
Measured: At 8 weeks (end-of-treatment)
Secondary outcomes (10)
Mood
The Beck Depression Inventory for Youth-Second Edition is a 20-item depression screening test designed for children and adolescents.
Measured: Baseline
Energy level
Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale will be used to monitor fatigue in the study participants, another commonly reported complaint after a MTBI. The PedsQL was designed to measure fatigue in pediatric patients; it includes a General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items), and Cognitive Fatigue Scale (6 items).
Measured: Baseline
Balance Testing
The Balance Error Scoring System (BESS) is a commonly used measure of static balance and postural stability. The test is rapid, relatively easy-to-administer, and inexpensive. A combination of three stances (narrow double leg stance; single leg stance; and tandem stance) and footing surfaces (firm surface/floor or medium density foam) are used for the test. Each stance is held, with hands on hips and eyes closed, for 20 seconds. "Error" points are given for specific behaviors, including opening eyes, lifting hands off hips, or stepping, stumbling, or falling.
Safety Issue: Falls and fall-related injuries. Testing will be supervised by a registered physiotherapist.
Measured: Baseline
Neurocognitive Testing
ImPACT is a computerized neuropsychological test battery that consists of six individual test modules that measure multiple aspects of cognitive functioning including attention, memory, working memory, visual scanning, reaction time, and processing speed. The test takes 20-25 minutes. Four composite (i.e., summary) scores are tabulated based upon these individual test scores: Verbal Memory, Visual Memory, Reaction Time, and Processing Speed.
Measured: Baseline
Return to School and Sport
Number of days away from school and sports will be documented. School status will also be rated as part-time, full-time, and with/without accommodations at different time intervals.
Measured: Baseline
Mood
The Beck Depression Inventory for Youth-Second Edition will be used
Measured: At 8 weeks (end-of-treatment)
Energy level
Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale will be used
Measured: At 8 weeks (end-of-treatment)
Balance Testing
The Balance Error Scoring System (BESS) will be used
Measured: At 8 weeks (end-of-treatment)
Neurocognitive Testing
ImPACT will be used.
Measured: At 8 weeks (end-of-treatment)
Return to School and Sport
Number of days away from school and sports will be documented. School status will also be rated as part-time, full-time, and with/without accommodations at different time intervals.
Measured: At 8 weeks (end-of-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
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 Sport-related ConcussionStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Chan, Physiotherapy, Principal investigator, GF Strong Rehab Centre - Vancouver Coastal Health Research InstituteGrant Iverson, Ph.D, Principal investigator, University of British Columbia, Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031068
- Sponsor's protocol ID
- H12-01780
- Status last verified
- Apr 2015
- First submitted
- 10 Dec 2013
- Last updated
- 8 Apr 2015
- Results posted
- No
Publications
Chan C, Iverson GL, Purtzki J, Wong K, Kwan V, Gagnon I, Silverberg ND. Safety of Active Rehabilitation for Persistent Symptoms After Pediatric Sport-Related Concussion: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):242-249. doi: 10.1016/j.apmr.2017.09.108. Epub 2017 Oct 5.
PubMed 28989074
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Active Rehabilitation for Slow to Recover Adolescents Following Sport-Related Concussion: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02031068
- Acronym / sponsor ID
- H12-01780
- Keywords
- active rehabilitation, exercise, concussion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 9 Jan 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.
To test the safety and feasibility of a new treatment for adolescents who are slow to recover from a sport-related concussion, the investigators are conducting a randomised controlled trial comparing treatment as usual with an active rehabilitation program that involves sub-symptom threshold cardiac exertion, sport-specific coordination activities, and positive visualisation techniques.
Detailed description
Most adolescents recover within the first month following a sport-related concussion. However, some do not. Little is known about how to best facilitate recovery when symptoms do not resolve spontaneously and swiftly. Although active rehabilitation has been recently suggested as a promising means of promoting recovery, current literature does not provide adequate evidence for safe adaptation into clinical practice.
Objective: The purpose of this project is to evaluate an active rehabilitation protocol for adolescents who are slow to recover following sport-related concussion. Primary aims: to confirm the tolerability and safety of the active rehabilitation protocol as compared to treatment as usual controls. Secondary aims: 1) to document the impact of active rehabilitation on post-concussion symptoms and return to activity; 2) to explore the intervention effects on quality of life, mood, energy level, balance, cognitive functioning, and return to pre-injury activities.
Study design: A parallel group open label randomized comparison trial of 30 adolescents who are slow to recover following sport-related concussion. After initial screening and assessment, both groups will receive treatment as usual. Participants in the experimental group will also participate in sub-symptom threshold exercise, sport-specific coordination practice, and positive visualisation daily.
Outcome measures: The investigators will monitor for adverse events and assess post-concussion symptoms throughout the study as a primary marker of recovery. The investigators will also report secondary outcomes such as quality of life, mood, energy level, balance and cognitive functioning. Finally the investigators will record rates of return to school (full time, part time) and rates of return to sport (regular pre-injury vs. modified level). As a result, clinicians will be able to follow a new rehabilitation protocol in a safe and meaningful way. Lastly, research findings will be disseminated in the form of a publication, at conferences, and via in-services.
Hypotheses:
1a. The drop-out rate will be comparable in the groups receiving treatment-as-usual (TAU) only versus TAU plus active rehabilitation.
1b. Adverse events occurring outside of the clinic will be comparable in the groups receiving TAU only versus TAU plus active rehabilitation.
1c. For the group receiving active rehabilitation, symptom exacerbations in the in-clinic exercise sessions will resolve within 30 minutes.
- Participants receiving active rehabilitation will report greater improvement of post-concussion symptoms (primary outcome) at follow-up.
- Participants receiving active rehabilitation will report higher quality of life, fewer depressive symptoms, and higher energy levels; demonstrate better balance and neuropsychological performance at follow-up; and return to their pre-injury activities at higher rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment-as-usual (TAU) | Active comparator | Behavioral: Treatment-as-usual (TAU)The TAU program will be implemented after the initial assessment. It will consist of 2 components: 1. An initial education session by an occupational therapist, relating to outcome from concussion and managing symptoms 2. A school consultation to provide teacher education, recommend accommodations, and facilitate return to school |
| Behavioral:Active Rehabilitation Program | Experimental | Behavioral: Active Rehabilitation ProgramThe active rehabilitation program will be implemented for a maximum of 6-8 weeks. Each participant will be followed by regular weekly telephone calls or personal follow-up relating to outcome from concussion and managing symptoms. The participant will receive TAU (above) in addition to the 4 components listed below: 1. Sub-maximal aerobic training for up to 15 minutes 2. Light coordination and sport-specific exercises for up to 10 minutes 3. Visualization and imagery techniques 4. Home program. A physiotherapist will supervise the rehabilitation. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 Rehabilitation ProgramThe active rehabilitation program will be implemented for a maximum of 6-8 weeks. Each participant will be followed by regular weekly telephone calls or personal follow-up relating to outcome from concussion and managing symptoms. The participant will receive TAU (above) in addition to the 4 components listed below: 1. Sub-maximal aerobic training for up to 15 minutes 2. Light coordination and sport-specific exercises for up to 10 minutes 3. Visualization and imagery techniques 4. Home program A physiotherapist will supervise the rehabilitation. | Behavioural | Behavioral:Active Rehabilitation Program |
| Treatment-as-usual (TAU)The TAU program will be implemented after the initial assessment. It will consist of 2 components: An initial education session by an occupational therapist, relating to outcome from concussion and managing symptoms A school consultation to provide teacher education, recommend accommodations, and facilitate return to school | Behavioural | Treatment-as-usual (TAU) |
Primary outcome
Symptom Report
Time frame: Baseline
The Post-Concussion Scale consists of 22 subjectively-experienced symptoms (e.g., headache, dizziness, concentration problems, and fogginess). A total score is derived from this 22-item scale. Athletes report symptoms based on the severity of each symptom that day, allowing tracking of symptoms over very short intervals
Symptom Report
Time frame: At 8 weeks (end-of-treatment)
10 secondary outcomes
Mood
Time frame: Baseline
Energy level
Time frame: Baseline
Balance Testing
Time frame: Baseline
Neurocognitive Testing
Time frame: Baseline
Return to School and Sport
Time frame: Baseline
Mood
Time frame: At 8 weeks (end-of-treatment)
Energy level
Time frame: At 8 weeks (end-of-treatment)
Balance Testing
Time frame: At 8 weeks (end-of-treatment)
Neurocognitive Testing
Time frame: At 8 weeks (end-of-treatment)
Return to School and Sport
Time frame: At 8 weeks (end-of-treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
- Derived from this study: PubMed 28989074Chan C, Iverson GL, Purtzki J, Wong K, Kwan V, Gagnon I, Silverberg ND. Safety of Active Rehabilitation for Persistent Symptoms After Pediatric Sport-Related Concussion: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):242-249. doi: 10.1016/j.apmr.2017.09.108. Epub 2017 Oct 5.
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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.
Catherine Chan, Physiotherapy principal investigator
GF Strong Rehab Centre - Vancouver Coastal Health Research Institute
Grant Iverson, Ph.D principal investigator
University of British Columbia, Department of Psychiatry
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 Program and Treatment-as-usual (TAU) in people with Sport-related Concussion and Concussion, run by University of British Columbia 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?
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: status not confirmed, as of the sponsor's last update on 8 Apr 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Chan, MPT ((604) 734-1313, Catherine.chan2@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Report (time frame: Baseline). The study lists 2 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 NCT02031068, 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 8 Apr 2015.