ConcussionNCT02988323
Cervicovestibular Physiotherapy and Aerobic Exercise in Concussion
A study testing Cervicovestibular Physio (CV PT), Low-Level Aerobic Exercise (LLAE) and Combination (LLAE and CV PT) in people with Concussion, run by Sport Injury Prevention Research Centre.
Trial summary
Sport concussions are among the most commonly occurring injuries in sport and recreation and pose significant public health implications for Canadians. Many individuals who sustain a concussion recover in the initial 7-10 days but up to 74% of youth and 31% of adults may suffer from persistent symptoms. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Concussion
- What is being tested?
- Cervicovestibular Physio (CV PT), Low-Level Aerobic Exercise (LLAE) and Combination (LLAE and CV PT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Mar 2018
- 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
- Ages 10-18 years of age
- Diagnosed by the study sport medicine physician with a sport related concussion as per the 4th International Consensus guidelines
- Persistent symptoms of dizziness, neck pain and/or headaches (>10 days and less than one year post injury) reported on the Sport Concussion Assessment Tool 3 (SCAT3) at initial or follow-up visit to the study sport medicine physician
- Clinical findings suggesting cervical spine and/or vestibular involvement (i.e. limitations in cervical range of motion, positive clinical tests suggesting cervicogenic headaches, altered patterns of neuromotor control, alterations on dynamic visual acuity, dynamic balance, motion sensitivity, positive test for BPPV, etc)
Who cannot join
- • Inability to participate in physical activity for a reason other than sport related concussion
- Inability to communicate in English language
- Neurodevelopmental delays
- Other orthopaedic injury affecting ability to participate
- Medication known to affect neural adaptation as they may alter the response to treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cervicovestibular Rehabilitation and Aerobic Exercise in Children and Youth With Persistent Symptoms Following a Sport-related Concussion: A Randomized Controlled Trial.
Sport concussions are among the most commonly occurring injuries in sport and recreation and pose significant public health implications for Canadians. Many individuals who sustain a concussion recover in the initial 7-10 days but up to 74% of youth and 31% of adults may suffer from persistent symptoms. Little research is currently available evaluating the effects of treatment for individuals who are slower to recover following sport-related concussion. An initial RCT identified a significant treatment effect in individuals with persistent symptoms of dizziness, neck pain and/or headaches following sport-related concussion when treated with a combination of cervical and vestibular physiotherapy compared to a typical protocol of rest followed by graded exertion (Schneider et al, 2014). Low level aerobic exercise in combination with sport specific training may also be of benefit to facilitate recovery in children and youth following concussion (Gagnon et al, 2009, 2016). Further evaluation of these treatments is required to better understand the effects of each treatment in isolation and in combination. This trial will have the ability to inform future multifaceted clinical trials as well as clinical practice. Ultimately, identification of optimal treatment paradigms will lead to a decrease in persistent symptoms and functional alterations in children and youth from this commonly occurring injury.
Read the detailed description
Although awareness regarding sport-related concussion is growing, rehabilitative strategies for this commonly occuring injury have been a focus of very little research. With the exception of our pilot RCT, no RCTs to date have evaluated the efficacy of cervical spine physiotherapy in combination with vestibular rehabilitation in sport-related concussion. Current evidence has suggested positive effects of low-level aerobic exercise in youth and adults who are slow to recover following a concussion (Gagnon et al, 2016). However, low-level aerobic exercise has not yet been compared to cervicovestibular physiotherapy. A shift in clinical practice (to implement cervicovestibular physiotherapy or low level aerobic exercise) is occurring, but a direct comparison of the effects of low level aerobic exercise and multimodal physiotherapy treatment has not yet been conducted. A combination of these two forms of treatment may be more beneficial than either in isolation. Thus, the combination of physiotherapy and low level aerobic exercise treatment also requires evaluation. Identification of management strategies for individuals with persistent symptoms following concussion is urgently required to inform practice and optimize treatment strategies in this commonly occuring health problem.
OBJECTIVES:
Primary Research Question:
- Does cervical and vestibular rehabilitation (CVPT) 1) result in a greater proportion of individuals medically cleared to return to sport (yes/no); 2) improve quality of life compared to a control group of low level aerobic exercise (LLAE) (following an 8-week intervention in individuals with persistent symptoms of dizziness, neck pain and/or headaches following concussion)?
Secondary Research Questions:
- Does a combination of CVPT and LLAE 1) result in a greater proportion of individuals medically cleared to return to sport; 2) Improve quality of life compared to CVPT or LLAE alone (following an 8-week intervention in individuals with persistent symptoms of dizziness, neck pain and/or headaches following concussion)?
Exploratory Research Questions:
- Does cervical and vestibular rehabilitation (CVPT) result in a greater proportion of individuals medically cleared to return to sport compared to a control group of low level aerobic exercise (LLAE) (following an 8-week intervention in individuals with persistent symptoms of dizziness, neck pain and/or headaches following concussion) when stratified by subgroups based on time since injury, previous history of concussion, sex and age?
- Does a combination of CVPT and LLAE result in a greater proportion of individuals medically cleared to return to sport compared to CVPT or LLAE alone when stratified by subgroups based on time since injury, previous history of concussion, sex and age?
- What clinical characteristics predict response to treatment?
- What changes in symptoms and clinical measures of cervical and vestibular function occur with treatment?
- What changes in measures of disability, self-efficacy, neuropsychological and psychosocial function occur with treatment?
- What other factors may affect treatment outcome (i.e. medical clearance) and quality of life in youth with persisting symptoms following concussion?
METHODS:
The study design is a single blind randomized controlled trial (RCT). Participants will be recruited through the University of Calgary Acute Sport Concussion Clinic and through community sport medicine offices, family physicians and allied health in the City of Calgary and surrounding areas.
All participants will undergo an initial physiotherapy assessment at inclusion into the study. This assessment will be repeated at the time of medical clearance to return to sport (if less than 8 weeks) or at 8 weeks following initiation of treatment. Participants will be randomized into a cervicovestibular physiotherapy intervention (CVPT) group, a low level aerobic exercise group (LLAE), or a combination of cervicovestibular physiotherapy and low level aerobic exercise group (combination). All study participants will meet weekly (30 minute appointment) with a study physiotherapist for eight weeks (or until the time of medical clearance to return to sport if clearance occurs prior to 8 weeks). All groups will follow a protocol of graded exertion as per the 4th International Consensus Guidelines (Zurich 2012, McCrory et al, 2013).
- Conditions
- Concussion
- Being tested
- Cervicovestibular Physio (CV PT), Low-Level Aerobic Exercise (LLAE), Combination (LLAE and CV PT)
- Keywords
- sport concussion, cervical spine, vestibular rehabilitation, exercise, rehabilitation, children, youth
- 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.
Cervicovestibular Physio (CV PT)Other
See description in CVPT arm
Low-Level Aerobic Exercise (LLAE)Other
See description in LLAE arm
Combination (LLAE and CV PT)Other
See description in LLAE and CVPT arm
| Study group | Role | What they receive |
|---|---|---|
| Cervicovestibular Physio (CV PT) | Experimental | In addition to the standard protocol of rest followed by exertion, the CV PT group will participate in a combination of cervical spine and vestibular rehabilitation as per a standardized treatment algorithm based on individual assessment findings. This form of therapy combines treatment techniques for both the cervical spine and vestibular system that are commonly used in physiotherapy practice. Cervical spine treatments may include neuromotor retraining, sensorimotor retraining, manual therapy, soft tissue techniques, and range of motion exercises. Vestibular rehabilitation may include gaze stabilization, habituation, standing balance, dynamic balance and canalith repositioning maneouvers. Receives: Other: Cervicovestibular Physio (CV PT) |
| Low-Level Aerobic Exercise (LLAE) | Experimental | Participants will exercise at 60% maximum heart rate for 15 minutes. This heart rate will be calculated by taking 220-age (in years) and multiplying by 0.6 to determine the target heart rate while performing the low level aerobic exercise. Aerobic exercises may include treadmill, walking or stationary cycling. Exercise will be performed 5-6 times per week independently at home and monitored by their parents. Individuals will be taught how to monitor their heart rate. This protocol has previously been found to be feasible and of minimal risk to participants. Receives: Other: Low-Level Aerobic Exercise (LLAE) |
| Combination (LLAE and CV PT) | Other | The combination group will complete a protocol that includes both the cervicovestibular physiotherapy and LLAE interventions described above. As described above, the study participants will be seen once weekly by the study physiotherapist for CV PT and also complete a protocol of LLAE at home. Receives: Other: Combination (LLAE and CV PT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Clearance to return to sport
The primary outcomes of interest will be: 1) Medical clearance to return to sport by 8-weeks (as per the 4th International Consensus Guidelines on Concussion in Sport). Medical clearance was selected because it is the most clinically relevant measure and will reflect not only symptom resolution but also functional improvement. We have chosen to further standardize this outcome as follows to minimize risk of bias:
- Asymptomatic a rest
- Able to complete all steps of the return to play protocol with no recurrence of symptoms
- Able to return to school full time without accommodations
- No other clinical findings suggesting an inability to return to play Some individuals may choose not to return to sport (i.e. retire) or to have coaching decisions influence their return to sport (i.e. may return prior to medical clearance). Therefore, medical clearance to return to sport (as opposed to actual return) is felt to most accurately reflect recovery.
Measured: 8 weeks
Pediatric Quality of Life
Paediatric Quality of Life Inventory (Peds-QL): The Pediatric Quality of Life Scale (PedsQL) is a measure of quality of life that is specific to children and measures four health domains including: Physical, emotional, social and school functioning. It is a measure that has demonstrated reliability and validity in multiple disease types in children, including traumatic brain injury.
Measured: Change from Initial assessment to 8 weeks
Secondary outcomes (27)
Sport Multidimensional Perfectionism Scale-2
Measured: Change from Initial assessment to 8 weeks
Connor-Davidson Resilience Scale
Measured: Change from Initial assessment to 8 weeks
K6 Scale
The K6 scale is a 6-item rating scale designed to assess psychological distress. It was developed with support from the U.S. government's National Center for Health Statistics for use in the redesigned U.S. National Health Interview Survey (NHIS). As described in more detail in Kessler et al. (2003), the scale was designed to be sensitive around the threshold for the clinically significant range of the distribution of nonspecific distress in an effort to maximize the ability to discriminate cases of serious mental illness (SMI) from non-cases.
Measured: Change from Initial assessment to 8 weeks
Supplemental Questions (Mrazick)
Questions related to distress about injury at the time of injury, time of assessment and belief to make a full recovery rated on a 0-10 point scale
Measured: Change from Initial assessment to 8 weeks
Self-efficacy questionnaire for children (Gagnon et al, 2009)
Measured: Change from Initial assessment to 8 weeks
Global Rating of Change
Measured: Change from Initial assessment to 8 weeks
Numeric Pain Rating Scale (Neck Pain)
Neck pain rating from 0-10
Measured: Change from Initial assessment to 8 weeks
Numeric Pain Rating Scale (Headache)
Headache rating from 0-10
Measured: Change from Initial assessment to 8 weeks
Numeric Dizziness Rating Scale
Dizziness rating from 0-10
Measured: Change from Initial assessment to 8 weeks
Patient Specific Functional Scale (PSFS)
Measured: Change from Initial assessment to 8 weeks
Activities-specific Balance Confidence Scale
Measured: Change from Initial assessment to 8 weeks
Dizziness Handicap Inventory
Measured: Change from Initial assessment to 8 weeks
Sport Concussion Assessment Tool 3
Measured: Change from Initial assessment to 8 weeks
Dynamic Visual Acuity
Clinical test of dynamic visual acuity using ETDRS
Measured: Change from Initial assessment to 8 weeks
Balance Error Scoring System
Measured: Change from Initial assessment to 8 weeks
Functional Gait Assessment
10 item standardized test of dynamic balance
Measured: Change from Initial assessment to 8 weeks
Head Thrust Test
Measured: Change from Initial assessment to 8 weeks
Motion Sensitivity Test
Measured: Change from Initial assessment to 8 weeks
Cervical Flexor Endurance
Standardized test of cervical flexor endurance measured in seconds
Measured: Change from Initial assessment to 8 weeks
Cervical Flexion Rotation Test (CFRT)
Measured: Change from Initial assessment to 8 weeks
Palpation for Segmental Tenderness (PST)
As per Schneider et al 2014, palpation for segmental tenderness in cervical spine
Measured: Change from Initial assessment to 8 weeks
Cervical Rotation Side Flexion Test
Measured: Change from Initial assessment to 8 weeks
Joint Position Error (JPE)
Measured: Change from Initial assessment to 8 weeks
Walk While Talking Test
Measured: Change from Initial assessment to 8 weeks
Vestibular/Ocular Motor Screen (VOMS)
As per Mucha et al, 2014
Measured: Change from Initial assessment to 8 weeks
Manual Spinal Examination (MSE)
As per Schneider et al, 2014
Measured: Change from Initial assessment to 8 weeks
Actigraphy
Use of a waist worn activity monitor to validly measure the amount of physical activity that an individual performs throughout their day.
Measured: Change from Initial Assessment to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)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
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sport Injury Prevention Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary
- Responsible party
- Principal investigator, KSchneider, Sport Injury Prevention Research Centre
- Investigators
- Kathryn Schneider, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988323
- Sponsor's protocol ID
- Conc-PT-02
- Status last verified
- Dec 2016
- First submitted
- 12 Oct 2016
- Last updated
- 9 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
McCrory P, Meeuwisse WH, Aubry M, Cantu RC, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen R, Guskiewicz KM, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport, Zurich, November 2012. J Athl Train. 2013 Jul-Aug;48(4):554-75. doi: 10.4085/1062-6050-48.4.05. No abstract available.
PubMed 23855364Gagnon I, Galli C, Friedman D, Grilli L, Iverson GL. Active rehabilitation for children who are slow to recover following sport-related concussion. Brain Inj. 2009 Nov;23(12):956-64. doi: 10.3109/02699050903373477.
PubMed 19831492Schneider KJ, Meeuwisse WH, Nettel-Aguirre A, Barlow K, Boyd L, Kang J, Emery CA. Cervicovestibular rehabilitation in sport-related concussion: a randomised controlled trial. Br J Sports Med. 2014 Sep;48(17):1294-8. doi: 10.1136/bjsports-2013-093267. Epub 2014 May 22.
PubMed 24855132Schneider KJ, Iverson GL, Emery CA, McCrory P, Herring SA, Meeuwisse WH. The effects of rest and treatment following sport-related concussion: a systematic review of the literature. Br J Sports Med. 2013 Apr;47(5):304-7. doi: 10.1136/bjsports-2013-092190.
PubMed 23479489Gagnon I, Grilli L, Friedman D, Iverson GL. A pilot study of active rehabilitation for adolescents who are slow to recover from sport-related concussion. Scand J Med Sci Sports. 2016 Mar;26(3):299-306. doi: 10.1111/sms.12441. Epub 2015 Mar 3.
PubMed 25735821
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervicovestibular Rehabilitation and Aerobic Exercise in Children and Youth With Persistent Symptoms Following a Sport-related Concussion: A Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT02988323
- Acronym / sponsor ID
- Conc-PT-02
- Conditions
- Concussion
- Keywords
- sport concussion, cervical spine, vestibular rehabilitation, exercise, rehabilitation, children, youth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Sport Injury Prevention Research CentreUniversity, hospital or other
- Collaborators
- University of Calgary
- Study start
- Dec 2016
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 9 Dec 2016 (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.
Sport concussions are among the most commonly occurring injuries in sport and recreation and pose significant public health implications for Canadians. Many individuals who sustain a concussion recover in the initial 7-10 days but up to 74% of youth and 31% of adults may suffer from persistent symptoms. Little research is currently available evaluating the effects of treatment for individuals who are slower to recover following sport-related concussion. An initial RCT identified a significant treatment effect in individuals with persistent symptoms of dizziness, neck pain and/or headaches following sport-related concussion when treated with a combination of cervical and vestibular physiotherapy compared to a typical protocol of rest followed by graded exertion (Schneider et al, 2014). Low level aerobic exercise in combination with sport specific training may also be of benefit to facilitate recovery in children and youth following concussion (Gagnon et al, 2009, 2016). Further evaluation of these treatments is required to better understand the effects of each treatment in isolation and in combination. This trial will have the ability to inform future multifaceted clinical trials as well as clinical practice. Ultimately, identification of optimal treatment paradigms will lead to a decrease in persistent symptoms and functional alterations in children and youth from this commonly occurring injury.
Detailed description
Although awareness regarding sport-related concussion is growing, rehabilitative strategies for this commonly occuring injury have been a focus of very little research. With the exception of our pilot RCT, no RCTs to date have evaluated the efficacy of cervical spine physiotherapy in combination with vestibular rehabilitation in sport-related concussion. Current evidence has suggested positive effects of low-level aerobic exercise in youth and adults who are slow to recover following a concussion (Gagnon et al, 2016). However, low-level aerobic exercise has not yet been compared to cervicovestibular physiotherapy. A shift in clinical practice (to implement cervicovestibular physiotherapy or low level aerobic exercise) is occurring, but a direct comparison of the effects of low level aerobic exercise and multimodal physiotherapy treatment has not yet been conducted. A combination of these two forms of treatment may be more beneficial than either in isolation. Thus, the combination of physiotherapy and low level aerobic exercise treatment also requires evaluation. Identification of management strategies for individuals with persistent symptoms following concussion is urgently required to inform practice and optimize treatment strategies in this commonly occuring health problem.
OBJECTIVES:
Primary Research Question:
- Does cervical and vestibular rehabilitation (CVPT) 1) result in a greater proportion of individuals medically cleared to return to sport (yes/no); 2) improve quality of life compared to a control group of low level aerobic exercise (LLAE) (following an 8-week intervention in individuals with persistent symptoms of dizziness, neck pain and/or headaches following concussion)?
Secondary Research Questions:
- Does a combination of CVPT and LLAE 1) result in a greater proportion of individuals medically cleared to return to sport; 2) Improve quality of life compared to CVPT or LLAE alone (following an 8-week intervention in individuals with persistent symptoms of dizziness, neck pain and/or headaches following concussion)?
Exploratory Research Questions:
- Does cervical and vestibular rehabilitation (CVPT) result in a greater proportion of individuals medically cleared to return to sport compared to a control group of low level aerobic exercise (LLAE) (following an 8-week intervention in individuals with persistent symptoms of dizziness, neck pain and/or headaches following concussion) when stratified by subgroups based on time since injury, previous history of concussion, sex and age?
- Does a combination of CVPT and LLAE result in a greater proportion of individuals medically cleared to return to sport compared to CVPT or LLAE alone when stratified by subgroups based on time since injury, previous history of concussion, sex and age?
- What clinical characteristics predict response to treatment?
- What changes in symptoms and clinical measures of cervical and vestibular function occur with treatment?
- What changes in measures of disability, self-efficacy, neuropsychological and psychosocial function occur with treatment?
- What other factors may affect treatment outcome (i.e. medical clearance) and quality of life in youth with persisting symptoms following concussion?
METHODS:
The study design is a single blind randomized controlled trial (RCT). Participants will be recruited through the University of Calgary Acute Sport Concussion Clinic and through community sport medicine offices, family physicians and allied health in the City of Calgary and surrounding areas.
All participants will undergo an initial physiotherapy assessment at inclusion into the study. This assessment will be repeated at the time of medical clearance to return to sport (if less than 8 weeks) or at 8 weeks following initiation of treatment. Participants will be randomized into a cervicovestibular physiotherapy intervention (CVPT) group, a low level aerobic exercise group (LLAE), or a combination of cervicovestibular physiotherapy and low level aerobic exercise group (combination). All study participants will meet weekly (30 minute appointment) with a study physiotherapist for eight weeks (or until the time of medical clearance to return to sport if clearance occurs prior to 8 weeks). All groups will follow a protocol of graded exertion as per the 4th International Consensus Guidelines (Zurich 2012, McCrory et al, 2013).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cervicovestibular Physio (CV PT) | Experimental | Other: Cervicovestibular Physio (CV PT)In addition to the standard protocol of rest followed by exertion, the CV PT group will participate in a combination of cervical spine and vestibular rehabilitation as per a standardized treatment algorithm based on individual assessment findings. This form of therapy combines treatment techniques for both the cervical spine and vestibular system that are commonly used in physiotherapy practice. Cervical spine treatments may include neuromotor retraining, sensorimotor retraining, manual therapy, soft tissue techniques, and range of motion exercises. Vestibular rehabilitation may include gaze stabilization, habituation, standing balance, dynamic balance and canalith repositioning maneouvers. |
| Low-Level Aerobic Exercise (LLAE) | Experimental | Other: Low-Level Aerobic Exercise (LLAE)Participants will exercise at 60% maximum heart rate for 15 minutes. This heart rate will be calculated by taking 220-age (in years) and multiplying by 0.6 to determine the target heart rate while performing the low level aerobic exercise. Aerobic exercises may include treadmill, walking or stationary cycling. Exercise will be performed 5-6 times per week independently at home and monitored by their parents. Individuals will be taught how to monitor their heart rate. This protocol has previously been found to be feasible and of minimal risk to participants. |
| Combination (LLAE and CV PT) | Other | Other: Combination (LLAE and CV PT)The combination group will complete a protocol that includes both the cervicovestibular physiotherapy and LLAE interventions described above. As described above, the study participants will be seen once weekly by the study physiotherapist for CV PT and also complete a protocol of LLAE at home. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
- • Inability to participate in physical activity for a reason other than sport related concussion
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 |
|---|---|---|
| Cervicovestibular Physio (CV PT)See description in CVPT arm | Other | Cervicovestibular Physio (CV PT) |
| Low-Level Aerobic Exercise (LLAE)See description in LLAE arm | Other | Low-Level Aerobic Exercise (LLAE) |
| Combination (LLAE and CV PT)See description in LLAE and CVPT arm | Other | Combination (LLAE and CV PT) |
Primary outcome
Medical Clearance to return to sport
Time frame: 8 weeks
The primary outcomes of interest will be: 1) Medical clearance to return to sport by 8-weeks (as per the 4th International Consensus Guidelines on Concussion in Sport). Medical clearance was selected because it is the most clinically relevant measure and will reflect not only symptom resolution but also functional improvement. We have chosen to further standardize this outcome as follows to minimize risk of bias: 1. Asymptomatic a rest 2. Able to complete all steps of the return to play protocol with no recurrence of symptoms 3. Able to return to school full time without accommodations 4. No other clinical findings suggesting an inability to return to play Some individuals may choose not to return to sport (i.e. retire) or to have coaching decisions influence their return to sport (i.e. may return prior to medical clearance). Therefore, medical clearance to return to sport (as opposed to actual return) is felt to most accurately reflect recovery.
Pediatric Quality of Life
Time frame: Change from Initial assessment to 8 weeks
Paediatric Quality of Life Inventory (Peds-QL): The Pediatric Quality of Life Scale (PedsQL) is a measure of quality of life that is specific to children and measures four health domains including: Physical, emotional, social and school functioning. It is a measure that has demonstrated reliability and validity in multiple disease types in children, including traumatic brain injury.
27 secondary outcomes
Sport Multidimensional Perfectionism Scale-2
Time frame: Change from Initial assessment to 8 weeks
Connor-Davidson Resilience Scale
Time frame: Change from Initial assessment to 8 weeks
K6 Scale
Time frame: Change from Initial assessment to 8 weeks
Supplemental Questions (Mrazick)
Time frame: Change from Initial assessment to 8 weeks
Self-efficacy questionnaire for children (Gagnon et al, 2009)
Time frame: Change from Initial assessment to 8 weeks
Global Rating of Change
Time frame: Change from Initial assessment to 8 weeks
Numeric Pain Rating Scale (Neck Pain)
Time frame: Change from Initial assessment to 8 weeks
Numeric Pain Rating Scale (Headache)
Time frame: Change from Initial assessment to 8 weeks
Numeric Dizziness Rating Scale
Time frame: Change from Initial assessment to 8 weeks
Patient Specific Functional Scale (PSFS)
Time frame: Change from Initial assessment to 8 weeks
Activities-specific Balance Confidence Scale
Time frame: Change from Initial assessment to 8 weeks
Dizziness Handicap Inventory
Time frame: Change from Initial assessment to 8 weeks
Sport Concussion Assessment Tool 3
Time frame: Change from Initial assessment to 8 weeks
Dynamic Visual Acuity
Time frame: Change from Initial assessment to 8 weeks
Balance Error Scoring System
Time frame: Change from Initial assessment to 8 weeks
Functional Gait Assessment
Time frame: Change from Initial assessment to 8 weeks
Head Thrust Test
Time frame: Change from Initial assessment to 8 weeks
Motion Sensitivity Test
Time frame: Change from Initial assessment to 8 weeks
Cervical Flexor Endurance
Time frame: Change from Initial assessment to 8 weeks
Cervical Flexion Rotation Test (CFRT)
Time frame: Change from Initial assessment to 8 weeks
Palpation for Segmental Tenderness (PST)
Time frame: Change from Initial assessment to 8 weeks
Cervical Rotation Side Flexion Test
Time frame: Change from Initial assessment to 8 weeks
Joint Position Error (JPE)
Time frame: Change from Initial assessment to 8 weeks
Walk While Talking Test
Time frame: Change from Initial assessment to 8 weeks
Vestibular/Ocular Motor Screen (VOMS)
Time frame: Change from Initial assessment to 8 weeks
Manual Spinal Examination (MSE)
Time frame: Change from Initial assessment to 8 weeks
Actigraphy
Time frame: Change from Initial Assessment to 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2016.
- Background: PubMed 23855364McCrory P, Meeuwisse WH, Aubry M, Cantu RC, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen R, Guskiewicz KM, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport, Zurich, November 2012. J Athl Train. 2013 Jul-Aug;48(4):554-75. doi: 10.4085/1062-6050-48.4.05. No abstract available.
- Background: PubMed 19831492Gagnon I, Galli C, Friedman D, Grilli L, Iverson GL. Active rehabilitation for children who are slow to recover following sport-related concussion. Brain Inj. 2009 Nov;23(12):956-64. doi: 10.3109/02699050903373477.
- Background: PubMed 24855132Schneider KJ, Meeuwisse WH, Nettel-Aguirre A, Barlow K, Boyd L, Kang J, Emery CA. Cervicovestibular rehabilitation in sport-related concussion: a randomised controlled trial. Br J Sports Med. 2014 Sep;48(17):1294-8. doi: 10.1136/bjsports-2013-093267. Epub 2014 May 22.
- Background: PubMed 23479489Schneider KJ, Iverson GL, Emery CA, McCrory P, Herring SA, Meeuwisse WH. The effects of rest and treatment following sport-related concussion: a systematic review of the literature. Br J Sports Med. 2013 Apr;47(5):304-7. doi: 10.1136/bjsports-2013-092190.
- Background: PubMed 25735821Gagnon I, Grilli L, Friedman D, Iverson GL. A pilot study of active rehabilitation for adolescents who are slow to recover from sport-related concussion. Scand J Med Sci Sports. 2016 Mar;26(3):299-306. doi: 10.1111/sms.12441. Epub 2015 Mar 3.
- Individual participant dataSharing planned: No
Related trials for Concussion
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
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.
Kathryn Schneider principal investigator
University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing Cervicovestibular Physio (CV PT), Low-Level Aerobic Exercise (LLAE) and Combination (LLAE and CV PT) in people with Concussion, run by Sport Injury Prevention Research Centre.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 9 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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 Kathryn Schneider (403-210-8951, kjschnei@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical Clearance to return to sport (time frame: 8 weeks). 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 NCT02988323, which also lists 5 linked publications.
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 9 Dec 2016.