Sport-related ConcussionPTConcNCT01860755
Effects of Physiotherapy in Individuals With Persistent Symptoms Following Concussion
A study testing Physiotherapy in people with Sport-related Concussion, run by Sport Injury Prevention Research Centre at 1 site in Canada.
Trial summary
The purpose of this study is to determine the effects of a combined physiotherapy treatment (including vestibular rehabilitation and treatment for the cervical spine) in youth and young adults with ongoing symptoms of dizziness, neck pain and headaches following a sport-related concussion. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Sport-related Concussion
- What is being tested?
- Physiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2010to Dec 2011
- 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 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Sport-related concussion as per the Third International Consensus Guidelines
- Persistent symptoms (greater than 10 days) of dizziness, unsteadiness, neck pain and/or headaches reported on the Sport Concussion Assessment Tool 2 (SCAT2)
- Clinical examination findings suggesting vestibular and/or cervical spine involvement
Who cannot join
- Fracture, other neurological conditions, musculoskeletal injuries (other than the cervical spine) that restrict activity and medications that affect neural adaptation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physiotherapy Treatment (Including Vestibular Rehabilitation) Compared to Rest in Individuals With Persistent Symptoms of Dizziness, Neck Pain and/or Headache Following Sport-related Concussion.
The purpose of this study is to determine the effects of a combined physiotherapy treatment (including vestibular rehabilitation and treatment for the cervical spine) in youth and young adults with ongoing symptoms of dizziness, neck pain and headaches following a sport-related concussion.
- Conditions
- Sport-related Concussion
- Being tested
- Control postural education, general range of motion and strengthening in addition to the standard of care, Physiotherapy
- Keywords
- Sport-related concussion, Dizziness, Neck pain, Headaches, Physiotherapy, Treatment
- Medical subject headings
- Dizziness, Neck Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control postural education, general range of motion and strengthening in addition to the standard of careOther
Control: postural education, general range of motion and strengthening in addition to the standard of care rest followed by graded exertion. Individuals were seen once weekly for eight weeks or until time of medical clearance to return to sport.
PhysiotherapyOther
Physiotherapy: including vestibular rehabilitation and multimodal treatment for the cervical spine, once weekly with the study physiotherapist for 8 weeks or until time of medical clearance to return to sport.
| Study group | Role | What they receive |
|---|---|---|
| Physiotherapy | Experimental | Physiotherapy: including vestibular rehabilitation and multimodal treatment for the cervical spine, once weekly with the study physiotherapist for 8 weeks or until time of medical clearance to return to sport. This group also received the control intervention. Receives: Other: Control postural education, general range of motion and strengthening in addition to the standard of care; Other: Physiotherapy |
| Control | Active comparator | Control: postural education, general range of motion and strengthening in addition to the standard of care rest followed by graded exertion. Individuals were seen once weekly for eight weeks or until time of medical clearance to return to sport. Receives: Other: Control postural education, general range of motion and strengthening in addition to the standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to medical clearance to return to sport
Number of days to medical clearance by study physician
Measured: up to 8 weeks
Secondary outcomes (12)
Change in Numeric Pain Rating Scale Score-Neck Pain
Self-reported cervical spine pain rated on a scale of 0-10
Measured: Change between Baseline and 8 weeks or time of medical clearance
Change in Numeric Dizziness rating Score
Self reported dizziness on a scale of 0-10
Measured: Change between Baseline and 8 weeks or time of medical clearance
Change in Numeric Pain Rating Scale Score-Headache
Self-report score for headache on a scale of 0-10
Measured: Change between Baseline and 8 weeks or at time of medical clearance
Change in Activities Specific Balance Confidence Scale Score
Self report measure of confidence during 16 balance activities
Measured: Change between Baseline and 8 weeks or time of medical clearance
Change in Dizziness Handicap Index Score
Self report measure evaluating perceived handicap secondary to dizziness
Measured: Change between Baseline and 8 weeks or time of medical clearance
Change in Sport Concussion Assessment Tool 2 (SCAT2)
Multifaceted tool used in the assessment of concussion and includes domains of symptom report, cognitive function, balance and coordination
Measured: Change between Baseline and 8 weeks or time of medical clearance
Change in Dynamic Visual Acuity
Assessed clinically using an eye chart and a metronome set at 2 Hz. Static visual acuity is measured 13 feet from the target. The subjects head is rotated at 2 Hz and visual acuity is measured dynamically. The difference between static and dynamic visual acuity is calculated.
Measured: Change between Baseline and 8 weeks or time of medical clearance
Head Thrust Test
Clinical test performed in sitting with head flexed and high velocity low amplitude motion into 5-15 degrees rotation is performed while the subject is asked to maintain focus with the examiner's nose.
Measured: Baseline and at 8 weeks or time of medical clearance
Change in modified Motion Sensitivity Test Score
Patient report of intensity and duration of dizziness with eight head or body motions
Measured: Change between Baseline and 8 weeks or time of medical clearance
Change in Functional Gait Assessment Score
Dynamic Balance Measure that includes 10 different movements and the ability to complete each activity is rated by the examiner.
Measured: Change between Baseline and 8 weeks or time of medical clearance
Change in Cervical Flexor Endurance
Test to evaluate the time (seconds) that an individual can maintain the head in a position of craniovertebral flexion and two finger widths above a pillow in crook lying.
Measured: Change between Baseline and 8 weeks or time of medical clearance
Change in Joint Position Error
Clinical test using a laser pointer affixed to a head piece on top of the head that is projected onto a bull's eye target. Subject rotates head to left, right (rotation) or up (extension) to the maximum comfortable range and relocates to the perceived point of neutral head position with eyes closed. A measures from the centre of the bull's eye is recorded. A mean of three trials is recorded for each direction.
Measured: Change between Baseline and 8 weeks or time of medical clearance
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startNov 2010
- Primary completionDec 2011
- Study completionDec 2011
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.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sport Injury Prevention Research Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Centre for Child, Family & Community Research, University of Calgary, University of British Columbia
- Responsible party
- Sponsor
- Investigators
- Willem H Meeuwisse, MD, PhD, Principal investigator, Sport Injury Prevention Research Centre, University of CalgaryCarolyn A Emery, PT, PhD, Principal investigator, Sport Injury Prevention Research Centre, University of CalgaryKathryn J Schneider, PT, PhD, Study director, Sport Injury Prevention Research Centre, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860755
- Sponsor's protocol ID
- SIPRC-PT-conc-01
- Acronym
- PTConc
- Status last verified
- May 2013
- First submitted
- 20 May 2013
- Last updated
- 24 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Schneider 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 24855132
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiotherapy Treatment (Including Vestibular Rehabilitation) Compared to Rest in Individuals With Persistent Symptoms of Dizziness, Neck Pain and/or Headache Following Sport-related Concussion.
- ClinicalTrials.gov ID
- NCT01860755
- Acronym / sponsor ID
- PTConc / SIPRC-PT-conc-01
- Conditions
- Sport-related Concussion
- Keywords
- Sport-related concussion, Dizziness, Neck pain, Headaches, Physiotherapy, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sport Injury Prevention Research CentreUniversity, hospital or other
- Collaborators
- Alberta Centre for Child, Family & Community Research, University of Calgary, University of British Columbia
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 23 May 2013 (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 study is to determine the effects of a combined physiotherapy treatment (including vestibular rehabilitation and treatment for the cervical spine) in youth and young adults with ongoing symptoms of dizziness, neck pain and headaches following a sport-related concussion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiotherapy | Experimental | Other: Control postural education, general range of motion and strengthening in addition to the standard of care, Other: PhysiotherapyPhysiotherapy: including vestibular rehabilitation and multimodal treatment for the cervical spine, once weekly with the study physiotherapist for 8 weeks or until time of medical clearance to return to sport. This group also received the control intervention. |
| Control | Active comparator | Other: Control postural education, general range of motion and strengthening in addition to the standard of careControl: postural education, general range of motion and strengthening in addition to the standard of care rest followed by graded exertion. Individuals were seen once weekly for eight weeks or until time of medical clearance to return to sport. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of Sport-related concussion as per the Third International Consensus Guidelines
- Persistent symptoms (greater than 10 days) of dizziness, unsteadiness, neck pain and/or headaches reported on the Sport Concussion Assessment Tool 2 (SCAT2)
- Clinical examination findings suggesting vestibular and/or cervical spine involvement
Key exclusion criteria (1 listed)
- Fracture, other neurological conditions, musculoskeletal injuries (other than the cervical spine) that restrict activity and medications that affect neural adaptation
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 |
|---|---|---|
| Control postural education, general range of motion and strengthening in addition to the standard of careControl: postural education, general range of motion and strengthening in addition to the standard of care rest followed by graded exertion. Individuals were seen once weekly for eight weeks or until time of medical clearance to return to sport. | Other | Control, Physiotherapy |
| PhysiotherapyPhysiotherapy: including vestibular rehabilitation and multimodal treatment for the cervical spine, once weekly with the study physiotherapist for 8 weeks or until time of medical clearance to return to sport. | Other | Physiotherapy |
Primary outcome
Days to medical clearance to return to sport
Time frame: up to 8 weeks
Number of days to medical clearance by study physician
12 secondary outcomes
Change in Numeric Pain Rating Scale Score-Neck Pain
Time frame: Change between Baseline and 8 weeks or time of medical clearance
Change in Numeric Dizziness rating Score
Time frame: Change between Baseline and 8 weeks or time of medical clearance
Change in Numeric Pain Rating Scale Score-Headache
Time frame: Change between Baseline and 8 weeks or at time of medical clearance
Change in Activities Specific Balance Confidence Scale Score
Time frame: Change between Baseline and 8 weeks or time of medical clearance
Change in Dizziness Handicap Index Score
Time frame: Change between Baseline and 8 weeks or time of medical clearance
Change in Sport Concussion Assessment Tool 2 (SCAT2)
Time frame: Change between Baseline and 8 weeks or time of medical clearance
Change in Dynamic Visual Acuity
Time frame: Change between Baseline and 8 weeks or time of medical clearance
Head Thrust Test
Time frame: Baseline and at 8 weeks or time of medical clearance
Change in modified Motion Sensitivity Test Score
Time frame: Change between Baseline and 8 weeks or time of medical clearance
Change in Functional Gait Assessment Score
Time frame: Change between Baseline and 8 weeks or time of medical clearance
Change in Cervical Flexor Endurance
Time frame: Change between Baseline and 8 weeks or time of medical clearance
Change in Joint Position Error
Time frame: Change between Baseline and 8 weeks or time of medical clearance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2013.
- Derived from this study: 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.
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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.
Willem H Meeuwisse, MD, PhD principal investigator
Sport Injury Prevention Research Centre, University of Calgary
Carolyn A Emery, PT, PhD principal investigator
Sport Injury Prevention Research Centre, University of Calgary
Kathryn J Schneider, PT, PhD study director
Sport Injury Prevention Research Centre, University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiotherapy in people with Sport-related Concussion, run by Sport Injury Prevention Research Centre 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 24 May 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Days to medical clearance to return to sport (time frame: up to 8 weeks). 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 NCT01860755, 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 24 May 2013.