- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01860755
Effects of Physiotherapy in Individuals With Persistent Symptoms Following Concussion (PTConc)
May 23, 2013 updated by: Sport Injury Prevention Research Centre
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alberta
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Calgary, Alberta, Canada, T2N 1N4
- Sport Injury Prevention Research Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 30 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Fracture, other neurological conditions, musculoskeletal injuries (other than the cervical spine) that restrict activity and medications that affect neural adaptation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Physiotherapy
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.
|
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.
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.
|
Active Comparator: Control
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days to medical clearance to return to sport
Time Frame: up to 8 weeks
|
Number of days to medical clearance by study physician
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up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Numeric Pain Rating Scale Score-Neck Pain
Time Frame: Change between Baseline and 8 weeks or time of medical clearance
|
Self-reported cervical spine pain rated on a scale of 0-10
|
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
|
Self reported dizziness on a scale of 0-10
|
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
|
Self-report score for headache on a scale of 0-10
|
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
|
Self report measure of confidence during 16 balance activities
|
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
|
Self report measure evaluating perceived handicap secondary to dizziness
|
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
|
Multifaceted tool used in the assessment of concussion and includes domains of symptom report, cognitive function, balance and coordination
|
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
|
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.
|
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
|
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.
|
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
|
Patient report of intensity and duration of dizziness with eight head or body motions
|
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
|
Dynamic Balance Measure that includes 10 different movements and the ability to complete each activity is rated by the examiner.
|
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
|
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.
|
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
|
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.
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Change between Baseline and 8 weeks or time of medical clearance
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Willem H Meeuwisse, MD, PhD, Sport Injury Prevention Research Centre, University of Calgary
- Principal Investigator: Carolyn A Emery, PT, PhD, Sport Injury Prevention Research Centre, University of Calgary
- Study Director: Kathryn J Schneider, PT, PhD, Sport Injury Prevention Research Centre, University of Calgary
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2010
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
May 20, 2013
First Submitted That Met QC Criteria
May 22, 2013
First Posted (Estimate)
May 23, 2013
Study Record Updates
Last Update Posted (Estimate)
May 24, 2013
Last Update Submitted That Met QC Criteria
May 23, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIPRC-PT-conc-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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