Effects of Physiotherapy in Individuals With Persistent Symptoms Following Concussion (PTConc)

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

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
      • Calgary, Alberta, Canada, T2N 1N4
        • Sport Injury Prevention Research Centre

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
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.
Change between Baseline and 8 weeks or time of medical clearance

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

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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