Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01860755
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : May 24, 2013
Sponsor:
Collaborators:
Alberta Centre for Child, Family & Community Research
University of Calgary
University of British Columbia
Information provided by (Responsible Party):
Sport Injury Prevention Research Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Sport-related Concussion Other: Control postural education, general range of motion and strengthening in addition to the standard of care Other: Physiotherapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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.
Study Start Date : November 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


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.
Other: Control postural education, general range of motion and strengthening in addition to the standard of care
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.

Other: 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.

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.
Other: Control postural education, general range of motion and strengthening in addition to the standard of care
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.




Primary Outcome Measures :
  1. Days to medical clearance to return to sport [ Time Frame: up to 8 weeks ]
    Number of days to medical clearance by study physician


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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.

  12. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01860755


Locations
Layout table for location information
Canada, Alberta
Sport Injury Prevention Research Centre
Calgary, Alberta, Canada, T2N 1N4
Sponsors and Collaborators
Sport Injury Prevention Research Centre
Alberta Centre for Child, Family & Community Research
University of Calgary
University of British Columbia
Investigators
Layout table for investigator information
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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Sport Injury Prevention Research Centre
ClinicalTrials.gov Identifier: NCT01860755    
Other Study ID Numbers: SIPRC-PT-conc-01
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: May 24, 2013
Last Verified: May 2013
Keywords provided by Sport Injury Prevention Research Centre:
Sport-related concussion
Dizziness
Neck pain
Headaches
Physiotherapy
Treatment
Additional relevant MeSH terms:
Layout table for MeSH terms
Dizziness
Neurologic Manifestations
Sensation Disorders