Effects of Physiotherapy in Individuals With Persistent Symptoms Following Concussion

Sport-related Concussion Clinical Trial

— PTConc  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01860755
• Other study ID #: SIPRC-PT-conc-01
• Status: Completed
• Phase: N/A
• First received: May 20, 2013
• Last updated: May 23, 2013
• Start date: November 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2013
• Source: Sport Injury Prevention Research Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 30 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sport-related Concussion

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.
• 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.

Locations

Country	Name	City	State
Canada	Sport Injury Prevention Research Centre	Calgary	Alberta

Sponsors (4)

Lead Sponsor	Collaborator
Sport Injury Prevention Research Centre	Alberta Centre for Child, Family & Community Research, University of British Columbia, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days to medical clearance to return to sport	Number of days to medical clearance by study physician	up to 8 weeks	No
Secondary	Change in Numeric Pain Rating Scale Score-Neck Pain	Self-reported cervical spine pain rated on a scale of 0-10	Change between Baseline and 8 weeks or time of medical clearance	No
Secondary	Change in Numeric Dizziness rating Score	Self reported dizziness on a scale of 0-10	Change between Baseline and 8 weeks or time of medical clearance	No
Secondary	Change in Numeric Pain Rating Scale Score-Headache	Self-report score for headache on a scale of 0-10	Change between Baseline and 8 weeks or at time of medical clearance	No
Secondary	Change in Activities Specific Balance Confidence Scale Score	Self report measure of confidence during 16 balance activities	Change between Baseline and 8 weeks or time of medical clearance	No
Secondary	Change in Dizziness Handicap Index Score	Self report measure evaluating perceived handicap secondary to dizziness	Change between Baseline and 8 weeks or time of medical clearance	No
Secondary	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	Change between Baseline and 8 weeks or time of medical clearance	No
Secondary	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.	Change between Baseline and 8 weeks or time of medical clearance	No
Secondary	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.	Baseline and at 8 weeks or time of medical clearance	No
Secondary	Change in modified Motion Sensitivity Test Score	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	No
Secondary	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.	Change between Baseline and 8 weeks or time of medical clearance	No
Secondary	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.	Change between Baseline and 8 weeks or time of medical clearance	No
Secondary	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.	Change between Baseline and 8 weeks or time of medical clearance	No