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Completed

NCT Number: NCT01860755

Effects of Physiotherapy in Individuals With Persistent Symptoms Following 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.

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Key information

Conditions

Sport-related Concussion Dizziness Headache Neck Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sport Injury Prevention Research Centre

Calgary, Alberta, T2N 1N4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Other

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sport Injury Prevention Research Centre

Other

Collaborators

  • Alberta Centre for Child, Family & Community Research
  • University of British Columbia
  • University of Calgary

Registry information

Official study 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.

Acronym: PTConc

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 23, 2013
Registry last updated
May 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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