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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sport Injury Prevention Research Centre

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of British Columbia
University of Calgary
Alberta Centre for Child, Family & Community Research

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 20, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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