search
Back to results

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

Primary Purpose

Sport-related Concussion

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Control postural education, general range of motion and strengthening in addition to the standard of care
Physiotherapy
Sponsored by
Sport Injury Prevention Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sport-related Concussion focused on measuring Sport-related concussion, Dizziness, Neck pain, Headaches, Physiotherapy, Treatment

Eligibility Criteria

12 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sport Injury Prevention Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Physiotherapy

Control

Arm Description

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.

Outcomes

Primary Outcome Measures

Days to medical clearance to return to sport
Number of days to medical clearance by study physician

Secondary Outcome Measures

Change in Numeric Pain Rating Scale Score-Neck Pain
Self-reported cervical spine pain rated on a scale of 0-10
Change in Numeric Dizziness rating Score
Self reported dizziness on a scale of 0-10
Change in Numeric Pain Rating Scale Score-Headache
Self-report score for headache on a scale of 0-10
Change in Activities Specific Balance Confidence Scale Score
Self report measure of confidence during 16 balance activities
Change in Dizziness Handicap Index Score
Self report measure evaluating perceived handicap secondary to dizziness
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 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.
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.
Change in modified Motion Sensitivity Test Score
Patient report of intensity and duration of dizziness with eight head or body motions
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 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 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.

Full Information

First Posted
May 20, 2013
Last Updated
May 23, 2013
Sponsor
Sport Injury Prevention Research Centre
Collaborators
Alberta Centre for Child, Family & Community Research, University of Calgary, University of British Columbia
search

1. Study Identification

Unique Protocol Identification Number
NCT01860755
Brief Title
Effects of Physiotherapy in Individuals With Persistent Symptoms Following Concussion
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sport Injury Prevention Research Centre
Collaborators
Alberta Centre for Child, Family & Community Research, University of Calgary, University of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sport-related Concussion
Keywords
Sport-related concussion, Dizziness, Neck pain, Headaches, Physiotherapy, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physiotherapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Control postural education, general range of motion and strengthening in addition to the standard of care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Physiotherapy
Intervention Description
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 Outcome Measure Information:
Title
Days to medical clearance to return to sport
Description
Number of days to medical clearance by study physician
Time Frame
up to 8 weeks
Secondary Outcome Measure Information:
Title
Change in Numeric Pain Rating Scale Score-Neck Pain
Description
Self-reported cervical spine pain rated on a scale of 0-10
Time Frame
Change between Baseline and 8 weeks or time of medical clearance
Title
Change in Numeric Dizziness rating Score
Description
Self reported dizziness on a scale of 0-10
Time Frame
Change between Baseline and 8 weeks or time of medical clearance
Title
Change in Numeric Pain Rating Scale Score-Headache
Description
Self-report score for headache on a scale of 0-10
Time Frame
Change between Baseline and 8 weeks or at time of medical clearance
Title
Change in Activities Specific Balance Confidence Scale Score
Description
Self report measure of confidence during 16 balance activities
Time Frame
Change between Baseline and 8 weeks or time of medical clearance
Title
Change in Dizziness Handicap Index Score
Description
Self report measure evaluating perceived handicap secondary to dizziness
Time Frame
Change between Baseline and 8 weeks or time of medical clearance
Title
Change in Sport Concussion Assessment Tool 2 (SCAT2)
Description
Multifaceted tool used in the assessment of concussion and includes domains of symptom report, cognitive function, balance and coordination
Time Frame
Change between Baseline and 8 weeks or time of medical clearance
Title
Change in Dynamic Visual Acuity
Description
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.
Time Frame
Change between Baseline and 8 weeks or time of medical clearance
Title
Head Thrust Test
Description
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.
Time Frame
Baseline and at 8 weeks or time of medical clearance
Title
Change in modified Motion Sensitivity Test Score
Description
Patient report of intensity and duration of dizziness with eight head or body motions
Time Frame
Change between Baseline and 8 weeks or time of medical clearance
Title
Change in Functional Gait Assessment Score
Description
Dynamic Balance Measure that includes 10 different movements and the ability to complete each activity is rated by the examiner.
Time Frame
Change between Baseline and 8 weeks or time of medical clearance
Title
Change in Cervical Flexor Endurance
Description
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.
Time Frame
Change between Baseline and 8 weeks or time of medical clearance
Title
Change in Joint Position Error
Description
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.
Time Frame
Change between Baseline and 8 weeks or time of medical clearance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Willem H Meeuwisse, MD, PhD
Organizational Affiliation
Sport Injury Prevention Research Centre, University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carolyn A Emery, PT, PhD
Organizational Affiliation
Sport Injury Prevention Research Centre, University of Calgary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathryn J Schneider, PT, PhD
Organizational Affiliation
Sport Injury Prevention Research Centre, University of Calgary
Official's Role
Study Director
Facility Information:
Facility Name
Sport Injury Prevention Research Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 1N4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24855132
Citation
Schneider KJ, Meeuwisse WH, Nettel-Aguirre A, Barlow K, Boyd L, Kang J, Emery CA. Cervicovestibular rehabilitation in sport-related concussion: a randomised controlled trial. Br J Sports Med. 2014 Sep;48(17):1294-8. doi: 10.1136/bjsports-2013-093267. Epub 2014 May 22.
Results Reference
derived

Learn more about this trial

Effects of Physiotherapy in Individuals With Persistent Symptoms Following Concussion

We'll reach out to this number within 24 hrs