NCT01860755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2013

Completed
Last Updated

May 24, 2013

Status Verified

May 1, 2013

Enrollment Period

1.1 years

First QC Date

May 20, 2013

Last Update Submit

May 23, 2013

Conditions

Keywords

Sport-related concussionDizzinessNeck painHeadachesPhysiotherapyTreatment

Outcome Measures

Primary Outcomes (1)

  • Days to medical clearance to return to sport

    Number of days to medical clearance by study physician

    up to 8 weeks

Secondary Outcomes (12)

  • Change in Numeric Pain Rating Scale Score-Neck Pain

    Change between Baseline and 8 weeks or time of medical clearance

  • Change in Numeric Dizziness rating Score

    Change between Baseline and 8 weeks or time of medical clearance

  • Change in Numeric Pain Rating Scale Score-Headache

    Change between Baseline and 8 weeks or at time of medical clearance

  • Change in Activities Specific Balance Confidence Scale Score

    Change between Baseline and 8 weeks or time of medical clearance

  • Change in Dizziness Handicap Index Score

    Change between Baseline and 8 weeks or time of medical clearance

  • +7 more secondary outcomes

Study Arms (2)

Physiotherapy

EXPERIMENTAL

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 careOther: Physiotherapy

Control

ACTIVE COMPARATOR

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

Interventions

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.

ControlPhysiotherapy

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.

Physiotherapy

Eligibility Criteria

Age12 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Fracture, other neurological conditions, musculoskeletal injuries (other than the cervical spine) that restrict activity and medications that affect neural adaptation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport Injury Prevention Research Centre

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DizzinessNeck PainHeadache

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
  • Kathryn J Schneider, PT, PhD

    Sport Injury Prevention Research Centre, University of Calgary

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 23, 2013

Study Start

November 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 24, 2013

Record last verified: 2013-05

Locations