NCT03360786

Brief Summary

  1. 1.Background and Rationale:
  2. 2.Research Question and Objectives
  3. 3.Methods

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
unknown

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

October 4, 2017

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 24, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 4, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2018

Completed
Last Updated

December 4, 2017

Status Verified

November 1, 2017

Enrollment Period

11 months

First QC Date

October 24, 2017

Last Update Submit

November 27, 2017

Conditions

Keywords

sport concussioncervical spineyouth

Outcome Measures

Primary Outcomes (2)

  • Efficacy of Concussion prevention protocol

    A primary outcome of interest is diagnosis of concussion. This will be determined by the study sport medicine physician in accordance with current standards of care and as per the 5th International Consensus on Concussion in Sport Statement. Medical clearance to return to sport will be determined by the study sport medicine physician according to the 5th Consensus on Concussion in Sport Statement.

    6 months (length of hockey season)

  • Number of participants able to complete protocol.

    Number of participants completing each intervention will be calculated

    6 months (length of hockey season)

Secondary Outcomes (15)

  • Pediatric Quality of Life Scale (PedsQL)

    Time 0, 4 weeks, end of hockey season (approximately 6 months)

  • Numeric Pain Rating Scale for Neck pain

    Time 0, 4 weeks, end of hockey season (approximately 6 months)

  • Numeric Pain Rating Scale for Headache

    Time 0, 4 weeks, end of hockey season (approximately 6 months)

  • Numeric Dizziness Rating Scale

    Time 0, 4 weeks, end of hockey season (approximately 6 months)

  • Sport Concussion Assessment Tool 5 (SCAT5)

    Time 0, 4 weeks, end of hockey season (approximately 6 months)

  • +10 more secondary outcomes

Study Arms (2)

Specific Protocol

EXPERIMENTAL

The intervention group will work with the study physiotherapist and perform a 10-20 minute progressive exercises twice per week. The intervention will include a series of exercises including dynamic balance, adaptation, cervical spine strength, cervical spine neuromotor control and divided attention exercises. Exercises will begin at a lower level and progress to increasingly difficult levels of each exercise type over the course of the intervention. Concussion education and injury identification will also be completed.

Other: Specific intervention

Control Protocol

ACTIVE COMPARATOR

The control group will continue with their standard warm up and practice schedule but have the addition of contact time with the study physiotherapist for education regarding concussion education and injury identification.

Other: Control intervention

Interventions

Series of progressive exercises targeted at balance, adaptation, dividing attention, head on neck control, visual + education on concussion identification and concussion education

Specific Protocol

Education on concussion and concussion identification in addition to typical cardiovascular warmups

Control Protocol

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • Inability to participate in physical activity for a reason other than sport related concussion.
  • Inability to communicate in English language.
  • Neurodevelopmental delays expected to affect ability to adapt with treatment.
  • Orthopaedic or other injury affecting ability to participate.
  • Medication known to affect neural adaptation as they may alter the response to treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary Sport

Calgary, Alberta, T2N 1N4, Canada

RECRUITING

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

Brain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds and InjuriesWounds, Nonpenetrating

Study Officials

  • Kathryn J Schneider, PT, PhD

    Sport Injury Prevention Research Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn J Schneider, PT, PhD

CONTACT

Carolyn A Emery, PT, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
An assessor who is blinded to group allocation will perform the pre and post assessment measures.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2017

First Posted

December 4, 2017

Study Start

October 4, 2017

Primary Completion

August 31, 2018

Study Completion

December 29, 2018

Last Updated

December 4, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

At this time there is no plan to share individual participant data with others outside of the research team.

Locations