NCT02031068

Brief Summary

To test the safety and feasibility of a new treatment for adolescents who are slow to recover from a sport-related concussion, the investigators are conducting a randomised controlled trial comparing treatment as usual with an active rehabilitation program that involves sub-symptom threshold cardiac exertion, sport-specific coordination activities, and positive visualisation techniques.

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
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

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

December 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

2.2 years

First QC Date

December 10, 2013

Last Update Submit

April 7, 2015

Conditions

Sport-related ConcussionConcussionMild Traumatic Brain Injury (MTBI)

Keywords

active rehabilitationexerciseconcussion

Outcome Measures

Primary Outcomes (2)

  • Symptom Report

    The Post-Concussion Scale consists of 22 subjectively-experienced symptoms (e.g., headache, dizziness, concentration problems, and fogginess). A total score is derived from this 22-item scale. Athletes report symptoms based on the severity of each symptom that day, allowing tracking of symptoms over very short intervals

    Baseline

  • Symptom Report

    At 8 weeks (end-of-treatment)

Secondary Outcomes (10)

  • Mood

    Baseline

  • Energy level

    Baseline

  • Balance Testing

    Baseline

  • Neurocognitive Testing

    Baseline

  • Return to School and Sport

    Baseline

  • +5 more secondary outcomes

Study Arms (2)

Treatment-as-usual (TAU)

ACTIVE COMPARATOR

The TAU program will be implemented after the initial assessment. It will consist of 2 components: 1. An initial education session by an occupational therapist, relating to outcome from concussion and managing symptoms 2. A school consultation to provide teacher education, recommend accommodations, and facilitate return to school

Behavioral: Treatment-as-usual (TAU)

Behavioral:Active Rehabilitation Program

EXPERIMENTAL

The active rehabilitation program will be implemented for a maximum of 6-8 weeks. Each participant will be followed by regular weekly telephone calls or personal follow-up relating to outcome from concussion and managing symptoms. The participant will receive TAU (above) in addition to the 4 components listed below: 1. Sub-maximal aerobic training for up to 15 minutes 2. Light coordination and sport-specific exercises for up to 10 minutes 3. Visualization and imagery techniques 4. Home program. A physiotherapist will supervise the rehabilitation.

Behavioral: Active Rehabilitation Program

Interventions

Active Rehabilitation ProgramBEHAVIORAL

The active rehabilitation program will be implemented for a maximum of 6-8 weeks. Each participant will be followed by regular weekly telephone calls or personal follow-up relating to outcome from concussion and managing symptoms. The participant will receive TAU (above) in addition to the 4 components listed below: 1. Sub-maximal aerobic training for up to 15 minutes 2. Light coordination and sport-specific exercises for up to 10 minutes 3. Visualization and imagery techniques 4. Home program A physiotherapist will supervise the rehabilitation.

Behavioral:Active Rehabilitation Program
Treatment-as-usual (TAU)BEHAVIORAL

The TAU program will be implemented after the initial assessment. It will consist of 2 components: An initial education session by an occupational therapist, relating to outcome from concussion and managing symptoms A school consultation to provide teacher education, recommend accommodations, and facilitate return to school

Treatment-as-usual (TAU)

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Adolescents referred to G. F. Strong Rehabilitation Centre (GFS) for atypical recovery preventing them from entering standard return to activities protocols will be recruited on a voluntary basis to participate in this study. Eligibility criteria for study entry are as follows: 1. sustained an injury in sports, 2. are 4 weeks post injury, 3. report 2+ persistent post-concussion symptoms with no significant improvement over the past week, 4. are between the ages of 14 and 18, 5. have no developmental, congenital, or cognitive diagnoses, 6. have no active mental health disorders, 7. are able to attend at GFS, 8. speak English as their dominant language, 9. have no prior moderate or severe TBI, 10. have no concussion in the 6 months before the present injury, and 11. medical clearance by the study physician.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

GF Strong Rehabilitation Centre

Vancouver, British Columbia, V5Z 2G9, Canada

RECRUITING

Related Publications (1)

  • Chan C, Iverson GL, Purtzki J, Wong K, Kwan V, Gagnon I, Silverberg ND. Safety of Active Rehabilitation for Persistent Symptoms After Pediatric Sport-Related Concussion: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):242-249. doi: 10.1016/j.apmr.2017.09.108. Epub 2017 Oct 5.

    PMID: 28989074DERIVED

MeSH Terms

Conditions

Brain ConcussionMotor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

  • Catherine Chan, Physiotherapy

    GF Strong Rehab Centre - Vancouver Coastal Health Research Institute

    PRINCIPAL INVESTIGATOR

  • Grant Iverson, Ph.D

    University of British Columbia, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Chan, MPT

CONTACT

(604) 734-1313Catherine.chan2@vch.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2013

First Posted

January 9, 2014

Study Start

December 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

CA(1)