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Clinical Trials/NCT02031068
NCT02031068UnknownNot Applicable

Active Rehabilitation for Slow to Recover Adolescents Following Sport-Related Concussion: A Randomized Control Trial

University of British Columbia2 sites in 1 country30 target enrollmentStarted: December 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
30
Locations
2
Primary Endpoint
Symptom Report

Study Overview

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.

Detailed Description

Most adolescents recover within the first month following a sport-related concussion. However, some do not. Little is known about how to best facilitate recovery when symptoms do not resolve spontaneously and swiftly. Although active rehabilitation has been recently suggested as a promising means of promoting recovery, current literature does not provide adequate evidence for safe adaptation into clinical practice.

Objective: The purpose of this project is to evaluate an active rehabilitation protocol for adolescents who are slow to recover following sport-related concussion. Primary aims: to confirm the tolerability and safety of the active rehabilitation protocol as compared to treatment as usual controls. Secondary aims: 1) to document the impact of active rehabilitation on post-concussion symptoms and return to activity; 2) to explore the intervention effects on quality of life, mood, energy level, balance, cognitive functioning, and return to pre-injury activities.

Study design: A parallel group open label randomized comparison trial of 30 adolescents who are slow to recover following sport-related concussion. After initial screening and assessment, both groups will receive treatment as usual. Participants in the experimental group will also participate in sub-symptom threshold exercise, sport-specific coordination practice, and positive visualisation daily.

Outcome measures: The investigators will monitor for adverse events and assess post-concussion symptoms throughout the study as a primary marker of recovery. The investigators will also report secondary outcomes such as quality of life, mood, energy level, balance and cognitive functioning. Finally the investigators will record rates of return to school (full time, part time) and rates of return to sport (regular pre-injury vs. modified level). As a result, clinicians will be able to follow a new rehabilitation protocol in a safe and meaningful way. Lastly, research findings will be disseminated in the form of a publication, at conferences, and via in-services.

Hypotheses:

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
14 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Symptom Report

Time Frame: At 8 weeks (end-of-treatment)

Secondary Outcomes

  • Return to School and Sport(At 8 weeks (end-of-treatment))
  • Mood(At 8 weeks (end-of-treatment))
  • Energy level(At 8 weeks (end-of-treatment))
  • Neurocognitive Testing(At 8 weeks (end-of-treatment))
  • Balance Testing(At 8 weeks (end-of-treatment))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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