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Safety and Feasibility of Early Active Rehabilitation in Children After Concussion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103529
Recruitment Status : Unknown
Verified May 2017 by Isabelle Gagnon, McGill University Health Centre/Research Institute of the McGill University Health Centre.
Recruitment status was:  Active, not recruiting
First Posted : April 6, 2017
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
Isabelle Gagnon, McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary:
It has been suggested that activity immediately following concussion is detrimental to recovery and may lead to long term impairments. The animal model has shown that exercise too soon can lead to neurometabolic energy imbalances within the brain. However, there is also evidence to suggest that prolonged inactivity has negative consequences that may contribute to prolongation of symptoms. Determining the ideal timeframe in which to initiate an active rehabilitation protocol for patients who are slow to recovery is an important factor in concussion management.

Condition or disease Intervention/treatment Phase
Post-Concussion Symptoms Concussion Other: Active Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of Early Active Rehabilitation in Children After Concussion
Actual Study Start Date : May 2016
Actual Primary Completion Date : January 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Arm Intervention/treatment
Experimental: Early Rehab
Children will begin active rehabilitation 2 weeks post-injury
Other: Active Rehabilitation
Active Comparator: late rehab
Children will begin active rehabilitation 4 weeks post-injury
Other: Active Rehabilitation



Primary Outcome Measures :
  1. Post-concussion symptoms [ Time Frame: 6 weeks post-injury ]
    Post-Concussion Symptoms Inventory scale total score



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • referred to the mTBI clinic of the MCH for atypical recovery (defined as the presence of symptoms with little improvement at 10 days post-injury preventing them from entering standard return to activities protocols)

Exclusion Criteria:

  • co-morbidity preventing children from participating in intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103529


Locations
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Canada, Quebec
Montreal Children's Hospital, MUHC
Montreal, Quebec, Canada, H4A3J1
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
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Responsible Party: Isabelle Gagnon, Clinician Scientist/Associate Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier: NCT03103529    
Other Study ID Numbers: 13-142-PED
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Additional relevant MeSH terms:
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Post-Concussion Syndrome
Brain Concussion
Head Injuries, Closed
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Wounds, Nonpenetrating