Back to resultsSafety and Feasibility of Early Active Rehabilitation in Children After Concussion
Primary Purpose
Post-Concussion Symptoms, Concussion
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Active Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Post-Concussion Symptoms
Eligibility 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
Sites / Locations
- Montreal Children's Hospital, MUHC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early Rehab
late rehab
Arm Description
Children will begin active rehabilitation 2 weeks post-injury
Children will begin active rehabilitation 4 weeks post-injury
Outcomes
Primary Outcome Measures
Post-concussion symptoms
Post-Concussion Symptoms Inventory scale total score
Secondary Outcome Measures
Full Information
NCT ID
NCT03103529
First Posted
April 1, 2017
Last Updated
May 1, 2017
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
1. Study Identification
Unique Protocol Identification Number
NCT03103529
Brief Title
Safety and Feasibility of Early Active Rehabilitation in Children After Concussion
Official Title
Safety and Feasibility of Early Active Rehabilitation in Children After Concussion
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Concussion Symptoms, Concussion
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early Rehab
Arm Type
Experimental
Arm Description
Children will begin active rehabilitation 2 weeks post-injury
Arm Title
late rehab
Arm Type
Active Comparator
Arm Description
Children will begin active rehabilitation 4 weeks post-injury
Intervention Type
Other
Intervention Name(s)
Active Rehabilitation
Primary Outcome Measure Information:
Title
Post-concussion symptoms
Description
Post-Concussion Symptoms Inventory scale total score
Time Frame
6 weeks post-injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Montreal Children's Hospital, MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A3J1
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Safety and Feasibility of Early Active Rehabilitation in Children After Concussion
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