Study Stopped
feasibility; challenges with recruitment
Trial Study of an Exercise Program for Youth With Persistent Symptoms After Concussion
Comparing Active Rehabilitation to a Comprehensive Education Intervention for Youth With Persistent Post-concussion Symptoms Following Concussion.
1 other identifier
interventional
1
1 country
1
Brief Summary
The purpose of this randomized control trial study is to determine if an active rehabilitation (low intensity exercise program) in combination with a comprehensive education intervention (standard care) is more effective than the comprehensive education intervention alone in reducing post-concussion symptoms and improving participation in daily activities in youth who have persistent post-concussion symptoms.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2014
CompletedFirst Posted
Study publicly available on registry
October 6, 2014
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMarch 25, 2022
March 1, 2022
1.9 years
October 2, 2014
March 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Post-Concussion Symptoms
The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.
Week 0 (Baseline)
Post Concussion Symptoms
The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.
Week 2
Post Concussion Symptoms
The Post-Concussion Symptom Inventory will be used. This is a self report questionnaire that asks about subjectively experienced symptoms (presence and severity) such as headache, dizziness, memory troubles, after concussion.
Week 6 (upon completion of intervention)
Secondary Outcomes (24)
Mood
Week 0 (Baseline)
Mood
Week 6 (upon completion of the intervention)
Behavior
Week 0 (Baseline)
Behavior
Week 6 (upon completion of the intervention)
Energy Level
Week 0 (Baseline)
- +19 more secondary outcomes
Study Arms (2)
Active Rehabilitation
EXPERIMENTALActive Rehabilitation Intervention and Comprehensive Education Intervention (Standard Care)
Comprehensive Education Intervention
ACTIVE COMPARATORComprehensive Education Intervention (Standard Care) only
Interventions
The active rehabilitation intervention is a 6-week graded rehabilitation program, consisting of four components that are anchored in neuroscience evidence.The four components include: 1) aerobic exercise 2) coordination exercise 3) visualization 4) home program.
An initial education session will be provided by an occupational therapist related to general concussion information and outcomes, as well as strategies for symptom management following concussion.
Eligibility Criteria
You may qualify if:
- confirmed diagnosis of concussion
- have at least one post-concussion symptom (as measured by the Post Concussion Symptom Inventory)
- are at least 4 weeks post injury
- between the ages of 10 and 18 years
- ability to speak English
- ability to demonstrate capacity to consent to study
You may not qualify if:
- prior moderate or severe brain injury
- neck pain/dysfunction or oculormotor/vestibular dysfunction, developmental delays, mental health disorders or chronic pain conditions that prevent participation in active rehabilitation, assessment of gait and balance, or participation in cognitive testing
- participating in any other physical rehabilitation interventions for post-concussion symptoms (e.g., physiotherapy, massage therapy, chiropractic) at time of enrollment and throughout the duration of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8, Canada
Related Publications (1)
Reed N, Greenspoon D, Iverson GL, DeMatteo C, Fait P, Gauvin-Lepage J, Hunt A, Gagnon IJ. Management of persistent postconcussion symptoms in youth: a randomised control trial protocol. BMJ Open. 2015 Jul 31;5(7):e008468. doi: 10.1136/bmjopen-2015-008468.
PMID: 26231756DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nick Reed, PhD, MSc(OT)
Holland Bloorview Kids Rehabilitation Hospital/ Bloorview Research Institute
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
October 2, 2014
First Posted
October 6, 2014
Study Start
January 1, 2016
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
March 25, 2022
Record last verified: 2022-03