Exercise for Adolescents Following Sport-Related Concussion: A Randomized Control Trial

Concussion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02031068
• Other study ID #: H12-01780
• Status: Recruiting
• Phase: N/A
• First received: December 10, 2013
• Last updated: April 7, 2015
• Start date: December 2013
• Est. completion date: February 2016

Study information

• Verified date: April 2015
• Source: University of British Columbia
• Contact: Catherine Chan, MPT
• Phone: (604) 734-1313
• Email: Catherine.chan2[@]vch.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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:

1a. The drop-out rate will be comparable in the groups receiving treatment-as-usual (TAU) only versus TAU plus active rehabilitation.

1b. Adverse events occurring outside of the clinic will be comparable in the groups receiving TAU only versus TAU plus active rehabilitation.

1c. For the group receiving active rehabilitation, symptom exacerbations in the in-clinic exercise sessions will resolve within 30 minutes.

2. Participants receiving active rehabilitation will report greater improvement of post-concussion symptoms (primary outcome) at follow-up.

3. Participants receiving active rehabilitation will report higher quality of life, fewer depressive symptoms, and higher energy levels; demonstrate better balance and neuropsychological performance at follow-up; and return to their pre-injury activities at higher rates.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Concussion
• Mild Traumatic Brain Injury (MTBI)
• Sport-related Concussion

Intervention

Behavioral:
• Active Rehabilitation Program
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: Sub-maximal aerobic training for up to 15 minutes Light coordination and sport-specific exercises for up to 10 minutes Visualization and imagery techniques Home program A physiotherapist will supervise the rehabilitation.
• Treatment-as-usual (TAU)
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

Locations

Country	Name	City	State
Canada	GF Strong Rehabilitation Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Symptom Report		At 8 weeks (end-of-treatment)	No
Secondary	Mood	The Beck Depression Inventory for Youth-Second Edition is a 20-item depression screening test designed for children and adolescents.	Baseline	No
Secondary	Energy level	Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale will be used to monitor fatigue in the study participants, another commonly reported complaint after a MTBI. The PedsQL was designed to measure fatigue in pediatric patients; it includes a General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items), and Cognitive Fatigue Scale (6 items).	Baseline	No
Secondary	Balance Testing	The Balance Error Scoring System (BESS) is a commonly used measure of static balance and postural stability. The test is rapid, relatively easy-to-administer, and inexpensive. A combination of three stances (narrow double leg stance; single leg stance; and tandem stance) and footing surfaces (firm surface/floor or medium density foam) are used for the test. Each stance is held, with hands on hips and eyes closed, for 20 seconds. "Error" points are given for specific behaviors, including opening eyes, lifting hands off hips, or stepping, stumbling, or falling.; Safety Issue: Falls and fall-related injuries. Testing will be supervised by a registered physiotherapist.	Baseline	Yes
Secondary	Neurocognitive Testing	ImPACT is a computerized neuropsychological test battery that consists of six individual test modules that measure multiple aspects of cognitive functioning including attention, memory, working memory, visual scanning, reaction time, and processing speed. The test takes 20-25 minutes. Four composite (i.e., summary) scores are tabulated based upon these individual test scores: Verbal Memory, Visual Memory, Reaction Time, and Processing Speed.	Baseline	No
Secondary	Return to School and Sport	Number of days away from school and sports will be documented. School status will also be rated as part-time, full-time, and with/without accommodations at different time intervals.	Baseline	No
Secondary	Mood	The Beck Depression Inventory for Youth-Second Edition will be used	At 8 weeks (end-of-treatment)	No
Secondary	Energy level	Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale will be used	At 8 weeks (end-of-treatment)	No
Secondary	Balance Testing	The Balance Error Scoring System (BESS) will be used	At 8 weeks (end-of-treatment)	Yes
Secondary	Neurocognitive Testing	ImPACT will be used.	At 8 weeks (end-of-treatment)	No
Secondary	Return to School and Sport	Number of days away from school and sports will be documented. School status will also be rated as part-time, full-time, and with/without accommodations at different time intervals.	At 8 weeks (end-of-treatment)	No