Recruiting

Exercise

Sponsor:

University of British Columbia

Code:

NCT02031068

Conditions

Sport-related Concussion

Concussion

Mild Traumatic Brain Injury (MTBI)

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

Interventions

Active Rehabilitation Program

Treatment-as-usual (TAU)

Study Details

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.

Conditions

Sport-related Concussion

Concussion

Mild Traumatic Brain Injury (MTBI)

Study ID

NCT02031068

Start date

Dec, 2013

Status verified date

Apr, 2015

Completion date

Feb, 2016

Anticipated

Primary completion date

Feb, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 18

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Treatment-as-usual (TAU)

The TAU program will be implemented after the initial assessment. It will consist of 2 components:

1. An initial education session by an occupational therapist, relating to outcome from concussion and managing symptoms
2. A school consultation to provide teacher education, recommend accommodations, and facilitate return to school

experimental: 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:

1. Sub-maximal aerobic training for up to 15 minutes
2. Light coordination and sport-specific exercises for up to 10 minutes
3. Visualization and imagery techniques
4. Home program.

A physiotherapist will supervise the rehabilitation.

Interventions

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:

1. Sub-maximal aerobic training for up to 15 minutes
2. Light coordination and sport-specific exercises for up to 10 minutes
3. Visualization and imagery techniques
4. 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

Primary outcome measure

  • Symptom Report [ Time Frame: Baseline ]
  • Symptom Report [ Time Frame: At 8 weeks (end-of-treatment) ]

Central Contacts and Locations

Central contacts

Catherine Chan, MPT

(604) 734-1313Catherine.chan2@vch.ca

Locations

GF Strong Rehabilitation Centre

Recruiting

Vancouver, British Columbia, Canada, V5Z 2G9

Contacts

Catherine Chan, MPT

(604) 734-1313Catherine.chan2@vch.ca

Principal Investigator:

Catherine Chan, MPT

More Information

Sponsor

University of British Columbia

Last update posted

Apr 8, 2015

Last verified

Apr, 2015

Keywords

  • active rehabilitation
  • exercise
  • concussion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2015-04-08.