Trial Study of an Exercise Program for Youth With Persistent Symptoms After Concussion

Holland Bloorview Kids Rehabilitation Hospital

Status: Terminated

Conditions: Concussion; Sport-Related Concussion; Mild Traumatic Brain Injury

Treatments: Other: Active Rehabilitation; Other: Comprehensive Education Intervention (Standard Care)

Study type: Interventional

Funder types: Other

Identifiers

NCT02257749

13-459

Details and patient eligibility

About

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.

Full description

There is a portion of youth who continue to experience persistent post-concussion symptoms beyond the first few weeks of injury. There is limited evidence with respect to the best ways to treat persistent post-concussion symptoms in youth following concussion. There is a small amount of literature that suggests active rehabilitation as a positive intervention for promotion of recovery of persistent post-concussion symptoms. However, this approach to rehabilitation has yet to be explored using a randomized control trial protocol.

Therefore, this study aims to answer the following question: Is a 6 week active rehabilitation program in combination with a comprehensive education intervention (standard care) effective in reducing post-concussive symptoms and improving functional recovery compared to receiving comprehensive education intervention alone among youth experiencing persistent post-concussion symptoms?

We hypothesize:

1. youth ages 10 to 18 years who present with persistent self-reported post-concussion symptoms 4 weeks after the initial injury and receive the active rehabilitation intervention, will present with decreased post-concussion symptoms at the completion of the intervention.
2. youth ages 10 to 18 years who receive the active rehabilitation intervention, will present with more complete functional recovery and increased participation in unrestricted physical activity at the completion of the active rehabilitation intervention compared to children receiving the comprehensive education intervention only

Enrollment: 1 patient

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1 participants in 2 patient groups

Active Rehabilitation

Experimental group

Description:

Active Rehabilitation Intervention and Comprehensive Education Intervention (Standard Care)

Treatment:

Other: Active Rehabilitation

Other: Comprehensive Education Intervention (Standard Care)

Comprehensive Education Intervention

Active Comparator group

Description:

Comprehensive Education Intervention (Standard Care) only

Treatment:

Other: Comprehensive Education Intervention (Standard Care)