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

NCT ID: NCT02257749

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-12-31

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.

Detailed 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

Conditions

Concussion; Sport-Related Concussion; Mild Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Active Rehabilitation

Active Rehabilitation Intervention and Comprehensive Education Intervention (Standard Care)

Group Type: EXPERIMENTAL

Active Rehabilitation

Intervention Type: OTHER

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.

Comprehensive Education Intervention (Standard Care)

Intervention Type: OTHER

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.

Comprehensive Education Intervention

Comprehensive Education Intervention (Standard Care) only

Group Type: ACTIVE_COMPARATOR

Comprehensive Education Intervention (Standard Care)

Intervention Type: OTHER

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.

Interventions

Active Rehabilitation

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.

Intervention Type: OTHER

Comprehensive Education Intervention (Standard Care)

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Holland Bloorview Kids Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nick Reed, PhD, MSc(OT)

Role: PRINCIPAL_INVESTIGATOR

Holland Bloorview Kids Rehabilitation Hospital/ Bloorview Research Institute

Locations

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 26231756 (View on PubMed)

Other Identifiers

13-459

Identifier Type: -

Identifier Source: org_study_id