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

Mild Traumatic Brain Injury Clinical Trial

Official title:

Comparing Active Rehabilitation to a Comprehensive Education Intervention for Youth With Persistent Post-concussion Symptoms Following Concussion.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02257749
• Other study ID #: 13-459
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2017

Study information

• Verified date: March 2022
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion
• Mild Traumatic Brain Injury
• Sport-Related Concussion

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	Mood	The Beck Depression Inventory for Youth- Second Edition will be used. This is a screen that was designed for youth and provides insight into negative thoughts and feelings towards self, life and future.	Week 0 (Baseline)
Secondary	Mood	The Beck Depression Inventory for Youth- Second Edition will be used. This is a screen that was designed for youth and provides insight into negative thoughts and feelings towards self, life and future.	Week 6 (upon completion of the intervention)
Secondary	Behavior	The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth.	Week 0 (Baseline)
Secondary	Behavior	The Child Behavior Checklist will be used. It is designed to identify emotional and behavioral concerns in youth.	Week 6 (upon completion of the intervention)
Secondary	Energy Level	Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue	Week 0 (Baseline)
Secondary	Energy Level	Pediatric Quality of Life Multidimensional Fatigue Scale will be used to examine fatigue	Week 6 (upon completion of the intervention)
Secondary	Quality of Life Level	Pediatric Quality of Life Generic Module will be used to look at quality of life	Week 0 (Baseline)
Secondary	Quality of Life Level	Pediatric Quality of Life Generic Module will be used to look at quality of life	Week 6 (upon completion of the intervention)
Secondary	SCAT Balance	Sport Concussion Assessment Tool- 3rd Edition Balance Subtest will be used. This measure looks at static balance and postural stability. Youth are asked to perform three different stances on a firm surface for 20 seconds each.	Week 0 (Baseline)
Secondary	Balance	Bruininks-Oseretsky Test of Motor Proficiency, Second Edition Balance Subtest will be used. This is used to assess static and dynamic balance with focus on the youth's anticipatory postural control.	Week 0 (Baseline)
Secondary	Balance	Bruininks-Oseretsky Test of Motor Proficiency, Second Edition Balance Subtest will be used. This is used to assess static and dynamic balance with focus on the youth's anticipatory postural control.	Week 6 (upon completion of the intervention)
Secondary	Neurocognitive	ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion.	Week 0 (Baseline)
Secondary	Neurocognitive	ImPACT testing will be done. This is a computer based program designed to assess multiple aspects of cognitive functioning following a concussion.	Week 6 (upon completion of the intervention)
Secondary	Anxiety	State Trait Anxiety Scale will be used to look at parental anxiety	Week 0 (Baseline)
Secondary	Anxiety	State Trait Anxiety Scale will be used to look at parental anxiety	Week 6 (upon completion of the intervention)
Secondary	Activity Participation	Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.	Week 0 (Baseline)
Secondary	Satisfaction Level	Pediatric Quality of Life Health Care Satisfaction Generic Module will be used to gain an understanding of the participants' perceptions of the quality and effectiveness of the intervention.	Week 0 (Baseline)
Secondary	Acute Concussion Evaluation	Acute Concussion Evaluation will be used to collect demographic information such as characteristics of the injury, signs and symptoms of the injury, and risk factors that may predict prolonged recovery.	Week 0 (Baseline)
Secondary	Occupational Performance	The Canadian Occupational Performance Measure will be used to identify occupational performance issues as a platform for goal setting. Participants' rate their satisfaction and performance in self-identified activities that they would like to improve their satisfaction and performance in.	Week 0 (Baseline)
Secondary	Occupational Performance	Participants re-rate their satisfaction and performance in the three areas they self-identified as occupational concerns at week 0 (baseline)	Week 6 (upon completion of the intervention)
Secondary	Balance	Sport Concussion Assessment Tool- 3rd Edition Balance Subtest will be used. This measure looks at static balance and postural stability. Youth are asked to perform three different stances on a firm surface for 20 seconds each.	Week 6 (upon completion of intervention)
Secondary	Activity Participation	Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.	Week 6 (upon completion of the intervention)
Secondary	Activity Participation	Physical Activity Questionnaire for Children and Adolescents will be used to look at the physical activities performed in the 7 days prior to evaluation.	Week 2
Secondary	Satisfaction Level	Pediatric Quality of Life Health Care Satisfaction Generic Module will be used to gain an understanding of the participants' perceptions of the quality and effectiveness of the intervention.	Week 6 (upon completion of the intervention)