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Evaluation of a Physical Intervention for Persistent Post-Concussive Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03357042
Recruitment Status : Withdrawn (researchers did not find participants to meet the inclusion and exclusion criteria for the testing protocols)
First Posted : November 29, 2017
Last Update Posted : June 1, 2020
Sponsor:
Collaborator:
Northern Ontario School of Medicine
Information provided by (Responsible Party):
Lakehead University

Brief Summary:
A concussion occurs when a person receives an impact to the head. The most common persistent symptoms that generate from a concussion are headaches, depression, lack of balance and dizziness. One recommendation to alleviate persistent symptoms of concussion is rest. Research findings indicate that the benefit of rest is inconclusive to help individuals suffering from a concussion return to activities of daily living. One treatment approach in reducing concussion symptoms is physical exercise therapy. Research findings, however, are limited to treatments being administered before the symptoms are considered persistent. Based on this rationale, the aim of this study is to examine the effect of a physical therapy intervention in minimizing persistent symptoms of concussion using measures of cognition and brain function, mental and physical health, and driving performance. If successful, this physical therapy intervention may help treat persistent concussion symptoms, improving the quality of life and ability for individuals to function normally in their daily lives, and resulting in savings to the healthcare system

Condition or disease Intervention/treatment Phase
Persistent Post-Concussive Syndrome Other: Aerobic exercise and balance retraining Other: Standard of care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Three group: Aerobic retraining intervention, standard of care intervention, healthy control
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-modal Evaluation of a Physical Intervention Approach to Treating Post-Concussive Symptoms
Actual Study Start Date : March 8, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Experimental: Persistent post-concussive symptoms
Participants who report post-concussive symptoms. 20 participants will receive the aerobic exercise and balance training intervention, 20 participants will receive standard of care treatment for concussions.
Other: Aerobic exercise and balance retraining
Aerobic and balance exercises that gradually progress in intensity over the course of 8 weeks.

Other: Standard of care
Normal concussion treatment; physical and cognitive rest

Active Comparator: Healthy control
Persons without post-concussive symptoms. No intervention.
Other: Standard of care
Normal concussion treatment; physical and cognitive rest




Primary Outcome Measures :
  1. Star Excursion Balance Test (SEBT) [ Time Frame: 8 weeks ]
    Measure of balance. Score is based on normalized percentage of maximum reach distance (0-100%) with 100% equal to a perfect score.

  2. Immediate Post-Concussion Assessment Battery [ Time Frame: 8 weeks ]
    Cognitive assessment-Composite score is generated from each subscale by averaging scores, with 100 being equal to a perfect score.

  3. Driving simulator [ Time Frame: 8 weeks ]
    Reaction time to several scenarios will be measured

  4. Oddball task [ Time Frame: 8 weeks ]
    Number of event related potentials will be measured during responses to stimuli

  5. Flanker task [ Time Frame: 8 weeks ]
    Number of event related potentials will be measured during responses to stimuli

  6. Brain-derived neurotropic factor [ Time Frame: 8 weeks ]
    Saliva will be used to analyze brain-derived neurotropic factor



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Man or woman aged 18-50 years.
  2. Reports at least one PCS symptom that is mild in severity.
  3. It has been two weeks since date of injury.

Exclusion Criteria:

  1. Has been previously diagnosed with a psychological/neurological disorder
  2. Has been previously diagnosed with a substance abuse disorder/impairment,
  3. Is currently seeking therapy/counseling
  4. Does not have valid driver's license and 12 months of driving experience.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03357042


Locations
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Canada, Ontario
Fairway Physiotherapy
Thunder Bay, Ontario, Canada, P7B 5E1
Sponsors and Collaborators
Lakehead University
Northern Ontario School of Medicine
Investigators
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Principal Investigator: Sheryl Wark, M.D. Northern Ontario School of Medicine
  Study Documents (Full-Text)

Documents provided by Lakehead University:
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Responsible Party: Lakehead University
ClinicalTrials.gov Identifier: NCT03357042    
Other Study ID Numbers: RP-506-07112017
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Post-Concussion Syndrome
Brain Concussion
Head Injuries, Closed
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Wounds and Injuries
Wounds, Nonpenetrating