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Postural Control in Children and Adolescents After Suffering From a Concussion

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ClinicalTrials.gov Identifier: NCT03575741
Recruitment Status : Recruiting
First Posted : July 3, 2018
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Medical University Innsbruck
Information provided by (Responsible Party):
Universitaet Innsbruck

Brief Summary:
Sport-related concussions occur during different types of sport and are still an underestimated brain injury. Especially children are affected due to their lacking movement control and thereby at higher risk of situations leading to concussion. However, research about the rehabilitation of balance and coordination in children after sustaining a concussion is lacking. Therefore, the return-to-sport question cannot be answered reliable due to the missing understanding of the underlying mechanisms disturbing coordination, yet. Analyzing postural control, meaning the ability of the body controlled by the brain to maintain balanced, is suggested to be a valid method to investigate movement coordination. A newer method to analyze postural control using reflective marker data will be used to study the rehabilitation process. The findings may help to improve concussion treatment and give implication to the return-to-sport decision. The investigators expect to see an altered postural control after sustaining a concussion visible in the movement amplitude especially short after the injury. Moreover, the researchers assume coordination patterns which are not visible to be altered for an extended time period of up to 30 days as well. Participants will be children aged 10 to 16 years and the aim is to recruit 30 children and adolescents who suffer from a concussion. The data of the concussed participants will be compared with data of healthy volunteers.

Condition or disease Intervention/treatment
Concussion, Brain Diagnostic Test: Balance Tests

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Postural Control in Children and Adolescents After Suffering From a Concussion: Implications for the Return to Sport Decision and for Rehabilitative Measures
Actual Study Start Date : October 8, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Group/Cohort Intervention/treatment
Patients
After suffering from a concussion patients will be investigated 48 h, 72 h, 120 h, 360 h and 720 h after sustaining the injury. Postural control will be measured using 7 different easy balance tests.
Diagnostic Test: Balance Tests

Following balance exercises will be performed by the participants:

  1. Bipedal, hip wide stand, eyes open and hands on hips, 60sec
  2. Bipedal, hip wide stand, eyes closed, hands on hips, 30sec
  3. Tandem-stand, eyes open, hands on hips, 60sec (front foot chosen by participant)
  4. Tandem-stand, eyes closed, hands on hips, 30sec (same front foot)
  5. One-leg-stand, eyes open, hands on hips, 30sec (randomized supporting leg)
  6. One-leg-stand, eyes open, hands on hips, 30sec (other leg)
  7. Bipedal, hip wide stand, eyes open, hands on hips, counting backwards in steps of two (367 - 365 - 363 - ...), 60sec

The rest between the trials will last for at least 30sec, but can be extended by the participants as long as they want. The overall measurement will not exceed 30 minutes.


Control
Healthy children will be measured in the very same way to collect data of possible matched controls.
Diagnostic Test: Balance Tests

Following balance exercises will be performed by the participants:

  1. Bipedal, hip wide stand, eyes open and hands on hips, 60sec
  2. Bipedal, hip wide stand, eyes closed, hands on hips, 30sec
  3. Tandem-stand, eyes open, hands on hips, 60sec (front foot chosen by participant)
  4. Tandem-stand, eyes closed, hands on hips, 30sec (same front foot)
  5. One-leg-stand, eyes open, hands on hips, 30sec (randomized supporting leg)
  6. One-leg-stand, eyes open, hands on hips, 30sec (other leg)
  7. Bipedal, hip wide stand, eyes open, hands on hips, counting backwards in steps of two (367 - 365 - 363 - ...), 60sec

The rest between the trials will last for at least 30sec, but can be extended by the participants as long as they want. The overall measurement will not exceed 30 minutes.





Primary Outcome Measures :
  1. 3D Movement Measurement [ Time Frame: max. 48, 72, 120, 360 and 720 hours after injury ]
    Kinematic movement of markers will be recorded by tracking the coordinates in a 3-dimensional manner using an 8-camera Vicon Bonita system (Vicon Peak, Oxford Metrics ltd., Great Britain). Thirty-nine reflective surface-markers will be distributed on the volunteer's bodies. The markers will be attached using double-sided tape and will be placed directly on the skin where possible. Otherwise, they will be attached to tight sport clothing. The marker based motion capturing system measures with 250 Hz.


Secondary Outcome Measures :
  1. COP Movement [ Time Frame: max. 48, 72, 120, 360 and 720 hours after injury ]
    The participants will stand on a forceplate which is able to record the movement of the Center of Pressure data of the volunteers standing on the plate.

  2. Post Concussion Symptom-Scale (PCSS) [ Time Frame: max. 48, 72, 120, 360 and 720 hours after injury ]
    PCSS is used to evaluate the subjective well-being of the participants after sustaining a mild traumatic brain injury.



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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential participants for the examination of movement control after a mTBI will be screened by involved physicians at the children station of the Tirol Kliniken. If a concussion occurred and the children were assessed as eligible for the study by the medical professionals, patients and their parents or legal guardians will be informed about the study by a physician who is a member of the project-team.
Criteria

Inclusion Criteria:

  • diagnose of mild traumatic brain injury
  • no further stationary medical treatment is needed
  • still in recovery time after sustaining concussion (recruitment phase: day 1-3 after concussion)
  • age range: 10 - 16

Exclusion Criteria:

  • other injuries that require treatment
  • any other known impairments that may affect balance
  • previous concussion in the last 6 months
  • medication will be documented but only excludes if affecting balance

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): NCT03575741


Contacts
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Contact: Felix Wachholz, MSc 00436764773914 felix.wachholz@uibk.ac.at
Contact: Peter A. Federolf, Prof. Dr. 0043512 507 45862 peter.federolf@uibk.ac.at

Locations
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Austria
Institut für Sportwissenschaften Recruiting
Innsbruck, Tyrol, Austria, 6020
Contact: Felix Wachholz, MSc    00436764773914    felix.wachholz@student.uibk.ac.at   
Contact: Peter Federolf, Prof    004351250745862    peter.federolf@uibk.ac.at   
Sponsors and Collaborators
Universitaet Innsbruck
Medical University Innsbruck
Investigators
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Principal Investigator: Matthias Baumann, Dr. Medizinische Universitaet Innsbruck

Additional Information:

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Responsible Party: Universitaet Innsbruck
ClinicalTrials.gov Identifier: NCT03575741     History of Changes
Other Study ID Numbers: 263878
First Posted: July 3, 2018    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: May 2018
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

Keywords provided by Universitaet Innsbruck:
postural control
rehabilitation
return-to-sport
mTBI

Additional relevant MeSH terms:
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Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating