Postural Control in Children and Adolescents After Suffering From a Concussion

NCT03575741 | Withdrawn

• 1 other identifier: 263878
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Brain

Keywords

postural control; rehabilitation; return-to-sport; mTBI

Outcome Measures

Primary Outcomes (1)

• 3D Movement Measurement

  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.

  max. 48, 72, 120, 360 and 720 hours after injury

Secondary Outcomes (2)

• COP Movement

  max. 48, 72, 120, 360 and 720 hours after injury

• Post Concussion Symptom-Scale (PCSS)

  max. 48, 72, 120, 360 and 720 hours after injury

Study Arms (2)

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

Control

Healthy children will be measured in the very same way to collect data of possible matched controls.

Diagnostic Test: Balance Tests

Interventions

Balance Tests DIAGNOSTIC_TEST

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; Patients

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitaet Innsbruck: lead
• Medical University Innsbruck: collaborator

Study Sites (1)

Institut für Sportwissenschaften

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

• Matthias Baumann, Dr.

  Medizinische Universitaet Innsbruck

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: July 3, 2018
• Study Start: October 8, 2018
• Primary Completion: June 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 13, 2019

Record last verified: 2018-05

Locations

AU (1)