The Impact of Eye and Body Training on the Injury Rate of Concussions in Female Soccer Players

NCT06473883 | Not Yet Recruiting

• 1 other identifier: 20240126
• Study Type: interventional
• Target: 209
• Locations: 0 countries
• Sites: N/A

Brief Summary

The research project aims to find out how special training influences the frequency and severity of injuries among female footballers in the top Swiss league. The project also aims to help establish normative values that are specifically tailored to women. The participating clubs will be randomly assigned to a comprehensive pre-season baseline examination with training recommendations based on the performed examinations (intervention group) or control group (normal training). Over the course of the 2024/2025 season, both groups will be compared in terms of the incidence and severity of concussions and musculoskeletal injuries. Initial results will be available in spring 2025 to coincide with the start of the European Women's Football Championship. The investigators' hypothesis is that the training recommendations in the intervention group will lead to a lower incidence of concussions and that the players will show better injury prevention as a result of these exercises.

Conditions

Concussion, Brain; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Incidence of injury frequency

  Injury frequency will be gauged via REDCap questionnaires, capturing date, type, and injured region. Training adherence will be noted: the intervention group reports specific vestibulo-oculomotor and/or neuromuscular exercise minutes, while the control group reports normal training minutes. Concussed players complete the Post-Concussion Symptom Scale (PCSS). The PCSS is designed to quantify the range and severity of symptoms that can occur after a concussion. It helps healthcare professionals monitor changes in symptoms over time and make informed decisions about an individual's recovery and readiness to return to activities.Each symptom is rated on a scale, typically from 0 to 6, where 0 means the symptom is not present and 5-6 indicates severe severity. Questionnaires occur at baseline, 8-week follow-up, and biweekly until season end for all players.

  1 year

Secondary Outcomes (16)

• Clinical cervical spine/jaw exam:

  1 year

• Video-Head Impulse Test (vHIT)

  1 year

• Dynamic Visual Acuity (DVA)

  1 year

• Vestibulo/Oculomotor Screening (VOMS)

  1 year

• Modified Balance Error Scoring System-Test (BESS)

  1 year

Study Arms (2)

Training recommendation

EXPERIMENTAL

The intervention group will receive training recommendations to prevent concussions and other injuries and improve their performance.

Other: Training recommendation

Normal training

NO INTERVENTION

The control group will continue with their regular training without any recommendations for the prevention of head injuries.

Interventions

Training recommendation OTHER

The players in the intervention group are also given specific training recommendations for the prevention of head injuries, which are compiled by experts (sports scientists, physiotherapists and neuroscientists). The exercise selection covers several areas that can be affected after a head injury. Each section contains 8 different exercises with increasing levels of difficulty (3x Basic-3x Intermediate-2x Advanced). The recommendations should be used as a warm-up program throughout the season before each training session. The coach or athletic coach will lead the warm-up program and ensure that each player follows the sequence and completes each phase according to the scheduled weeks. The warm-up program should be conducted as an 8-week cycle.

Training recommendation

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Registered player for a club in the top Swiss soccer league
• No symptoms of acute head injury at the start of the study
• Sufficient language skills to understand the study information and the informed consent form and to answer questionnaires and anamnestic questions correctly.

You may not qualify if:

• Symptomatic chronic diseases (e.g. tumor diseases, diabetes mellitus, cardiovascular diseases) with the exception of osteoarthritis and controlled (normotensively controlled) arterial hypertension
• Pregnancy
• Diagnosis of a psychiatric disorder/disease
• Drug abuse
• For the neuropsychological test: Known learning disability/disorder

Sponsors & Collaborators

• BrainCare Medical Group: lead

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MeSH Terms

Conditions

Brain Concussion; Musculoskeletal Pain

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; Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nina Feddermann-Demont, PD Dr.med

  Medical Director

  STUDY DIRECTOR

Central Study Contacts

Nina Feddermann-Demont, PD Dr. med

CONTACT

+41 44 500 41 50; daniel.agostino@braincare.swiss

Daniel Agostino

CONTACT

+41 44 500 41 50; daniel.agostino@braincare.swiss

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 25, 2024
• Study Start: June 30, 2024
• Primary Completion: October 30, 2024
• Study Completion: September 30, 2025
• Last Updated: June 25, 2024

Record last verified: 2024-06