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临床试验/NCT06473883
NCT06473883尚未招募不适用

Effects of Vestibulo-oculomotor and Neuromuscular Training on the Incidence of Concussions and Musculoskeletal Injuries in Competitive Female Football Players

BrainCare Medical Group0 个研究点目标入组 209 人开始时间: 2024年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
209
主要终点
Incidence of injury frequency

研究概览

简要总结

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.

详细描述

All clubs in the top women's league in football will be contacted and asked to take part in the study. The baseline examinations will ideally take place in June and August 2024 to allow sufficient time to implement the training recommendations. The baseline examinations include a range of assessments addressing various systems potentially impacted by a concussion. These assessments encompass a standardized questionnaire, as well as vestibular, neurocognitive, balance, neck, and neurological evaluations.

Due to the availability of the players, baseline examinations may also have to take place in September. The players in the intervention group are also given specific training recommendations for the prevention of head injuries, which are compiled by experts (neurologists, 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.

The exercises are sent to the coaching staff in writing and by means of a video using our Neuroreha-Tool app. The coaches have access to the specific prescribed exercises. Each exercise is repeated 2-3 times and each exercise takes 50 seconds. In total, the warm-up will take 10-15 minutes.

During the football season from August 2024 to April 2025, players (both intervention and control groups) will be asked every two weeks to submit information about any injuries sustained in the match via the My REDCap app or the REDCap online survey. In the event of an injury, the date, type, and injured body region will be recorded via REDCap. Training adherence will also be documented for both groups (intervention group: number of training minutes for specific vestibulo-oculomotor and/or neuromuscular training exercises; control group: minutes of regular training).

After 8 weeks, a follow-up of the standard baseline tests will be repeated to measure the effects of the training recommendations. Each player receives a short report on the results of their examination within one week of the follow-up examination.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Investigator)

入排标准

性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Incidence of injury frequency

时间窗: 1 year

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.

次要结局

  • Clinical cervical spine/jaw exam:(1 year)
  • Dynamic Visual Acuity (DVA)(1 year)
  • Vestibulo/Oculomotor Screening (VOMS)(1 year)
  • Video-Head Impulse Test (vHIT)(1 year)
  • Postural Control - Sway path length(1 year)
  • Horizontal smooth pursuit gain(1 year)
  • Pupillometry - Amplitude(1 year)
  • Dual Task - Concussion Balance Test (COBALT)(1 year)
  • Modified Balance Error Scoring System-Test (BESS)(1 year)
  • Postural Control - sway path velocity(1 year)
  • Latency in vertical saccades(1 year)
  • Velocity in vertical saccades(1 year)
  • Pupillometry - Velocity(1 year)
  • Latency in horizontal saccades(1 year)
  • Velocity in horizontal saccades(1 year)
  • Vertical smooth pursuit gain(1 year)

研究者

发起方
BrainCare Medical Group
申办方类型
Other
责任方
Sponsor

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