On Field Functional Rehabilitation -Comparing Two Programs-framework (FIREframework)

March 10, 2022 updated by: Dr. Konstantinos Fousekis, University of Patras

Effectiveness of a New On Field Rehabilitation Framework for Return to Sport in Injured Elite Football Players - a Prospective Randomized Controlled Trial

Background Nowadays, in elite demanding football, injuries are a delicate issue as affects player's availability for the teams to win games and attain trophies.Following an injury, the appropriate recovery is vital to return athletes quickly and safely to their sport, based on pre injury physical and psychological levels. Delay in rehabilitation can result in prolonged pain and a delayed return to sports, a finding that emphasizes the importance of proper rehabilitation procedure during injury recovery.On field functional rehabilitation, a key point in injury recovery in football , as presented in the definition of rehabilitation ,obtained the interaction of the person with the environment he lives and provide him/her the ability to optimize functionality. Especially in sports, the last one is applied via ecological theory in sports with a wealth of benefits for the player during injury recovery on filed. Ecological theory bring us closer to the sport from a realistic approach , can provide an explanation to many situations that arise in sports and understands the athlete as a part of his/her own surroundings.

Ideally, through injury recovery , the focus should be more on the biological time needed for the injury to recover, while trying to maintain the skills of the athlete during the rehabilitation process. Adequate and appropriate cognitive and neuromuscular skills should be maintained in high level, in activities that normally occurred during training or games. In this Context, application of ecological theory in football on field functional rehabilitation provide to the player the ability to maintain this skills, according with the high demands of elite football players.The maximum retention of football specific skills and the adaptation of injured tissue in an injury football player take place on his/her natural environment of action , the field .

What sports medicine community knows? Until today, disunity of opinions prevalent among sports medicine community about on filed functional rehabilitation during injury recovery.The majority of the clinicians apply on field functional rehabilitation, called as traditional on filed rehabilitation, as the late phase of injury recovery ,where the player comeback on filed activity when he had already restore maximum or the average strength and function based on pre injury screening or standard value.The progression of the player during the late phase of injury recovery based on load monitoring with (global position system) to control progression and risk of reinjury. On the contrary emphasized the opinion of the early return to filed activity that's can increase for the injury player the ability to maintain sports specific skills as much as he can during injury recovery.

In the literature review there is a absence of evidence to refer to a specific framework for on field functional rehabilitation in regard of recovery an injured football player (elite or amateur ) on field. References ,with a lack of evidence ,exist only in some specific rehabilitation protocols such as muscle injury rehabilitation tendons injuries management or Anterior Cruciate Ligament Reconstruction rehabilitation as the late phase of injury recovery.Only one study, present on field functional rehabilitation framework of 5 stages based on traditional rehabilitation for short and long term injuries based on load monitoring through global position system ,as a work based on experience and lacking of evidence.

Aim The overall objective of the proposed research is to conduct a prospective randomized controlled trial to evaluate the effectiveness of ''On FI.RE. framework'' (on filed rehabilitation framework),namely the early return to on field activities during an injury recovery. Included a specific 5 stages program-framework , and a daily session planning framework for on field functional rehabilitation. The effectiveness will evaluated with the time that the player needed to return to full participation in teams training.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Background Nowadays, in elite demanding football, injuries are a delicate issue as affects player's availability for the teams to win games and attain trophies. Injury was defined, using a time-loss definition, as any physical complaint sustained by a player that results from a football match or football training and led to the player being unable to take full part in future football training or match.An elite football team, constituted from about 25 players, presented an injury incident of 6.6./1000 hours of exposure, (decreased 3% the last years) . Following an injury, the appropriate recovery is vital to return athletes quickly and safely to their sport, based on pre injury physical and psychological levels. Delay in rehabilitation can result in prolonged pain and a delayed return to sports, a finding that emphasizes the importance of proper rehabilitation procedure during injury recovery .

Rehabilitation is defined as a set of interventions designed to optimize function and reduce disability in individuals with healthy conditions in interaction with their environment.This interaction refers to the observation of animals , so in fact the person, as the animals, has the ability to execute an action or movement based on the environment he lives.The last one is applied in ecological theory in sports with a wealth of benefits for the player during training or injury recovery on filed. Ecological theory bring us closer to the sport from a realistic approach , can provide an explanation to many situations that arise in sports,understands the athlete as a part of his/her own surroundings where there is only perception and action and also presented the large degree of freedom that can exist in a movement which surpasses the conscious capacity of control in nervous system.

Ideally, through injury recovery , the focus should be more on the biological time needed for the injury to recover, while trying to maintain the skills of the athlete during the rehabilitation process.Adequate and appropriate cognitive and neuromuscular skills should be maintained in high level, in activities that normally occurred during training or games. In this Context, application of ecological theory in football on field functional rehabilitation provide to the player the ability to maintain this skills, according with the high demands of elite football players.The successful persistence of athlete skills during injury rehabilitation and decision making process will come through neuroplasticity which exerts an important role and allows to correct, modify, and adapt neuromuscular patterns, allowing the athlete to protect the injured part during the biological time needed for it to heal and to maintain the sports skills.This would allow adaption and healing of the injured tissue, restoring as quickly as possible the specific movements or loads expected from the injured muscle or joint.The maximum retention of football specific skills and the adaptation of injured tissue in an injury football player take place on his/her natural environment of action , the field.

What sports medicine community knows? Until today, disunity of opinions prevalent among sports medicine community about on filed functional rehabilitation during injury recovery.The majority of the clinicians apply on field functional rehabilitation, called as traditional on filed rehabilitation, as the late phase of injury recovery ,where the player comeback on filed activity when he had already restore maximum or the average strength and function based on pre injury screening or standard value.The progression of the player during the late phase of injury recovery based on load monitoring with global position system to control progression and risk of reinjury.In oone study traditional rehabilitation is described and analyzed more specifically as the overlap period between the rehabilitation and return to sports .On the contrary emphasized that the early return to filed activity for the injury player to maintain sports specific skills as much as he can during injury recovery.

In the literature review there is a absence of evidence to refer to a specific framework for on field functional rehabilitation in regard of recovery an injured football player (elite or amateur ) on field. References ,with a lack of evidence ,exist only in some specific rehabilitation protocols such as muscle injury rehabilitation tendons injuries management or Anterior Cruciate Ligament Reconstruction rehabilitation as the late phase of injury recovery. In one study, presented on field functional rehabilitation framework of 5 stages based on traditional rehabilitation for short and long term injuries based on load monitoring through global position system as a work based on experience and lacking of evidence.

Aim The overall objective of the proposed research is to conduct a prospective randomized controlled trial to evaluate the effectiveness of ''On FI.RE. framework'' (on filed rehabilitation framework),namely the early return to on field activities during an injury recoveryIncluded a specific 5 stages program-framework , and a daily session planning framework for on field functional rehabilitation. The effectiveness will be evaluated with the time that the player will be needed to return to full participation in teams training.

Protocol The eligible study population will consist of men professional football players that participate in Greek football professional categories ,between 17-40 years old ,with an acute low limb musculoskeletal injury that sustained in game or training. Participants of the study will be divided in two groups. One group will be treated with 'On FI.RE. framework' during on field functional rehabilitation and the other group(control group)will be treated with 'traditional rehabilitation' framework. Each group will be categorized in subgroups based on the nature of injury such as muscle tear, ligament tear, acute overuses syndromes and fractures or cartilage lesions. All players fulfilling the inclusion and not meeting the exclusion criteria will be asked to participate in the study. After the player´s enrolment has been confirmed and informed consent is obtained a set of questionnaires is provided for background data on medical history based on football federation medical examination paper. A physician will make the evaluation and diagnostic imaging prescription to make a diagnosis of the injury . When the procedure is completed, the patient is randomized. One physiotherapist, different for each group, will apply the general(physiotherapy and exercises in the Gym) and specific(on filed functional rehabilitation) program. The intervention program analyzed in chapter 8. If a player don't complete or quit from the procedure he will withdraw for the data collection. After the completion of the rehabilitation program the physician will evaluate the player to permit or not, the full participation in team training. After the return of player's to team training will follow a secondary prevention program for two months. Participation in this study will last maximum twelve months.

Statistical analysis plan To address the primary and secondary objectives, a statistical analysis by using statistical package for the social sciences will be performed. Depending on the data distribution ,a X² test or Mann-Whitney U test will be applied to calculate the means between the two groups based on time player needed to return in team training.

The importance of the presented study lie on the presentation and development of evidence in clinical practice regarding the ideal of on field functional rehabilitation framework ,for low limb musculoskeletal injuries for professional football players in the matter of faster and safety return to play.

Study Type

Interventional

Enrollment (Anticipated)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Greece
    • Crete
      • Agios Nikolaos, Crete, Greece, 72100
        • Recruiting
        • Stadium of Agios Nikolaos
        • Contact:
    • Imittos
      • Athens, Imittos, Greece, 16232
        • Recruiting
        • Hymettus Municipal Stadium
        • Contact:
          • Chiotakis Panagiotis
          • Phone Number: +0030 6981038246
    • Peloponnisos
      • Aigio, Peloponnisos, Greece, 25100
        • Recruiting
        • Municipal Stadium of Aigion
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Subject/player he will be a professional player at least 3 years
  • The musculoskeletal injury to be an acute injury
  • The player participate in the study from the initial tine that injury occurred
  • The injury to be moderate or severe (≥ 7 days ) as the initial diagnosis (1)

Exclusion Criteria:

  • A reinjury of a previous injury
  • Chronic overuse syndrome or other disorders that affect the intervention and the result of the study
  • Do not sustained another injury the last two months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: On Fi.RE. framework
Men football professional players
Other: early on filed functional rehabilitation
Intervention 1 ,called ''On FI.RE. framework '' included a on filed functional rehabilitation framework ,with early return of the player on the field activities during injury recovery. Involve a specific 5 stages framework of functional rehabilitation on filed. Criteria of inclusion and exclusion for each stage are included based on pain, oedema and range of motion specific to nature of injury . Additional included a daily session planning framework for on field functional rehabilitation with a content ,duration and the description of each content.
Active Comparator: Traditional rehabilitation
Men football professional players
Other: traditional on filed functional rehabilitation
Intervention 2 ,called 'traditional rehabilitation' include a on field functional rehabilitation framework ,as the late phase of injury recovery .The framework described as a 5 stages on filed rehabilitation framework based on load monitoring usingGlobal positioning system.No criteria for the player to return to activity on the field cited ,but referred criteria for progression in each stage based on Strength/power depending of the nature of injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary outcome measure is time to return, that is, time that the player needed from injury to full participation in the team training process based on pre injury physical level.
Time Frame: Direct after rehabilitation completion
Time to return ,namely loss days ,is defined as the period of absence for a player following an injury constituted the full period (number of days) between the date when the player was forced to discontinue his football participation due to an injury until the date when the medical team allowed the player to return to full participation in team training.After the completion of the measurement , means of the total number of days that players of each group needed to return to full participation in team training will be compared between groups to evaluate which of the two interventions is more effective.
Direct after rehabilitation completion
Time to return-subgroups
Time Frame: Direct after rehabilitation completion
After the completion of the measurement , means of the total number of days that players of each subgroup (based on th nature of injury) needed to return to full participation in team training will be compared between subgroups of two arms to evaluate which of the two interventions is more effective.
Direct after rehabilitation completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of reinjuries, injury of the same type and at the same site as an index injury, was registered during a 2 month period after the player return to performance.
Time Frame: For nine months after Return to sports
''Early recurrence'' ,a recurrent injury occurring within 2 months of a player's return to full participation and ''late recurrence'' a recurrent injury occurring 2 to 12 months after a player's return to full participation,with the team in games will be documented. The result it will be compared between groups .
For nine months after Return to sports

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Patras

Investigators

  • Study Chair: Ioannis Stathas, Bachelor, student of MSc therapeutic exercise

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

December 31, 2021

Study Completion (Anticipated)

September 30, 2022

Study Registration Dates

First Submitted

December 6, 2021

First Submitted That Met QC Criteria

December 6, 2021

First Posted (Actual)

December 20, 2021

Study Record Updates

Last Update Posted (Actual)

March 28, 2022

Last Update Submitted That Met QC Criteria

March 10, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • statioan1906198402833125882688

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The subjects are professional football players and their data aren't permitted to be published

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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