On Field Functional Rehabilitation -Comparing Two Programs-framework

NCT05163470 | Unknown

• 1 other identifier: statioan1906198402833125882688
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Sport Injury

Keywords

football; Return to sports; injuries; On filed functional rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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 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

  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 Outcomes (1)

• 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.

  For nine months after Return to sports

Study Arms (2)

On Fi.RE. framework

EXPERIMENTAL

Men football professional players

Other: early on filed functional rehabilitation

Traditional rehabilitation

ACTIVE COMPARATOR

Men football professional players

Other: traditional on filed functional rehabilitation

Interventions

early on filed functional rehabilitation OTHER

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.

On Fi.RE. framework

traditional on filed functional rehabilitation OTHER

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.

Traditional rehabilitation

Eligibility Criteria

• Age: 17 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Patras: lead

Study Sites (3)

Stadium of Agios Nikolaos

Agios Nikolaos, Crete, 72100, Greece

RECRUITING

Hymettus Municipal Stadium

Athens, Imittos, 16232, Greece

RECRUITING

Municipal Stadium of Aigion

Aigio, Peloponnese, 25100, Greece

RECRUITING

Related Publications (9)

• Ekstrand J, Krutsch W, Spreco A, van Zoest W, Roberts C, Meyer T, Bengtsson H. Time before return to play for the most common injuries in professional football: a 16-year follow-up of the UEFA Elite Club Injury Study. Br J Sports Med. 2020 Apr;54(7):421-426. doi: 10.1136/bjsports-2019-100666. Epub 2019 Jun 10.

  PMID: 31182429 BACKGROUND

• Ekstrand J, Spreco A, Bengtsson H, Bahr R. Injury rates decreased in men's professional football: an 18-year prospective cohort study of almost 12 000 injuries sustained during 1.8 million hours of play. Br J Sports Med. 2021 Oct;55(19):1084-1091. doi: 10.1136/bjsports-2020-103159. Epub 2021 Feb 5.

  PMID: 33547038 BACKGROUND

• Buckthorpe M, Frizziero A, Roi GS. Update on functional recovery process for the injured athlete: return to sport continuum redefined. Br J Sports Med. 2019 Mar;53(5):265-267. doi: 10.1136/bjsports-2018-099341. Epub 2018 Sep 29. No abstract available.

  PMID: 30269097 BACKGROUND

• Bizzini M, Hancock D, Impellizzeri F. Suggestions from the field for return to sports participation following anterior cruciate ligament reconstruction: soccer. J Orthop Sports Phys Ther. 2012 Apr;42(4):304-12. doi: 10.2519/jospt.2012.4005. Epub 2012 Mar 30.

  PMID: 22467065 BACKGROUND

• Buckthorpe M, Della Villa F, Della Villa S, Roi GS. On-field Rehabilitation Part 2: A 5-Stage Program for the Soccer Player Focused on Linear Movements, Multidirectional Movements, Soccer-Specific Skills, Soccer-Specific Movements, and Modified Practice. J Orthop Sports Phys Ther. 2019 Aug;49(8):570-575. doi: 10.2519/jospt.2019.8952. Epub 2019 Jul 10.

  PMID: 31291556 BACKGROUND

• Della Villa S, Boldrini L, Ricci M, Danelon F, Snyder-Mackler L, Nanni G, Roi GS. Clinical Outcomes and Return-to-Sports Participation of 50 Soccer Players After Anterior Cruciate Ligament Reconstruction Through a Sport-Specific Rehabilitation Protocol. Sports Health. 2012 Jan;4(1):17-24. doi: 10.1177/1941738111417564.

  PMID: 23016064 BACKGROUND

• Taberner M, Allen T, Cohen DD. Progressing rehabilitation after injury: consider the 'control-chaos continuum'. Br J Sports Med. 2019 Sep;53(18):1132-1136. doi: 10.1136/bjsports-2018-100157. Epub 2019 Feb 8. No abstract available.

  PMID: 30737202 BACKGROUND

• Fuller CW, Ekstrand J, Junge A, Andersen TE, Bahr R, Dvorak J, Hagglund M, McCrory P, Meeuwisse WH. Consensus statement on injury definitions and data collection procedures in studies of football (soccer) injuries. Br J Sports Med. 2006 Mar;40(3):193-201. doi: 10.1136/bjsm.2005.025270.

  PMID: 16505073 BACKGROUND

• Stathas I, Kalliakmanis A, Kekelekis A, Danassi Afentaki D, Tsepis E, Fousekis K. Effectiveness of an On-Field Rehabilitation framework for return to sports in injured male professional football players: a single-blinded, prospective, randomised controlled trial. BMJ Open Sport Exerc Med. 2024 Jan 19;10(1):e001849. doi: 10.1136/bmjsem-2023-001849. eCollection 2024.

  PMID: 38268525 DERIVED

Related Links

• Information, affordances, and the control of action in sport

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

• Ioannis Stathas, Bachelor

  student of MSc therapeutic exercise

  STUDY CHAIR

Central Study Contacts

Ioannis Stathas, Bachelor

CONTACT

6945895744; statioan@hotmail.com

Konstantinos Fousekis, PhD

CONTACT

6936767679; kfousekis@upatras.gr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ass.Professor in Sports Physical Therapy

Model Details: The population of the study will be divided randomized in two groups, each of the group it will follow a different functional on field rehabilitation framework in low limb musculoskeletal injuries after sustain an acute injury.The two groups will be divided in subgroups,each of group with the same division ,based on the nature of musculoskeletal injury.A physician,will evaluate the players on initial time of the acute injury and after the compliancy of the rehabilitation.Each of the functional on field rehabilitation framework will be applied from one physiotherapist.All the subject will receive the same physiotherapy treatment ,i.e. manual therapy and specific therapeutic exercise protocol depending of the nature of the injury.After return to sports all the participants will be follow the same prevention program depending of the nature of the injury for two months.

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 20, 2021
• Study Start: July 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: September 30, 2022
• Last Updated: March 28, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (3)