Physiotherapy Program Effect on Musculoskeletal Dysfunctions in Young Football Players

Neurophysiology-based Physiotherapy Program Effect on Selected Musculoskeletal Dysfunctions in Young Football Players

The goal of this clinical study is to test the proposed physiotherapy exercise program in young football players. The main question it aims to answer is:

- Does the proposed physiotherapy program work well in improving young football players movement apparatus functions?

Participants will be asked to fill out questionaires about their musculoskeletal health, physical activity and foot wear and follow the 8 weeks of the group exercise program of 16 sessions in total (2 sessions per week, 30 minutes each session).

Researcher will compare exercising participants with no exercising participants of the same age and football category to see if the exercise program works well in young football players.

Study Overview

• Status: Recruiting
• Conditions: Balance; Distorted; Weak; Muscle; Flatfoot, Flexible; Pes Valgus; Pes Varus; Diastasis
• Intervention / Treatment: Behavioral: Neurophysiology-based exercise program

Detailed Description

The clinical trial aims to evaluate the short and long term effect of proposed neurophysiology-based physiotherapy program (NPP) on selected functional variables of the lower body in young football players, using clinical and laboratory diagnostic methods. Participants will be randomly assigned into one of the two groups: experimental (following 8 weeks of the intervention program) and control group (not changing the movement habits). Proposed NPP combines techniques and concepts based on neurophysiology principles and developmental kinesiology: sensorimotor stimulation and foot exercises, balance training, trunk stabilisation exercise in developmental kinesiology positions. Participants will exercise in small group twice a week in total of 16 sessions, 30 minutes each of session, under the guidance of an experienced physiotherapist. NPP is designed as a step by step progressive exercise program with focus on quality of neuromuscular control. Whole program is implemented into the standard football training process. Data will be obtained pre- (at baseline) and post-intervention (in 2 months and in 5 months) and compared to control group.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jitka Marenčáková, Ph.D.; Phone Number: +420605002633; Email: marencakova@ftvs.cuni.cz
• Study Contact Backup: Name: František Zahálka, prof., Ph.D.; Email: zahalka@ftvs.cuni.cz

Study Locations

• Czechia
  • Prague, Czechia
    • Recruiting
    • Faculty of physical education and sport, Charles University
    • Contact: František Zahálka, prof., Ph.D.; Email: zahalka@ftvs.cuni.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• participants playing football at sub- to elite level

Exclusion Criteria:

• acute infectious disease or fever
• any serious cardiological, neurological, or orthopedic diseases
• acute pain
• injury in the last 3 months
• currently undergoing any other kind of physiotherapy or treatment
• missing two or more sessions of the intervention program

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Experimental group will follow 8 weeks of neurophysiology-based exercise program.	Behavioral: Neurophysiology-based exercise program; Neurophysiology-based exercise program combines physiotherapy exercises and neuro-physiology principles with focus on foot and core functional stabilisation and balance training.
No Intervention: Control group; Control group will receive no intervention. They will not change the movement habits.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Clinical foot type at 2 and 5 months	The foot posture will be assessed using the Foot posture index (6-FPI) evaluating six items (-2 and -1 for supination, 0 for neutral, and +1 and +2 for pronation) with final scores for 5 types of the foot: over-supinated foot (-12 to -5), supinated foot (-4 to -1), neutral foot (0 to +5), pronated foot (+6 to +9), and over-pronated foot (+10 to +12).	at baseline, in 2 months and in 5 months
Change from baseline Calcaneal position in frontal plane at 2 and 5 months	The calcaneal position in frontal plane will be assessed using the Foot posture index (6-FPI) evaluating as one of the six items by points -2 and -1 for calcaneal inversion, 0 for neutral, and +1 and +2 for calcaneal eversion.	at baseline, in 2 months and in 5 months
Change from baseline Medial longitudinal arch (MLA) height at 2 and 5 months	The MLA height will be assessed using the Foot posture index (6-FPI) evaluating as one of the six items by points -2 and -1 for calcaneal inversion, 0 for neutral, and +1 and +2 for calcaneal eversion.	at baseline, in 2 months and in 5 months
Change from baseline Foot morphology at 2 and 5 months	The morphological parameters of the foot will be examined on a full foot 3D scanner (RSscan International, Belgium). A 3D image (scan) of the leg is obtained in two situations: sitting (10% weight-bearing) and resting (50% weight-bearing). In each situation, the proband remains still for the entire time of scanning (about 20 s). First, the measurement is performed while sitting, in a standardized position (90° flexion in the knee and ankle joint, shank vertical, sitting upright, hands on the hips). From a sitting position, the proband stands up in such a way that the weight of the body is distributed ideally evenly on both legs, upright calm standing, hands on the hips. From the obtained 3D data, parameters such as the foot length, foot width, and height of the MLA of the foot will be subtracted (mm).	at baseline, in 2 months and in 5 months
Change from baseline Arch height index at 2 and 5 months	The Arch height index (AHI, %) will be calculated as the ratio of the dorsal MLA height measured at 50% of the truncated foot length and of the truncated foot length, in two positions: 1) AHI in sitting (10%WB) and 2) AHI in standing (50%WB).	at baseline, in 2 months and in 5 months
Change from baseline Foot flexibility at 2 and 5 months	From the AHI values for sitting (10%WB) and for standing (50%WB) and body weight the Arch height flexibility (AHF, mm/kN) will be calculated. AHF evaluates the flexibility of the longitudinal arch independently on the clinical foot type. The basic results determine the flexibility of the foot as normal, rigid or flexible.	at baseline, in 2 months and in 5 months
Change from baseline Postural stability at 2 and 5 months	The measurement will be provided using a pressure plate RS Footscan® (RSscan International, Paal, Belgium) with dimensions of 58x42x1.2 cm with a used imaging frequency of 10 Hz. The assessment will consist of narrow stance (NS) position and single-leg stance (SLS) position.; The NS examination will be performed while standing in a narrow base first with eyes open and then with eyes closed for 33 seconds, with a pause of 30 seconds between the two conditions.; The SLS testing will be performed while standing on the one leg for 60 seconds with repetition on the second leg. There will be a pause of 30 seconds between individual measurements. The parameter Centre of pressure path length (COPP) in millimeters and the maximum deviation achieved in the latero-lateral and antero-posterior directions in millimeters will be evaluated. The parameters are used to evaluate the level of postural stability of the individual.	at baseline, in 2 months and in 5 months
Change from baseline Trunk stabilization function at 2 and 5 months	The trunk stabilization examination will be performed according to the examination protocol of the Dynamic Neuromuscular Stabilization (DNS) concept in the position from developmental ontogenesis - 3rd month lying on the back (Supine test). Evaluation of the quality of trunk stabilization: normal (0), impaired function (1), insufficient function with diastasis (2).	at baseline, in 2 months and in 5 months

Collaborators and Investigators

• Sponsor: Charles University, Czech Republic
• Investigators: Study Director: František Zahálka, prof., Ph.D., Faculty of physical education and sport, Charles University; Principal Investigator: Jitka Marenčáková, Ph.D., Faculty of Physical Eduction and Sport, Charles University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2023
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2025

Study Registration Dates

• First Submitted: March 8, 2023
• First Submitted That Met QC Criteria: March 22, 2023
• First Posted (Actual): April 5, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2023
• Last Update Submitted That Met QC Criteria: March 22, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: exercise; soccer; postural stability; neuromuscular control; foot function; Dynamic neuromuscular stabilisation; pronated foot; sportive children; functional stabilisation
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Talipes; Flatfoot
• Other Study ID Numbers: UKFTVS_LSM_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is planned that the anonymised data will be placed into an online repository (to be specified later)
• IPD Sharing Time Frame: Data will be available after 6 months after the first publication for 2 years from the first publication.
• IPD Sharing Access Criteria: The datasets may be shared on the request and just on the basis of signed Data-Sharing Agreement between the new user and research team. The study team formally reviews access requests for proposals. The use of the datasets by third party can range from direct provision of data, to data analysis collaboration, and/or scientific collaboration.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No