Physiotherapy Program Effect on Musculoskeletal Dysfunctions in Young Football Players

NCT05798988 | Unknown

• 1 other identifier: UKFTVS_LSM_01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Flatfoot, Flexible; Pes Valgus; Pes Varus; Balance; Distorted; Diastasis; Weak; Muscle

Keywords

Dynamic neuromuscular stabilisation; pronated foot; postural stability; neuromuscular control; exercise; sportive children; functional stabilisation; foot function; soccer

Outcome Measures

Primary Outcomes (8)

• 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. 1. 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. 2. 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

Study Arms (2)

Experimental group

EXPERIMENTAL

Experimental group will follow 8 weeks of neurophysiology-based exercise program.

Behavioral: Neurophysiology-based exercise program

Control group

NO INTERVENTION

Control group will receive no intervention. They will not change the movement habits.

Interventions

Neurophysiology-based exercise program BEHAVIORAL

Neurophysiology-based exercise program combines physiotherapy exercises and neuro-physiology principles with focus on foot and core functional stabilisation and balance training.

Experimental group

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• participants playing football at sub- to elite level

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Faculty of Physical Education and Sport, Charles University

Prague, Czechia

RECRUITING

MeSH Terms

Conditions

Flatfoot; Clubfoot; Asthenia; Motor Activity

Condition Hierarchy (Ancestors)

Talipes; Foot Deformities, Acquired; Foot Deformities; Musculoskeletal Diseases; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Limb Deformities, Congenital; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• František Zahálka, prof., Ph.D.

  Faculty of Physical Education and Sport, Charles University

  STUDY DIRECTOR

• Jitka Marenčáková, Ph.D.

  Faculty of Physical Eduction and Sport, Charles University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jitka Marenčáková, Ph.D.

CONTACT

+420605002633; marencakova@ftvs.cuni.cz

František Zahálka, prof., Ph.D.

CONTACT

zahalka@ftvs.cuni.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 5, 2023
• Study Start: January 5, 2023
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: April 5, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be available after 6 months after the first publication for 2 years from the first publication.
• 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.

Locations

CZ (1)