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Physiotherapy Program Effect on Musculoskeletal Dysfunctions in Young Football Players

Primary Purpose

Flatfoot, Flexible, Pes Valgus, Pes Varus

Status
Recruiting
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Neurophysiology-based exercise program
Sponsored by
Charles University, Czech Republic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Flatfoot, Flexible focused on measuring Dynamic neuromuscular stabilisation, pronated foot, postural stability, neuromuscular control, exercise, sportive children, functional stabilisation, foot function, soccer

Eligibility Criteria

11 Years - 18 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of Physical Education and Sport, Charles UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).
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.
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.
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).
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).
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.
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.
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).

Secondary Outcome Measures

Full Information

First Posted
March 8, 2023
Last Updated
March 22, 2023
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT05798988
Brief Title
Physiotherapy Program Effect on Musculoskeletal Dysfunctions in Young Football Players
Official Title
Neurophysiology-based Physiotherapy Program Effect on Selected Musculoskeletal Dysfunctions in Young Football Players
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charles University, Czech Republic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Experimental group will follow 8 weeks of neurophysiology-based exercise program.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group will receive no intervention. They will not change the movement habits.
Intervention Type
Behavioral
Intervention Name(s)
Neurophysiology-based exercise program
Intervention Description
Neurophysiology-based exercise program combines physiotherapy exercises and neuro-physiology principles with focus on foot and core functional stabilisation and balance training.
Primary Outcome Measure Information:
Title
Change from Baseline Clinical foot type at 2 and 5 months
Description
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).
Time Frame
at baseline, in 2 months and in 5 months
Title
Change from baseline Calcaneal position in frontal plane at 2 and 5 months
Description
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.
Time Frame
at baseline, in 2 months and in 5 months
Title
Change from baseline Medial longitudinal arch (MLA) height at 2 and 5 months
Description
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.
Time Frame
at baseline, in 2 months and in 5 months
Title
Change from baseline Foot morphology at 2 and 5 months
Description
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).
Time Frame
at baseline, in 2 months and in 5 months
Title
Change from baseline Arch height index at 2 and 5 months
Description
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).
Time Frame
at baseline, in 2 months and in 5 months
Title
Change from baseline Foot flexibility at 2 and 5 months
Description
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.
Time Frame
at baseline, in 2 months and in 5 months
Title
Change from baseline Postural stability at 2 and 5 months
Description
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.
Time Frame
at baseline, in 2 months and in 5 months
Title
Change from baseline Trunk stabilization function at 2 and 5 months
Description
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).
Time Frame
at baseline, in 2 months and in 5 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jitka Marenčáková, Ph.D.
Phone
+420605002633
Email
marencakova@ftvs.cuni.cz
First Name & Middle Initial & Last Name or Official Title & Degree
František Zahálka, prof., Ph.D.
Email
zahalka@ftvs.cuni.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
František Zahálka, prof., Ph.D.
Organizational Affiliation
Faculty of Physical Education and Sport, Charles University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jitka Marenčáková, Ph.D.
Organizational Affiliation
Faculty of Physical Eduction and Sport, Charles University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Physical Education and Sport, Charles University
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
František Zahálka, prof., Ph.D.
Email
zahalka@ftvs.cuni.cz

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

Physiotherapy Program Effect on Musculoskeletal Dysfunctions in Young Football Players

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