Flatfoot, FlexibleNCT05798988
Physiotherapy Program Effect on Musculoskeletal Dysfunctions in Young Football Players
A study testing Neurophysiology-based exercise program in people with Flatfoot, Flexible and Pes Valgus, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Flatfoot, Flexible, Pes Valgus, Pes Varus
- What is being tested?
- Neurophysiology-based exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCzechia
- Study dates
- 5 Jan 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- participants playing football at sub- to elite level
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
František Zahálka, prof., Ph.D. contact
Czechia1 site, 1 recruiting
- Recruiting
Faculty of Physical Education and Sport, Charles University
Prague
František Zahálka, prof., Ph.D., zahalka@ftvs.cuni.cz
About this study
Official title: 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.
Read the 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.
- Conditions
- Flatfoot, Flexible, Pes Valgus, Pes Varus, Balance; Distorted, Diastasis, Weak; Muscle
- Being tested
- Neurophysiology-based exercise program
- Keywords
- Dynamic neuromuscular stabilisation, pronated foot, postural stability, neuromuscular control, exercise, sportive children, functional stabilisation, foot function, soccer
- Medical subject headings
- Flatfoot, Clubfoot, Asthenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurophysiology-based exercise programBehavioural
Neurophysiology-based exercise program combines physiotherapy exercises and neuro-physiology principles with focus on foot and core functional stabilisation and balance training.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Experimental group will follow 8 weeks of neurophysiology-based exercise program. Receives: Behavioral: Neurophysiology-based exercise program |
| Control group | No intervention | Control group will receive no intervention. They will not change the movement habits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: at baseline, in 2 months and in 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start5 Jan 2023
- Primary completionJan 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flatfoot, FlexibleStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jitka Marenčáková, Charles University, Czech Republic
- Investigators
- František Zahálka, prof., Ph.D., Study director, Faculty of Physical Education and Sport, Charles UniversityJitka Marenčáková, Ph.D., Principal investigator, Faculty of Physical Eduction and Sport, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798988
- Sponsor's protocol ID
- UKFTVS_LSM_01
- Status last verified
- Mar 2023
- First submitted
- 8 Mar 2023
- Last updated
- 5 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: It is planned that the anonymised data will be placed into an online repository (to be specified later)
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiology-based Physiotherapy Program Effect on Selected Musculoskeletal Dysfunctions in Young Football Players
- ClinicalTrials.gov ID
- NCT05798988
- Acronym / sponsor ID
- UKFTVS_LSM_01
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Neurophysiology-based exercise programExperimental group will follow 8 weeks of neurophysiology-based exercise program. |
| Control group | No intervention | –Control group will receive no intervention. They will not change the movement habits. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- participants playing football at sub- to elite level
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurophysiology-based exercise programNeurophysiology-based exercise program combines physiotherapy exercises and neuro-physiology principles with focus on foot and core functional stabilisation and balance training. | Behavioural | Experimental group |
Primary outcome
Change from Baseline Clinical foot type at 2 and 5 months
Time frame: at baseline, in 2 months and in 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
Time frame: at baseline, in 2 months and in 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
Time frame: at baseline, in 2 months and in 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
Time frame: at baseline, in 2 months and in 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
Time frame: at baseline, in 2 months and in 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
Time frame: at baseline, in 2 months and in 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
Time frame: at baseline, in 2 months and in 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.
Change from baseline Trunk stabilization function at 2 and 5 months
Time frame: at baseline, in 2 months and in 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
- Individual participant dataSharing planned: Yes. It is planned that the anonymised data will be placed into an online repository (to be specified later)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
František Zahálka, prof., Ph.D. contact
František Zahálka, prof., Ph.D. study director
Faculty of Physical Education and Sport, Charles University
Jitka Marenčáková, Ph.D. principal investigator
Faculty of Physical Eduction and Sport, Charles University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurophysiology-based exercise program in people with Flatfoot, Flexible and Pes Valgus, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jitka Marenčáková, Ph.D. (+420605002633, marencakova@ftvs.cuni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Clinical foot type at 2 and 5 months (time frame: at baseline, in 2 months and in 5 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2023.