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Neurophysiology-based Intervention of Foot Dysfunction in Sportive Children

Primary Purpose

Flatfoot, Flexible, Sports Physical Therapy, Child Development

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

About this trial

This is an interventional treatment trial for Flatfoot, Flexible

Eligibility Criteria

9 Years - 10 Years (Child)MaleAccepts Healthy Volunteers

Inclusion Criteria: age 9-10 years playing football at least for one year and train twice a week FPI above 5 CSI above 45.1% Exclusion Criteria: acute pain, injury injury of musculoskeletal system (past 6 months) infectious disease cardiovascular, metabolic, neurologic or orthopaedic diseases active wearing the orthotic devices or aids or barefoot shoes previous surgery on the lower limbs or pelvis

Sites / Locations

  • Faculty of Physical Education and Sport, Charles University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercising participants

Arm Description

Participants will receive 4 weeks of neurophysiology-based intervention, forty-five minutes of individual session, twice a week.

Outcomes

Primary Outcome Measures

Change from baseline Foot type at 4 weeks
The foot type was assessed using the reliable and valid clinical test Foot posture index (6-FPI) which examine 6 items of the foot: talar head position, inversion/eversion of the calcaneus, talonavicular bulging, medial longitudinal arch height, forefoot abd/adduction, each by the point 0 for neutral, +1 and +2 for pronated, and -1 and -2 for supinated position as defined by Redmont et al. (2008). Total score of the 6 items defines foot type as neutral (0 to +5), pronated (+6 to +9), over-pronated (+10 to +12), supinated (-1 to -4) and over-supinated (-5 to -12).
Change from baseline Medial longitudinal arch height at 4 weeks
The medial longitudinal arch height (MLAH) was assessed by Chippaux-Smirak index (CSI) from digital foot print obtained from pressure mat during single-leg standing. The software Kinovea was used for the normalization the foot print to real foot size and measuring the widest part of the forefoot and the narrowest part of the midfoot in millimeters. Finally, the index was calculated: the narrowest part was divided by widest part and multiply by 100 to obtain total percentage. Total percentage of the CSI ranges in 5 types of MLAH: high 0-0.1%, normal 0.1-29.9%, transitional 30-39.9%, lowered 40-45%, mild flat 45.1-50%, moderate flat 50.1-60%, severe flat 60.1-100% (Onodera et al., 2008; Nikolaidou and Boudolos, 2006).
Change from baseline Foot dynamic function at 4 weeks
The foot dynamic function was measured by Centre of pressure excursion index (CPEI) during normal walking on pressure platform RS Footscan (Gait 7.7). The imposed digital footprint with centre of pressure (COP) trajectory was firstly normalised for the real foot size and measured in software Kinovea to obtain the foot measures: Line A connect the initial point and final point of the COP trajectory, line B was drawn perpendicular to the line A in the widest part of the forefoot, line C was a partial section of the line B between crossing points with line A and COP trajectory. Final calculation of CPEI was done: Line C divided by line B multiplied 100 to obtain total percentage. According to previous studies (Hillstrom et al., 2013; Song et al., 1996), the sample results were divided into thirds: CPEI 10-24.9% for over-pronation, CPEI 25-34.9% for optimal function, and CPEI above 35% for supinated function.
Change from baseline Postural stability at 4 weeks
The postural stability function in single-leg stance was measured on pressure platform RS Footscan (Balance 7.6). Participant stood up on the mat 1.5 m far from the wall, watching the point on the wall in the height of his eyes and flexed non-tested leg up to 90° with thigh still in vertical position. Participant was instructed to stand steadily without moving for 60 s with eyes open. After the rest, participant repeated the same measurement on the other side. Centre of pressure path (COPP) length in millimeters was obtained for both legs.
Core stabilization function
The core stabilization function was assessed by clinical test according to protocol of dynamic neuromuscular stabilisation concept (Kolar et al., 2009) in developmental kinesiology position in supine with legs flexed and raised up and experienced physiotherapist observed the quality of the muscle coordination in stabilisation of the trunk and abdominal wall. The quality of the function was defined as these: 1) optimal function (not co-movements of the region, homogenous abdominal wall, harmonic activation aóf all local and global stabilisers), 2) weakened function (not homogenous abdominal wall, light lumbar movement up) and 3) dysfunction with diastasis (insufficiency of the deep abdominal muscle, over-activation m. rectus abdominis, lumbar spine above the ground, movement and instability of the whole region, diastasis).

Secondary Outcome Measures

Full Information

First Posted
May 23, 2023
Last Updated
June 5, 2023
Sponsor
Charles University, Czech Republic
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1. Study Identification

Unique Protocol Identification Number
NCT05902091
Brief Title
Neurophysiology-based Intervention of Foot Dysfunction in Sportive Children
Official Title
Neurophysiology-based Intervention Program in Sportive Children With Foot Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 10, 2016 (Actual)
Primary Completion Date
September 5, 2017 (Actual)
Study Completion Date
September 20, 2018 (Actual)

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 the clinical trial study is to test the effect of the individual complex physiotherapy intervention program in the children actively playing soccer with flatfoot or valgus foot. The aims are: see if the medial longitudinal arch will by actively more higher after the intervention see if the type of the foot will change toward more neutral type after the intervention see if the transfer of the centre of body mass through the foot during the gait will directed in more neutral line after the intervention The participants will undergo clinical assessment of short kinesiology assessment visually in underwear and barefoot. Then Participant will be tested for balance test in narrow stance with open and closed eyes, and single.leg stance with open eyes on the pressure mat. Finally, participant will walking in self-selected normal speed through the gait pressure mat. Eaxh procedure will be measured twice, before the program start and after the 4 weeks when the program finish. Researchers will compare these two measurement for the changes.
Detailed Description
The aim of the study was to evaluate the effect of the neurophysiology-based (NB) intervention program in sporting children with foot problems. The NB intervention composed from evidence based and neurophysiology-based methods: 1) Janda´s sensorimotor stimulation, 2) Dynamic neuromuscular stabilisation concept (DNS), 3) Toe and foot muscle strengthening, 4) foot support base related exercises, and 5) somatic-sensory facilitation techniques. The proposed NB intervention lasted 4 weeks with each 45minutes long session twice a week. Each session was leaded by experienced physiotherapist in clinical practice gym, in one-to-one regime to ensure quality of the exercising, using progressive steps and some additional balance pads and small ball. The research assessments were conducted pre- and post-intervention (T0 and T4) and consisted of personal data and health questionnaires (name, date of the birth, laterality, shoe size, diseases, injuries and surgery), clinical examining (standing posture, core stabilisation function in supine position, foot posture index), laboratory testing (postural stability and normal walking on pressure mat). Data were edited, analysed and compared pre- and post-intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flatfoot, Flexible, Sports Physical Therapy, Child Development

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercising participants
Arm Type
Experimental
Arm Description
Participants will receive 4 weeks of neurophysiology-based intervention, forty-five minutes of individual session, twice a week.
Intervention Type
Behavioral
Intervention Name(s)
Neurophysiology-based intervention
Primary Outcome Measure Information:
Title
Change from baseline Foot type at 4 weeks
Description
The foot type was assessed using the reliable and valid clinical test Foot posture index (6-FPI) which examine 6 items of the foot: talar head position, inversion/eversion of the calcaneus, talonavicular bulging, medial longitudinal arch height, forefoot abd/adduction, each by the point 0 for neutral, +1 and +2 for pronated, and -1 and -2 for supinated position as defined by Redmont et al. (2008). Total score of the 6 items defines foot type as neutral (0 to +5), pronated (+6 to +9), over-pronated (+10 to +12), supinated (-1 to -4) and over-supinated (-5 to -12).
Time Frame
at baseline and in 4 weeks
Title
Change from baseline Medial longitudinal arch height at 4 weeks
Description
The medial longitudinal arch height (MLAH) was assessed by Chippaux-Smirak index (CSI) from digital foot print obtained from pressure mat during single-leg standing. The software Kinovea was used for the normalization the foot print to real foot size and measuring the widest part of the forefoot and the narrowest part of the midfoot in millimeters. Finally, the index was calculated: the narrowest part was divided by widest part and multiply by 100 to obtain total percentage. Total percentage of the CSI ranges in 5 types of MLAH: high 0-0.1%, normal 0.1-29.9%, transitional 30-39.9%, lowered 40-45%, mild flat 45.1-50%, moderate flat 50.1-60%, severe flat 60.1-100% (Onodera et al., 2008; Nikolaidou and Boudolos, 2006).
Time Frame
at baseline and in 4 weeks
Title
Change from baseline Foot dynamic function at 4 weeks
Description
The foot dynamic function was measured by Centre of pressure excursion index (CPEI) during normal walking on pressure platform RS Footscan (Gait 7.7). The imposed digital footprint with centre of pressure (COP) trajectory was firstly normalised for the real foot size and measured in software Kinovea to obtain the foot measures: Line A connect the initial point and final point of the COP trajectory, line B was drawn perpendicular to the line A in the widest part of the forefoot, line C was a partial section of the line B between crossing points with line A and COP trajectory. Final calculation of CPEI was done: Line C divided by line B multiplied 100 to obtain total percentage. According to previous studies (Hillstrom et al., 2013; Song et al., 1996), the sample results were divided into thirds: CPEI 10-24.9% for over-pronation, CPEI 25-34.9% for optimal function, and CPEI above 35% for supinated function.
Time Frame
at baseline and in 4 weeks
Title
Change from baseline Postural stability at 4 weeks
Description
The postural stability function in single-leg stance was measured on pressure platform RS Footscan (Balance 7.6). Participant stood up on the mat 1.5 m far from the wall, watching the point on the wall in the height of his eyes and flexed non-tested leg up to 90° with thigh still in vertical position. Participant was instructed to stand steadily without moving for 60 s with eyes open. After the rest, participant repeated the same measurement on the other side. Centre of pressure path (COPP) length in millimeters was obtained for both legs.
Time Frame
at baseline and in 4 weeks
Title
Core stabilization function
Description
The core stabilization function was assessed by clinical test according to protocol of dynamic neuromuscular stabilisation concept (Kolar et al., 2009) in developmental kinesiology position in supine with legs flexed and raised up and experienced physiotherapist observed the quality of the muscle coordination in stabilisation of the trunk and abdominal wall. The quality of the function was defined as these: 1) optimal function (not co-movements of the region, homogenous abdominal wall, harmonic activation aóf all local and global stabilisers), 2) weakened function (not homogenous abdominal wall, light lumbar movement up) and 3) dysfunction with diastasis (insufficiency of the deep abdominal muscle, over-activation m. rectus abdominis, lumbar spine above the ground, movement and instability of the whole region, diastasis).
Time Frame
at baseline

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: age 9-10 years playing football at least for one year and train twice a week FPI above 5 CSI above 45.1% Exclusion Criteria: acute pain, injury injury of musculoskeletal system (past 6 months) infectious disease cardiovascular, metabolic, neurologic or orthopaedic diseases active wearing the orthotic devices or aids or barefoot shoes previous surgery on the lower limbs or pelvis
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

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
It is planned that selected anonymised data will be published in open access research journal and other individual anonymised data just for the request.
IPD Sharing Time Frame
1 year from the public registration.
IPD Sharing Access Criteria
Researchers can apply for the anonymised dataset by the email to investigator, only for the reasoned request.

Learn more about this trial

Neurophysiology-based Intervention of Foot Dysfunction in Sportive Children

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