Neurophysiology-based Intervention of Foot Dysfunction in Sportive Children

NCT05902091 | Completed

• 1 other identifier: UKFTVS_LSM_02
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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:

1. 1.see if the medial longitudinal arch will by actively more higher after the intervention
2. 2.see if the type of the foot will change toward more neutral type after the intervention
3. 3.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

Conditions

Flatfoot, Flexible; Sports Physical Therapy; Child Development

Outcome Measures

Primary Outcomes (5)

• 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).

  at baseline and in 4 weeks

• 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).

  at baseline and in 4 weeks

• 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.

  at baseline and in 4 weeks

• 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.

  at baseline and in 4 weeks

• 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).

  at baseline

Study Arms (1)

Exercising participants

EXPERIMENTAL

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

Behavioral: Neurophysiology-based intervention

Interventions

Neurophysiology-based intervention BEHAVIORAL

Exercising participants

Eligibility Criteria

• Age: 9 Years - 10 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• age 9-10 years
• playing football at least for one year and train twice a week
• FPI above 5
• CSI above 45.1%

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (1)

Faculty of Physical Education and Sport, Charles University

Prague, Czechia

Location

MeSH Terms

Conditions

Flatfoot

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

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoc researcher

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 13, 2023
• Study Start: June 10, 2016
• Primary Completion: September 5, 2017
• Study Completion: September 20, 2018
• Last Updated: June 13, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year from the public registration.
• Access Criteria: Researchers can apply for the anonymised dataset by the email to investigator, only for the reasoned request.

Locations

CZ (1)