Clinical trial NCT05902091: Neurophysiology-based Intervention of Foot Dysfunction in Sportive Children
Official title: Neurophysiology-based Intervention Program in Sportive Children With Foot Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Flatfoot, Flexible
Sports Physical Therapy
Child Development
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 14
Sex: MALE
Minimum age (years): 9
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

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

Primary outcomes:
measure: Change from baseline Foot type at 4 weeks
timeFrame: at baseline and in 4 weeks
measure: Change from baseline Medial longitudinal arch height at 4 weeks
timeFrame: at baseline and in 4 weeks
measure: Change from baseline Foot dynamic function at 4 weeks
timeFrame: at baseline and in 4 weeks
measure: Change from baseline Postural stability at 4 weeks
timeFrame: at baseline and in 4 weeks
measure: Core stabilization function
timeFrame: at baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Faculty of Physical Education and Sport, Charles University
Study officials:
affiliation: Faculty of Physical Education and Sport, Charles University
name: František Zahálka, prof., Ph.D.
role: STUDY_DIRECTOR
affiliation: Faculty of Physical Eduction and Sport, Charles University
name: Jitka Marenčáková, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: