Sponsor study identifier
interventional
14
1 country
1
Study Start
June 10, 2016
Actual (reported)Primary Completion
September 5, 2017
Actual (reported)Study Completion
September 20, 2018
Actual (reported)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:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 20, 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 10, 2016
Actual (reported)September 5, 2017
Actual (reported)September 20, 2018
Actual (reported)May 23, 2023
Actual (reported)June 13, 2023
Actual (reported)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.
Participants will receive 4 weeks of neurophysiology-based intervention, forty-five minutes of individual session, twice a week.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Faculty of Physical Education and Sport, Charles University
Prague, Czechia
František Zahálka, prof., Ph.D.
Faculty of Physical Education and Sport, Charles University
Jitka Marenčáková, Ph.D.
Faculty of Physical Eduction and Sport, Charles University
14 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2023
First Posted
June 13, 2023
Study Start
June 10, 2016
Actual (reported)Early Literacy Promotion Intervention
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
Contact the study team to confirm eligibility.
Primary Completion
September 5, 2017
Actual (reported)Study Completion
September 20, 2018
Actual (reported)Last Updated
June 13, 2023
Record last verified: 2023-06
It is planned that selected anonymised data will be published in open access research journal and other individual anonymised data just for the request.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: