Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04840017
Other study ID # Gdansk UPES
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date January 15, 2021
Est. completion date December 15, 2026

Study information

Verified date August 2023
Source Gdansk University of Physical Education and Sport
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

"Idiopathic flat foot is a common condition in children and adolescents. After loading, the heel is adjusted in valgus, the medial longitudinal arch of the foot flattens, and the forefoot is positioned at abducted. Such deformation can be classified as flexible or rigid. A lowered flat foot arch is an undesirable feature. Additional factors such as e.g. abnormal body weight, may have impact on the shape of medial longitudinal arch. Increasing evidence suggests that excess weight is inextricably linked to flatfoot and postural stability. In connection with consequences, disorders of the muscles responsible for stabilizing the arches of the foot are noticed. The mobility and stability of the foot arches is controlled by the internal and external muscles of the foot, but the former are often overlooked in therapy. Short foot exercises are recommended as an improvement in foot arch parameters. The participants will take part in the research with the written consent of their parents or legal guardians. The results will be used anonymously for scientific publications."


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Other:
rehabilitation exercise
Rehabilitation exercise of intrinsic foot muscles

Locations

Country Name City State
Poland Gdansk University of Physical Education and Sport Gdansk

Sponsors (2)

Lead Sponsor Collaborator
Gdansk University of Physical Education and Sport Medical University of Gdansk

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Navicular Height (NH) The localization of the medial navicular tuberosity and its distance from the floor as NH will be done in a standing position. The result will be given in millimeters. Baseline
Primary Navicular Height (NH) The localization of the medial navicular tuberosity and its distance from the floor as NH will be done in a standing position. The result will be given in millimeters. 6-weeks intervention
Primary Navicular Height (NH) The localization of the medial navicular tuberosity and its distance from the floor as NH will be done in a standing position. The result will be given in millimeters. 3 months later
Primary Navicular Height (NH) The localization of the medial navicular tuberosity and its distance from the floor as NH will be done in a standing position. The result will be given in millimeters. 6 months later
Primary Body Mass Index (BMI) Each child's weight and height will be assessed to determine their BMI using the formula weight [kg] / height [m] 2.
This will be interpreted according to the international cut-off points. In addition, body composition will be analyzed using bioelectric impedance.
baseline
Primary Body Mass Index (BMI) Each child's weight and height will be assessed to determine their BMI using the formula weight [kg] / height [m] 2.
This will be interpreted according to the international cut-off points. In addition, body composition will be analyzed using bioelectric impedance.
6-weeks intervention
Primary Body Mass Index (BMI) Each child's weight and height will be assessed to determine their BMI using the formula weight [kg] / height [m] 2.
This will be interpreted according to the international cut-off points. In addition, body composition will be analyzed using bioelectric impedance.
3 months later
Primary Body Mass Index (BMI) Each child's weight and height will be assessed to determine their BMI using the formula weight [kg] / height [m] 2.
This will be interpreted according to the international cut-off points. In addition, body composition will be analyzed using bioelectric impedance.
6 months later
Secondary Foot Posture Index-6 (FPI-6) The FPI-6 scale consists of 6 separate grades that are then summarized to give a score that reflects foot position. The scale makes it possible to analyze the entire FPI-6 result, as well as to consider the results for individual components. Each of the six parts of FPI-6 is rated on a scale of -2 to +2. The neutral position of the foot is classified as 0, during which pronation becomes positive and supination negative. Baseline
Secondary Foot Posture Index-6 (FPI-6) The FPI-6 scale consists of 6 separate grades that are then summarized to give a score that reflects foot position. The scale makes it possible to analyze the entire FPI-6 result, as well as to consider the results for individual components. Each of the six parts of FPI-6 is rated on a scale of -2 to +2. The neutral position of the foot is classified as 0, during which pronation becom 6-weeks intervention
Secondary Foot Posture Index-6 (FPI-6) The FPI-6 scale consists of 6 separate grades that are then summarized to give a score that reflects foot position. The scale makes it possible to analyze the entire FPI-6 result, as well as to consider the results for individual components. Each of the six parts of FPI-6 is rated on a scale of -2 to +2. The neutral position of the foot is classified as 0, during which pronation becomes positive and supination negative 3 months later
Secondary Foot Posture Index-6 (FPI-6) The FPI-6 scale consists of 6 separate grades that are then summarized to give a score that reflects foot position. The scale makes it possible to analyze the entire FPI-6 result, as well as to consider the results for individual components. Each of the six parts of FPI-6 is rated on a scale of -2 to +2. The neutral position of the foot is classified as 0, during which pronation becomes positive and supination negative. 6 months later
Secondary Arch Index (AI) The AI will be calculated from a footprint, which clearly defines the weightbearing area of the foot. The footprint will be marked with a "foot axis" line from the centre of the heel to the second toe. The foot axis line will be then separated into 3 equal sections with the separated areas defined as A (forefoot), B (midfoot), and C (rearfoot). This process follows that reported by Cavanagh and Rodgers. The Arch Index (AI) will be obtained from the formula B/A+B+C with the weightbearing area of the toes excluded from the calculation of the AI ratio. baseline
Secondary Arch Index (AI) The AI will be calculated from a footprint, which clearly defines the weightbearing area of the foot. The footprint will be marked with a "foot axis" line from the centre of the heel to the second toe. The foot axis line will be then separated into 3 equal sections with the separated areas defined as A (forefoot), B (midfoot), and C (rearfoot). This process follows that reported by Cavanagh and Rodgers. The Arch Index (AI) will be obtained from the formula B/A+B+C with the weightbearing area of the toes excluded from the calculation of the AI ratio. 6-weeks intervention
Secondary Arch Index (AI) The AI will be calculated from a footprint, which clearly defines the weightbearing area of the foot. The footprint will be marked with a "foot axis" line from the centre of the heel to the second toe. The foot axis line will be then separated into 3 equal sections with the separated areas defined as A (forefoot), B (midfoot), and C (rearfoot). This process follows that reported by Cavanagh and Rodgers. The Arch Index (AI) will be obtained from the formula B/A+B+C with the weightbearing area of the toes excluded from the calculation of the AI ratio. 3 months later
Secondary Arch Index (AI) The AI will be calculated from a footprint, which clearly defines the weightbearing area of the foot. The footprint will be marked with a "foot axis" line from the centre of the heel to the second toe. The foot axis line will be then separated into 3 equal sections with the separated areas defined as A (forefoot), B (midfoot), and C (rearfoot). This process follows that reported by Cavanagh and Rodgers. The Arch Index (AI) will be obtained from the formula B/A+B+C with the weightbearing area of the toes excluded from the calculation of the AI ratio. 6 months later
Secondary VICON "Vicon Nexus gait analysis system with 10 Cameras MX-T20 and with three AMTI platforms sampled at 1000 Hz will be used to capture foot kinematics during barefoot walking and self-selected speed along 14m walkway. Markers will be placed according to the Oxford Foot Model (OFM) and the Lower body Plug-in gait Model (PIG) sampled at 200 Hz.
The data will be repeated until 5 clean completed passes. The Data will then be imported into Poligon 3D motion of the hindfoot to tibia, forefoot to hindfoot, as well as hallux to forefoot and the arch height will be extracted according to the OFM . For each foot, kinematic and kinetic traces will be checked visually and inconsistent trials will be removed."
baseline
Secondary VICON "Vicon Nexus gait analysis system with 10 Cameras MX-T20 and with three AMTI platforms sampled at 1000 Hz will be used to capture foot kinematics during barefoot walking and self-selected speed along 14m walkway. Markers will be placed according to the Oxford Foot Model (OFM) and the Lower body Plug-in gait Model (PIG) sampled at 200 Hz.
The data will be repeated until 5 clean completed passes. The Data will then be imported into Poligon 3D motion of the hindfoot to tibia, forefoot to hindfoot, as well as hallux to forefoot and the arch height will be extracted according to the OFM . For each foot, kinematic and kinetic traces will be checked visually and inconsistent trials will be removed."
6-weeks intervention
Secondary VICON "Vicon Nexus gait analysis system with 10 Cameras MX-T20 and with three AMTI platforms sampled at 1000 Hz will be used to capture foot kinematics during barefoot walking and self-selected speed along 14m walkway. Markers will be placed according to the Oxford Foot Model (OFM) and the Lower body Plug-in gait Model (PIG) sampled at 200 Hz.
The data will be repeated until 5 clean completed passes. The Data will then be imported into Poligon 3D motion of the hindfoot to tibia, forefoot to hindfoot, as well as hallux to forefoot and the arch height will be extracted according to the OFM . For each foot, kinematic and kinetic traces will be checked visually and inconsistent trials will be removed."
3 months later
Secondary VICON "Vicon Nexus gait analysis system with 10 Cameras MX-T20 and with three AMTI platforms sampled at 1000 Hz will be used to capture foot kinematics during barefoot walking and self-selected speed along 14m walkway. Markers will be placed according to the Oxford Foot Model (OFM) and the Lower body Plug-in gait Model (PIG) sampled at 200 Hz.
The data will be repeated until 5 clean completed passes. The Data will then be imported into Poligon 3D motion of the hindfoot to tibia, forefoot to hindfoot, as well as hallux to forefoot and the arch height will be extracted according to the OFM . For each foot, kinematic and kinetic traces will be checked visually and inconsistent trials will be removed."
6 months later
Secondary BIODEX Biodex Balance System SD 115VAC will be used as equipment for testing static and dynamic stability. Dynamic posture assessment will be performed on the unstable platform using the test on level 5 and 12 to 8 (12 as the most stable platform, 1 the least). Familiarization with the test procedure will be performed prior to the test. The patient's data: age, height and the position of feet in relation to the third metatarsal bone as well as the heel position will be entered into the platform. Three indicators will be obtained: AP - anterior/posterior, ML - medial/lateral and OSI - overall stability index. During the evaluation each child will be asked to stand in the centre of the platform bare feet with arms along the body, looking straight ahead, focusing on the visual feedback screen. For each level of the dynamic stability measurement three trials will be performed and the average will be calculated. Children will be tested in two conditions: with eyes open and closed. baseline
Secondary BIODEX Biodex Balance System SD 115VAC will be used as equipment for testing static and dynamic stability. Dynamic posture assessment will be performed on the unstable platform using the test on level 5 and 12 to 8 (12 as the most stable platform, 1 the least). Familiarization with the test procedure will be performed prior to the test. The patient's data: age, height and the position of feet in relation to the third metatarsal bone as well as the heel position will be entered into the platform. Three indicators will be obtained: AP - anterior/posterior, ML - medial/lateral and OSI - overall stability index. During the evaluation each child will be asked to stand in the centre of the platform bare feet with arms along the body, looking straight ahead, focusing on the visual feedback screen. For each level of the dynamic stability measurement three trials will be performed and the average will be calculated. Children will be tested in two conditions: with eyes open and closed. 6-weeks intervention
Secondary BIODEX Biodex Balance System SD 115VAC will be used as equipment for testing static and dynamic stability. Dynamic posture assessment will be performed on the unstable platform using the test on level 5 and 12 to 8 (12 as the most stable platform, 1 the least). Familiarization with the test procedure will be performed prior to the test. The patient's data: age, height and the position of feet in relation to the third metatarsal bone as well as the heel position will be entered into the platform. Three indicators will be obtained: AP - anterior/posterior, ML - medial/lateral and OSI - overall stability index. During the evaluation each child will be asked to stand in the centre of the platform bare feet with arms along the body, looking straight ahead, focusing on the visual feedback screen. For each level of the dynamic stability measurement three trials will be performed and the average will be calculated. Children will be tested in two conditions: with eyes open and closed. 3 months later
Secondary BIODEX Biodex Balance System SD 115VAC will be used as equipment for testing static and dynamic stability. Dynamic posture assessment will be performed on the unstable platform using the test on level 5 and 12 to 8 (12 as the most stable platform, 1 the least). Familiarization with the test procedure will be performed prior to the test. The patient's data: age, height and the position of feet in relation to the third metatarsal bone as well as the heel position will be entered into the platform. Three indicators will be obtained: AP - anterior/posterior, ML - medial/lateral and OSI - overall stability index. During the evaluation each child will be asked to stand in the centre of the platform bare feet with arms along the body, looking straight ahead, focusing on the visual feedback screen. For each level of the dynamic stability measurement three trials will be performed and the average will be calculated. Children will be tested in two conditions: with eyes open and closed. 6 months later
Secondary Y-BALANCE TEST The children will be acquainted with the methodology of the test and testing procedures. Prior to formal testing children will practise 6 trials on each leg in 3 reach directions. The children will perform one leg stand in the centre of the grid, with the most distal aspect of the great toe at the starting line. While maintaining a single-leg stance, the children will be asked to reach the anterior, posteromedial and posterolateral directions with the lifted limb. The whole process will be repeated while standing on the other leg. The maximal reaching point will be considered for the future analysis. The trial will be discarded and repeated if the children (1) fail to maintain unilateral stance, (2) lift or move the stance foot from the grid, (3) touch down with the reach foot, or (4) fail to return the reach foot to the starting position. Three proper trials in each reach direction will be used for analysis. baseline
Secondary Y-BALANCE TEST The children will be acquainted with the methodology of the test and testing procedures. Prior to formal testing children will practise 6 trials on each leg in 3 reach directions. The children will perform one leg stand in the centre of the grid, with the most distal aspect of the great toe at the starting line. While maintaining a single-leg stance, the children will be asked to reach the anterior, posteromedial and posterolateral directions with the lifted limb. The whole process will be repeated while standing on the other leg. The maximal reaching point will be considered for the future analysis. The trial will be discarded and repeated if the children (1) fail to maintain unilateral stance, (2) lift or move the stance foot from the grid, (3) touch down with the reach foot, or (4) fail to return the reach foot to the starting position. Three proper trials in each reach direction will be used for analysis. 6-weeks intervention
Secondary Y-BALANCE TEST The children will be acquainted with the methodology of the test and testing procedures. Prior to formal testing children will practise 6 trials on each leg in 3 reach directions. The children will perform one leg stand in the centre of the grid, with the most distal aspect of the great toe at the starting line. While maintaining a single-leg stance, the children will be asked to reach the anterior, posteromedial and posterolateral directions with the lifted limb. The whole process will be repeated while standing on the other leg. The maximal reaching point will be considered for the future analysis. The trial will be discarded and repeated if the children (1) fail to maintain unilateral stance, (2) lift or move the stance foot from the grid, (3) touch down with the reach foot, or (4) fail to return the reach foot to the starting position. Three proper trials in each reach direction will be used for analysis. 3 months later
Secondary Y-BALANCE TEST The children will be acquainted with the methodology of the test and testing procedures. Prior to formal testing children will practise 6 trials on each leg in 3 reach directions. The children will perform one leg stand in the centre of the grid, with the most distal aspect of the great toe at the starting line. While maintaining a single-leg stance, the children will be asked to reach the anterior, posteromedial and posterolateral directions with the lifted limb. The whole process will be repeated while standing on the other leg. The maximal reaching point will be considered for the future analysis. The trial will be discarded and repeated if the children (1) fail to maintain unilateral stance, (2) lift or move the stance foot from the grid, (3) touch down with the reach foot, or (4) fail to return the reach foot to the starting position. Three proper trials in each reach direction will be used for analysis. 6 months later
Secondary sEMG "A sixteen-channel sEMG system will be used to recorded muscle activation. The sEMG and acceleration data will be transmitted to computer where the analogue data will be sampled at 2000Hz and stored for analysis.
The tibialis anterior, peroneus longus, medial and lateral gastrocnemius, abductor hallucis longus sEMG will be recorded with the use of surface electrodes. The application of the surface electrodes will be performed following the SENIAM's recommendations, additional abductor hallucis longus muscle, the sEMG electrodes will be placed approximately 1-2 cm posterior to the navicular tuberosity. The skin at the electrode sites will be properly prepared.
The sEMG data will be collected in coordination with Vicon data."
baseline
Secondary sEMG "A sixteen-channel sEMG system will be used to recorded muscle activation. The sEMG and acceleration data will be transmitted to computer where the analogue data will be sampled at 2000Hz and stored for analysis.
The tibialis anterior, peroneus longus, medial and lateral gastrocnemius, abductor hallucis longus sEMG will be recorded with the use of surface electrodes. The application of the surface electrodes will be performed following the SENIAM's recommendations, additional abductor hallucis longus muscle, the sEMG electrodes will be placed approximately 1-2 cm posterior to the navicular tuberosity. The skin at the electrode sites will be properly prepared.
The sEMG data will be collected in coordination with Vicon data."
6-weeks intervention
Secondary sEMG "A sixteen-channel sEMG system will be used to recorded muscle activation. The sEMG and acceleration data will be transmitted to computer where the analogue data will be sampled at 2000Hz and stored for analysis.
The tibialis anterior, peroneus longus, medial and lateral gastrocnemius, abductor hallucis longus sEMG will be recorded with the use of surface electrodes. The application of the surface electrodes will be performed following the SENIAM's recommendations, additional abductor hallucis longus muscle, the sEMG electrodes will be placed approximately 1-2 cm posterior to the navicular tuberosity. The skin at the electrode sites will be properly prepared.
The sEMG data will be collected in coordination with Vicon data."
3 months later
Secondary sEMG "A sixteen-channel sEMG system will be used to recorded muscle activation. The sEMG and acceleration data will be transmitted to computer where the analogue data will be sampled at 2000Hz and stored for analysis.
The tibialis anterior, peroneus longus, medial and lateral gastrocnemius, abductor hallucis longus sEMG will be recorded with the use of surface electrodes. The application of the surface electrodes will be performed following the SENIAM's recommendations, additional abductor hallucis longus muscle, the sEMG electrodes will be placed approximately 1-2 cm posterior to the navicular tuberosity. The skin at the electrode sites will be properly prepared.
The sEMG data will be collected in coordination with Vicon data."
6 months later
See also
  Status Clinical Trial Phase
Terminated NCT00527748 - Foot and Ankle Range of Motion (Stretching) Apparatus N/A
Completed NCT05128526 - Short Foot Exercises With Respiratuar Exercises N/A
Active, not recruiting NCT01645267 - Calcaneal Neck Lengthening Osteotomy With Artificial Bone Graft N/A
Completed NCT02957812 - The Effects of 12-week Custom-made Orthotic Intervention on the Structure and Function of the Foot of Healthy Young Adults During Gait Termination N/A
Recruiting NCT05018130 - Bio-Integrative Versus Metallic Screws for Calcaneus Osteotomies N/A
Completed NCT05875415 - Dynamic Plantar Pressures Changes After Dry Needling in Flexor Digitorum Brevis Versus Non Emission Laser N/A
Completed NCT05873166 - Stabilometry After Pressure Release of the Flexor Digitorum Brevis Muscle Versus a Non-emission Laser: Clinical Trial N/A
Recruiting NCT06296524 - Effect of Footcore Exercises on Navicular Drop and Plantar Pressure Distribution in Asymptomatic Individual With Flatfoot N/A
Recruiting NCT04564430 - Clonidine for Tourniquet-related Pain in Children Phase 4
Completed NCT03372642 - Effectiveness of Subtalar Arthroereisis With Endorthesis for Pediatric Flexible Flat Foot N/A
Not yet recruiting NCT05899855 - Foot Positions Affect Knee and Ankle Proprioception, Balance, Vertical Jump, and Muscle Activity in Individuals With Flexible and Rigid Flatfoot and Chronic Ankle Instability
Completed NCT02706327 - Comparison of Two Different Insole Types in Painful Flexible Flatfoot N/A
Completed NCT04003870 - Orthotics and Achilles Load in Runners N/A
Completed NCT05616637 - Investigation of Inter-rater and Test-retest Reliability of Y Balance Test in Individuals With Pes Planus
Completed NCT01187693 - The Outcome Effect of Shoe Lift for Individuals With Low Back Pain and Pronated Foot Due to Anatomical Leg Length Discrepancy N/A
Recruiting NCT05381558 - Evaluation of the Role of Local Steroid Injection in Treatment of Idiopathic Spasmodic Flat Foot in Adolescent Patients N/A
Completed NCT05437042 - Effect of Medial Wedge on Static Balance in Pronated Feet