FlatfootNCT04840017
The Influence of Rehabilitation Program on Postural Control, Balance and Gait in Children With Flatfoot
A study testing rehabilitation exercise in people with Flatfoot, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Flatfoot
- What is being tested?
- rehabilitation exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 sitePoland
- Study dates
- 15 Jan 2021to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Bilateral flexible flatfeet
Who cannot join
- Tarsal coalitions,
- Congenital defects of the lower limbs,
- Neurological diseases,
- Previous foot surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Influence of Rehabilitation Program on Postural Control, Balance and Basic Gait Parameters on the Formation of the Foot's Longitudinal Arch in Children With Flatfoot and Excessive Body Mass
"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.
Read more
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."
Read the detailed description
"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. The importance of shaping the longitudinal arch of the foot is one of the most controversial issues in orthopedics. A lowered flat foot arch is an undesirable feature.
The shape of the arch is determined by age and genetic conditions. The age of six is believed to be a critical moment for the development of the medial longitudinal arch, since it is the age when the development of the medial longitudinal foot arch slows down to finally stop at the age of 12-13. Therefore, it seems important to pay attention to the development of the medial longitudinal arch before adolescence in order to reduce the risk of perpetuating anomalies.
Incorrect arching can cause changes in the ankle, and pronative positioning of the foot influences the adjacent joints of the lower limb and the spine, which results in impaired control of body posture, kinetics and gait kinematics. The pain induced by the changes in body functioning increases the risk of injury.
The foot is the most distal segment of the lower limb bio-kinematic chain and represents a relatively small support base while maintaining balance. Even very small changes in this segment may be the reason of disturbances in posture control strategy. In addition, elimination of longitudinal arch of the foot and hypermobile metatarsus can be a challenge for neuromuscular system in terms of stabilization and maintenance of an upright posture. When medial longitudinal arch of the foot lowers it causes functional and consequently structural disturbances. Subsequently the ability to absorb impacts decreases and the feeling of balance can be lost leading to reduced stability
There are two reasons for the adverse effects of flat foot during gait:
- Flat feet have a shortened lever arm compared to those with correct arches. Shortening lever arm is caused by abducted forefoot in the transverse plane, hindfoot valgus and metatarsal disturbances in the sagittal plane;
- The lever (foot) becomes more elastic due to disturbances in the metatarsal and lowering of longitudinal arch in the sagittal plane. Because of loss of an appropriate degree of lever stiffness, the energy produced by the muscles in the push-off phase is not properly used.
Additional factors such as e.g. abnormal body weight, may have impact on the shape of medial longitudinal arch. The belief that overweight or obese children have flatter feet is based on research findings and may seem like an intuitive observation. Increasing evidence suggests that excess weight is inextricably linked to flatfoot and postural stability. Excessive body weight leads to a greater overall load, with a disproportionate effect on the midfoot area and the medial longitudinal arch. Childhood overweight and obesity are not compensated by the musculoskeletal system. Weight gain imposes additional biomechanical restrictions. Evans and coauthors demonstrated the existence of a correlation between the formation of the foot arch and body weight. According to Shiang and coauthors, flat feet of obese children may be the result of a decrease in the medial longitudinal arch due to overload, which is the result of overweight. Another consequence of abnormal weight can be balance disorders. Deforche et al. proved that overweight boys show reduced ability to perform tasks requiring static and dynamic balance. Comparative studies conducted using the Y Balance Test show differences in the range of forward movement of the lower limb, to the detriment of children with abnormal body weight, which is confirmed by studies on the correlation between postural stability and excessive body weight. In connection with the above-mentioned consequences, disorders of the muscles responsible for stabilizing the arches of the foot are noticed. Similar observations were made by Sung and coauthors and Murley and coauthors showing neuromuscular compensation associated with overloading medial longitudinal arch.
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. The possibility of isolated internal muscle tension of the foot is provided by ""short foot exercises"". Internal foot muscle training can improve foot function. Four-week training in adults with reduced foot arches, assessed by measuring the height of the navicular bone tuberosity and arch height index, improved balance. The results of the foot maneuver shortening test on children show that it is an effective method for increasing the arch and results in an improvement in the arch index. Short foot exercises are recommended as an improvement in foot arch parameters. Based on a meta-analysis carried out by Evans in 2008, it is believed that in the treatment of asymptomatic corrective flat feet and in disorders of their development in relation to the child's age, conservative treatment should be applied, including exercises to strengthen the intrinsic muscles of the feet. 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.
Hypothests: A six-week rehabilitation program for children with flat feet and excessive body weight will significantly affect the formation of the medial longitudinal arch, basic gait parameters and balance."
- Conditions
- Flatfoot
- Being tested
- rehabilitation exercise
- Keywords
- Planovalgus, Medial Longitudinal Arch, Gait, Kinematic, Emg, Walk, Locomotion, Motion Analysis, Low-arched Feet, Valgus Deformity, Balance
- Medical subject headings
- Flatfoot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation exerciseOther
Rehabilitation exercise of intrinsic foot muscles
| Study group | Role | What they receive |
|---|---|---|
| Study group I | Experimental | excessive body weight and flat feet Receives: Other: rehabilitation exercise |
| Study group II | Experimental | normal body weight and flat feet Receives: Other: rehabilitation exercise |
| Study group III | No intervention | control, healthy children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
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.
Measured: 6-weeks intervention
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.
Measured: 3 months later
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.
Measured: 6 months later
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.
Measured: baseline
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.
Measured: 6-weeks intervention
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.
Measured: 3 months later
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.
Measured: 6 months later
Secondary outcomes (24)
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.
Measured: Baseline
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
Measured: 6-weeks intervention
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
Measured: 3 months later
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.
Measured: 6 months later
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.
Measured: baseline
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.
Measured: 6-weeks intervention
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.
Measured: 3 months later
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.
Measured: 6 months later
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."
Measured: baseline
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."
Measured: 6-weeks intervention
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."
Measured: 3 months later
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."
Measured: 6 months later
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.
Measured: baseline
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.
Measured: 6-weeks intervention
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.
Measured: 3 months later
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.
Measured: 6 months later
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.
Measured: baseline
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.
Measured: 6-weeks intervention
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.
Measured: 3 months later
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.
Measured: 6 months later
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."
Measured: baseline
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."
Measured: 6-weeks intervention
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."
Measured: 3 months later
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."
Measured: 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start15 Jan 2021
- Primary completion29 Apr 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlatfootStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Gdansk
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840017
- Sponsor's protocol ID
- Gdansk UPES
- Status last verified
- Aug 2023
- First submitted
- 3 Feb 2021
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Rehabilitation Program on Postural Control, Balance and Basic Gait Parameters on the Formation of the Foot's Longitudinal Arch in Children With Flatfoot and Excessive Body Mass
- ClinicalTrials.gov ID
- NCT04840017
- Acronym / sponsor ID
- Gdansk UPES
- Conditions
- Flatfoot
- Keywords
- Planovalgus, Medial Longitudinal Arch, Gait, Kinematic, Emg, Walk, Locomotion, Motion Analysis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Collaborators
- Medical University of Gdansk
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 29 Apr 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 9 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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."
Detailed description
"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. The importance of shaping the longitudinal arch of the foot is one of the most controversial issues in orthopedics. A lowered flat foot arch is an undesirable feature.
The shape of the arch is determined by age and genetic conditions. The age of six is believed to be a critical moment for the development of the medial longitudinal arch, since it is the age when the development of the medial longitudinal foot arch slows down to finally stop at the age of 12-13. Therefore, it seems important to pay attention to the development of the medial longitudinal arch before adolescence in order to reduce the risk of perpetuating anomalies.
Incorrect arching can cause changes in the ankle, and pronative positioning of the foot influences the adjacent joints of the lower limb and the spine, which results in impaired control of body posture, kinetics and gait kinematics. The pain induced by the changes in body functioning increases the risk of injury.
The foot is the most distal segment of the lower limb bio-kinematic chain and represents a relatively small support base while maintaining balance. Even very small changes in this segment may be the reason of disturbances in posture control strategy. In addition, elimination of longitudinal arch of the foot and hypermobile metatarsus can be a challenge for neuromuscular system in terms of stabilization and maintenance of an upright posture. When medial longitudinal arch of the foot lowers it causes functional and consequently structural disturbances. Subsequently the ability to absorb impacts decreases and the feeling of balance can be lost leading to reduced stability
There are two reasons for the adverse effects of flat foot during gait:
- Flat feet have a shortened lever arm compared to those with correct arches. Shortening lever arm is caused by abducted forefoot in the transverse plane, hindfoot valgus and metatarsal disturbances in the sagittal plane;
- The lever (foot) becomes more elastic due to disturbances in the metatarsal and lowering of longitudinal arch in the sagittal plane. Because of loss of an appropriate degree of lever stiffness, the energy produced by the muscles in the push-off phase is not properly used.
Additional factors such as e.g. abnormal body weight, may have impact on the shape of medial longitudinal arch. The belief that overweight or obese children have flatter feet is based on research findings and may seem like an intuitive observation. Increasing evidence suggests that excess weight is inextricably linked to flatfoot and postural stability. Excessive body weight leads to a greater overall load, with a disproportionate effect on the midfoot area and the medial longitudinal arch. Childhood overweight and obesity are not compensated by the musculoskeletal system. Weight gain imposes additional biomechanical restrictions. Evans and coauthors demonstrated the existence of a correlation between the formation of the foot arch and body weight. According to Shiang and coauthors, flat feet of obese children may be the result of a decrease in the medial longitudinal arch due to overload, which is the result of overweight. Another consequence of abnormal weight can be balance disorders. Deforche et al. proved that overweight boys show reduced ability to perform tasks requiring static and dynamic balance. Comparative studies conducted using the Y Balance Test show differences in the range of forward movement of the lower limb, to the detriment of children with abnormal body weight, which is confirmed by studies on the correlation between postural stability and excessive body weight. In connection with the above-mentioned consequences, disorders of the muscles responsible for stabilizing the arches of the foot are noticed. Similar observations were made by Sung and coauthors and Murley and coauthors showing neuromuscular compensation associated with overloading medial longitudinal arch.
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. The possibility of isolated internal muscle tension of the foot is provided by ""short foot exercises"". Internal foot muscle training can improve foot function. Four-week training in adults with reduced foot arches, assessed by measuring the height of the navicular bone tuberosity and arch height index, improved balance. The results of the foot maneuver shortening test on children show that it is an effective method for increasing the arch and results in an improvement in the arch index. Short foot exercises are recommended as an improvement in foot arch parameters. Based on a meta-analysis carried out by Evans in 2008, it is believed that in the treatment of asymptomatic corrective flat feet and in disorders of their development in relation to the child's age, conservative treatment should be applied, including exercises to strengthen the intrinsic muscles of the feet. 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.
Hypothests: A six-week rehabilitation program for children with flat feet and excessive body weight will significantly affect the formation of the medial longitudinal arch, basic gait parameters and balance."
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group I | Experimental | Other: rehabilitation exerciseexcessive body weight and flat feet |
| Study group II | Experimental | Other: rehabilitation exercisenormal body weight and flat feet |
| Study group III | No intervention | –control, healthy children |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Bilateral flexible flatfeet
Key exclusion criteria (4 listed)
- Tarsal coalitions,
- Congenital defects of the lower limbs,
- Neurological diseases,
- Previous foot surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rehabilitation exerciseRehabilitation exercise of intrinsic foot muscles | Other | Study group I, Study group II |
Primary outcome
Navicular Height (NH)
Time frame: Baseline
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.
Navicular Height (NH)
Time frame: 6-weeks intervention
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.
Navicular Height (NH)
Time frame: 3 months later
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.
Navicular Height (NH)
Time frame: 6 months later
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.
Body Mass Index (BMI)
Time frame: baseline
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.
Body Mass Index (BMI)
Time frame: 6-weeks intervention
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.
Body Mass Index (BMI)
Time frame: 3 months later
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.
Body Mass Index (BMI)
Time frame: 6 months later
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.
24 secondary outcomes
Foot Posture Index-6 (FPI-6)
Time frame: Baseline
Foot Posture Index-6 (FPI-6)
Time frame: 6-weeks intervention
Foot Posture Index-6 (FPI-6)
Time frame: 3 months later
Foot Posture Index-6 (FPI-6)
Time frame: 6 months later
Arch Index (AI)
Time frame: baseline
Arch Index (AI)
Time frame: 6-weeks intervention
Arch Index (AI)
Time frame: 3 months later
Arch Index (AI)
Time frame: 6 months later
VICON
Time frame: baseline
VICON
Time frame: 6-weeks intervention
VICON
Time frame: 3 months later
VICON
Time frame: 6 months later
BIODEX
Time frame: baseline
BIODEX
Time frame: 6-weeks intervention
BIODEX
Time frame: 3 months later
BIODEX
Time frame: 6 months later
Y-BALANCE TEST
Time frame: baseline
Y-BALANCE TEST
Time frame: 6-weeks intervention
Y-BALANCE TEST
Time frame: 3 months later
Y-BALANCE TEST
Time frame: 6 months later
sEMG
Time frame: baseline
sEMG
Time frame: 6-weeks intervention
sEMG
Time frame: 3 months later
sEMG
Time frame: 6 months later
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
Related trials for Flatfoot
Recruiting
Effects of Custom 3D Printed Insoles and Short Foot Exercises in Pes Planus
Pes Planus
Not yet recruiting
Correlation Between Soft Tissue Displacement and Functional Performance in Orthopedic Patients
Hamstring Muscle Strain, Adult Acquired Flatfoot Deformity
Not yet recruiting
The Corrective Power of Subtalar Arthrodesis With Mini/Medial Bone Block (SAMBB) in Patients Affected by Progressive Collapsing Foot Deformity (PCFD): Analysis Using Weight-bearing Cone Beam CT.
Flat Foot
Not yet recruitingObservational study
Tibialis Posterior Muscle Morphology in Flexible Flatfeet Subjects
Flexible Flatfoot
Recruiting
Plantar Stimulation, Whole-Body Vibration, and Baduanjin for Muscle Activation
Flat Feet, Lower-Limb Muscle Activation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation exercise in people with Flatfoot, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Navicular Height (NH) (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.