Efficacy of Personalized Foot Orthoses in Children with Flexible Flat Foot: Protocol for a Randomized Controlled Trial
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Setting
2.2. Eligibility Criteria
2.3. Interventions
2.3.1. Group 1
2.3.2. Group 2
2.4. Outcomes Measures
2.4.1. Qualitative or Categorical Variables:
- Gender: masculine or feminine.
- Pain: symptomatic or asymptomatic.
- Level of physical activity: high-low-nil.
- Double/simple heel rise test: Standing on toes with two legs/one leg for 25 repetitions. It will be considered positive if the participant is incapable due to fatigue or if when raising the calcaneus does not present a varus position [38].
- Supination resistance test: high-moderate-low. The patient is instructed to stand relaxed without any attempt to move the foot or lift the arch. The examiner’s fingertips are then placed plantar to the medial half of the navicular, and the examiner exerts a significant lifting force on the navicular. A normal foot will demonstrate subtalar joint supination with minimal lifting force. A pes valgus deformity will need extreme amounts of lifting force in order to produce little, if any, subtalar joint supination motion [40].
- Subtalar joint axis: Lateralized-neutral-medialized. The center of the neck of the talus should be located and marked to see the lateralized or medialized point, or if, on the contrary, it stops at the 2nd finger, which would indicate that it is neutral [36].
- Shoe wear at heel level: medial-center-lateral.
- Maximum pronation test: Positive or negative. The patient is asked to try pronate as much as possible; it is considered positive when performing the maneuver, the calcaneus cannot pronate more than 2° [41].
- Forefoot: adduction-neutral-abduction position [36].
- Foot posture index (FPI): Normal = 0 to +5; pronated = +6 to +9; highly Pronated = +10 to +12; supinated = −1 to −4 and highly supinated = −5 to −12. The six clinical criteria assessed: 1. palpation of the talus head; 2. lateral supra and inframalleolar curvature; 3. position of the calcaneus in the frontal plane; 4. prominence of the talonavicular region; 5. congruence of the internal longitudinal arch and 6. abduction/adduction of the forefoot with respect to the rearfoot. As we observe them, the following score is given: neutral = 0; clear signs of supination = −2; clear signs of pronation = +2 [33].
- Test of windlass: Positive or negative. It will be considered positive if, when performing dorsiflexion of the hallux, there is not supination of the foot, plantarflexion of the 1st ray, increase in the MLA and internal rotation of the tibia [39].
- Beighton scale: Hypermobility or normal. Subjects are rated on a 9-point scale, considering 1 point for each hypermobile site. These 9 points are: 1-hyperextension of the elbows (more than 10°), 2-passively touch the forearm with the thumb, having the wrist in flexion, 3-passive extension of the index finger to more than 90°, with the palm of the hand resting on the bed, 4-hyperextension of the knees (10° or more), patient in supine position and 5-flexion of the trunk forward touching the ground with the palms of the hands by bending without bending your knees. To be considered as hypermobile, it is required to have 4 points or more of the total of 9 [42].
- Podoscope: pronated-supinated-neutral [36].
- Pressure platform: maximum pressure zone, location of the center of gravity, gait progression line [43].
2.4.2. Quantitative or Numerical Variables
- Age: in months.
- Weight: in Kg.
- Height: in meters.
- Body Mass Index (BMI): Will be calculated with the formula weight (Kg) divided by height squared (meters2). The classification of each child in low weight, normal weight, overweight or obesity will depend on the child’s sex, height, weight and age [44].
- Pain: visual analog scale (from 1 to 10, 1 being minimum pain and 10 maximum pain).
- FPI: The six clinical criteria used in PFI are: 1. palpation of the talus head; 2. curvature supra and lateral inframaleolar region; 3. position of the calcaneus in the frontal plane; 4. prominence of the talonavicular region; 5. congruence of the internal longitudinal arch and 6. abduction/adduction of the forefoot with respect to the rearfoot. (Score: neutral = 0; clear signs of supination = −2; clear signs of pronation = +2) [33].
- RCSP: degrees of calcaneal eversion. The valgus degrees of the calcaneus are measured in bipedal support [35].
- Navicular drop: in millimeters. It measures the difference between the navicular position when the patient’s foot is in a neutral position and when the patient’s foot is in its normal position. It measures how many millimeters the medial tuberosity of the scaphoid has descended [34].
- Pronation angle: in degrees. To calculate the bisection of the distal third of the tibia with respect to the bisection of the calcaneus [36].
- Chippaux-Smirak index: in cm. On the footprint of the subject taken from a pedigraphy, the narrowest distance from the medial part of the foot (B) with the widest distance from the forefoot (A) must be measured. It is divided B/A [45].
- Pressure platform: percentage of load/weight on each foot and distribution of the same (anterior load, posterior load, load of the left and right foot) [43].
- Arch index: numerical scale. The patient’s footprint is taken with a pedigraphy, the toe area is excluded and a longitudinal line is drawn that goes from the center of the heel to the 2nd toe. A line is then drawn perpendicular to the 1st. Two lines are drawn perpendicular to this axis to see the anterior extent of the forefoot area. The axis of the foot is divided into 3 equal parts and here 3 zones are defined: A: forefoot, B: midfoot and C: rearfoot. The arch index is calculated: B/(A + B + C) [37].
- Foot size: in cm.
- Silfverskiold test: in degrees. The degrees of dorsiflexion of the ankle (starting from a position of 90°) with extended knee and bent knee [46] will be measured.
- Navicular height: in millimeters. Measure the height of the scaphoid to the ground with the subject sitting [47].
2.5. Blinding and Monitoring
2.6. Sample Size
2.7. Statistical Analysis
2.8. Ethics and Dissemination
3. Expected Results
3.1. Limitations
3.2. Strengths
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Appendix A. Planned Schedule for the Study
2023 | 2024 | 2025 | ||||||||
Time/Activities | August | September | October | November | December | Full year | January | February | March | April |
Project development and patient recruitment | X | |||||||||
Data collection and initiation of processing | X | |||||||||
Prospective follow-up | X | X | X | X | X | X | ||||
Data analysis | X | |||||||||
Results and conclusions | X | X | ||||||||
Preparation of the document | X |
Appendix B. Informed Consent and Patient Information Model
- -
- I have read the Information Sheet that has been given to me.
- -
- I have asked all the questions I considered necessary about the study.
- -
- I have received satisfactory answers to all my questions.
- -
- I have received enough information about the study.
- -
- I will not receive any financial compensation.
- -
- The decision to allow the analysis of my data is completely voluntary.
- -
- If I decide freely and voluntarily to allow the evaluation of my data and those of my child, I will have the right not to be informed of the results of the investigation.
- -
- The evaluation of all data (clinical, demographic and background) will never pose an additional danger to my child’s health.
- -
- The information about my personal and health data will be incorporated and processed in a computerized database complying with the guarantees established by the General Data Protection Regulation, as well as Organic Law 3/2018, of December 5, Protection of Personal Data and guarantee of digital rights.
- -
- I understand that my child’s participation is voluntary.
- -
- I understand that all of my child’s data will be treated confidentially.
- -
- I understand that I can withdraw my child from the study:
Appendix C. Patient Medical History and Report
ANAMNESIS. | ||
Name: | Identification Code: | |
Name and ID father/mother/legal guardian: | ||
Address: | Phone: | |
DNI: | Email: | |
Date of birth: | Age: | |
Weight: | Height: | BMI: |
Allergies: | Background: | |
Standing number: | Gender: Male/Female | |
Level of physical activity: | High/Medium/Low | |
Exploration-Assessment | ||
IPF | Punctuation: | Pronated/Normal/Supinate |
Navicular Drop | (mm) | |
Double Heel Rise Test | Positive/Negative | |
Single Heel Rise Test | Positive/Negative | |
Pain (VAS scale) | Symptomatic/Asymptomatic | Punctuation: |
PRCA | (degrees) | |
Windlass Test | Positive/Negative | |
Arc height index | Punctuation: | |
Maximum pronation test | Positive/Negative | |
ASA axis | Lateralized/Neutral/Medialized | |
Supination resistance test | High/Moderate/Low | |
Chippaux-Smirak Index | (cm) | |
Beighton scale | Punctuation: | Hyperlax/Normal |
Type of forefoot | Abduccido/Neutral/Adducido | |
Footwear | Heel level: Medial/Center/Lateral | |
Podoscope | Pronate/Supine/Neutral | |
Pronation Angle | (degrees) | |
Silfverskiold Test | (degrees) | |
Navicular height | (mm) | |
Pressure platform | ||
Maximum pressure zone: | ||
Center of gravity | ||
Gait progression line | ||
Load/weight percentage | Left | Right |
Ant: Post: | Ant: Post: | |
Left: | Dx: |
- Tiptoe for 1 min.
- Walk with the outer lateral edge of the foot for 1 min.
- Stand on tiptoe, hold on for 2 s and go down 15 times.
- Hold a tennis ball with your heels and stand on tiptoe without the ball falling, hold 2 s and go down. Perform 15 repetitions.
- Take marbles or pens with your toes and try to put them in a bucket or change them for 1 min.
- Stand on a towel or paper and crumple it with your toes, make this gesture for a minute.
- Standing try to increase the arch of the foot making the greatest possible effort, do 15 repetitions.
- To finish, standing with a ball under the sole of the foot make pressures at different points of the foot and perform stretching of the triceps sural with extended knee and bent knee.
- During the first week, the plantar orthoses should be implanted progressively, that is, on the 1st day for two hours, on the 2nd day for 4 h and so on.
- Plantar orthoses are for daily use whenever the child is standing or walking, that is, they must be worn every day for as many hours as possible.
- They can be washed with soap and cold water.
- Do not put them near a heat source, such as on top of a radiator.
- If they cause discomfort or signs of inflammation, redness or blisters appear on their skin, remove their child’s plantar orthoses and contact the clinic.
Appendix D. Necessary Material and Budget
MATERIALS | COST |
Pressure platform, computer, stretcher, goniometer, scissors, vacuum, polisher, podoscope, printer, SPSS package, pedigraph | €0 |
Consumables: folios, pens, stretcher sheets, printer ink, gloves, masks, pedigraph ink | 100 € |
Elaboration 168 plantar orthoses: phenolic foams, plaster, polypropylene, EVA linings, glue | 1680 € |
Publication of the article in open access | 2000 € |
Presentation at congresses | 700 € |
TOTAL BUDGET | 4480 € |
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Molina-García, C.; Reinoso-Cobo, A.; Cortés-Martín, J.; Lopezosa-Reca, E.; Marchena-Rodriguez, A.; Banwell, G.; Ramos-Petersen, L. Efficacy of Personalized Foot Orthoses in Children with Flexible Flat Foot: Protocol for a Randomized Controlled Trial. J. Pers. Med. 2023, 13, 1269. https://doi.org/10.3390/jpm13081269
Molina-García C, Reinoso-Cobo A, Cortés-Martín J, Lopezosa-Reca E, Marchena-Rodriguez A, Banwell G, Ramos-Petersen L. Efficacy of Personalized Foot Orthoses in Children with Flexible Flat Foot: Protocol for a Randomized Controlled Trial. Journal of Personalized Medicine. 2023; 13(8):1269. https://doi.org/10.3390/jpm13081269
Chicago/Turabian StyleMolina-García, Cristina, Andrés Reinoso-Cobo, Jonathan Cortés-Martín, Eva Lopezosa-Reca, Ana Marchena-Rodriguez, George Banwell, and Laura Ramos-Petersen. 2023. "Efficacy of Personalized Foot Orthoses in Children with Flexible Flat Foot: Protocol for a Randomized Controlled Trial" Journal of Personalized Medicine 13, no. 8: 1269. https://doi.org/10.3390/jpm13081269