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Flexible Flatfoot clinical trials

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NCT ID: NCT06211504 Recruiting - Flat Foot Clinical Trials

Sinus Tarsi Implant as an Adjuvant Procedure to Medial Displacement Calcaneal Osteotomy in the Treatment of Mobile Adult Acquired Flatfoot Deformity

Start date: April 11, 2024
Phase: Phase 4
Study type: Interventional

Background: Adult acquired flatfoot deformity (AAFD) is a deformity of the foot which leads to pain and an altered gait pattern. There are several different surgical interventions available for treatment of AAFD. One of the most common treatments for mobile AAFD is medial displacement calcaneal osteotomy (MDCO) with or without adjuvant soft tissue procedures. However, the medial displacement of the calcaneus only aims to correct the deformity in one plane despite AAFD being a deformity of three planes with hypereversion of the calcaneus, anterior translation of the talus over the calcaneus and tilting/drop of the calcaneal head. Because of these multiple forces, the healing of MDCO in the intended position can sometimes be hard to achieve and medial soft tissue is still stressed leading to recurring deformity. The investigators believe that adjuvant insertion of a sinus tarsi implant (STI) could work as an internal splint, protecting soft tissue procedures on the medial side, reversing anterior translation of the talus, opposing calcaneus eversion, and lifting talar head. This additional procedure will create a better correction of the deformity with enhanced appearance of the foot and better long-term functional results. Methods: This is a multi-center randomized controlled trial designed to assess the efficacy of STI as an adjuvant procedure to MDCO in patients with mobile AAFD (Stage IIA). Patients aged 16 to 75 years, referred to one of the orthopedic centers involved in this study, will be invited to participate if they fulfil the trials eligibility criteria. In total, 130 patients who provide informed consent will be randomized to either MDCO with STI or MDCO without STI (65 patients in each group). The included patients will be clinically and radiographically examined. They will also fill out a form before surgery and 4-5 months, 1 year and 2 years postoperatively. The form will include Self-Reported Foot and Ankle Score (SEFAS) and Euro-QoL 5 Dimensions (EQ-5D). The trials primary outcome will be change in Meary's angle. Secondary outcomes include additional radiographic changes, change in SEFAS score, EQ-5D index, pain according to visual analog scale (VAS), satisfaction assessment, clinical outcome measures, the length of postoperative sick-leave and rate of complications. Discussion: This is the first randomized controlled trial assessing the efficacy of a sinus tarsi implant as an adjuvant procedure to MDCO.

NCT ID: NCT05896917 Completed - Flexible Flatfoot Clinical Trials

Comparison of 3D Printed Foot Orthoses With Prefabricated Foot Orthoses

Start date: May 23, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the effects of 3D printed insoles versus prefabricated insoles in otherwise healthy subjects with flatfoot condition. The main question it aims to answer is: - If 3D printed insoles are better in terms of fit, weight, durability, comfort, and effectiveness compared to prefabricated insoles. - If 3D printed insoles are better in terms of reducing pain compared to prefabricated insoles. Participants will be divided in two groups. One group will receive 3D printed insoles and other group will wear prefabricated insoles for four weeks. After four weeks, researchers will record their feedback about their insoles which will help them to compare the two insoles.

NCT ID: NCT05877482 Recruiting - Flexible Flatfoot Clinical Trials

Pediatric Pes Planus: Effect of Insoles With and Without SFE

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

The goal of this randomised control trial is to determine the effects of insoles with and without short foot exercises on pain, disability and foot posture in children with pes planus. The main question[s] it aims to answer are: 1. What are the effects of insoles on pain, disability, and foot posture in children with pes planus? 2. What are the effects of short foot exercises on pain, disability, and foot posture in children with pes planus? 3. What are the combined effects of insoles and short foot exercises on pain, disability, and foot posture in children with pes planus? 4. Is there a significant difference between the effects of insoles alone versus insoles with short foot exercises on pain, disability, and foot posture in children with pes planus? Participants will be asked to signed consent form and divided into two groups. Experimental group will be asked to performed short foot exercises with internal shoe modification (a medial longitudinal arch support) daily for six weeks and Control Group will be asked to perform only internal shoe modification by placing a medial longitudinal arch support insoles inside the shoe. Researchers will compare: 1) Insoles only vs insoles + short foot exercises: This comparison would involve evaluating the effects of wearing insoles alone compared to wearing insoles and performing short foot exercises together to see effect on pain, disability, and foot posture among pes planus children between age group of 08 to 16 years.

NCT ID: NCT05316051 Completed - Flexible Flatfoot Clinical Trials

Effect of Different Foot Orthosis Inverted Angles on Walking Kinematics in Females With Flexible Flatfeet

Start date: November 1, 2022
Phase: N/A
Study type: Interventional

Inverted orthosis is a type of rigid foot orthosis that was designed to aid in controlling high degrees of foot pronation. It is essential to administer patients foot orthoses with different inverted angles, with higher angles prescribed when greater reduction of foot pronation is indicated. However, there is shortage of clinical knowledge regarding the inverted angle in terms of biomechanical changes. The aim of this study is to investigate the effect of different inverted angles of foot orthoses on the walking kinematics in females with flexible flatfeet.

NCT ID: NCT05056298 Completed - Muscle Weakness Clinical Trials

Effect of Insole Added to Exercise in Patients With Bilateral Flexible Flatfoot

Start date: September 15, 2021
Phase: N/A
Study type: Interventional

Pesplanus, commonly known as 'flatfoot,' is a common pathomechanical condition characterized by a lowered medial longitudinal arch (MLA) and exaggerated pronation. There are two general types of flatfoot : flexible flatfoot and rigid flatfoot Flexible flatfoot is the most common form of flat foot. In adult population, it was reported that prevalence of flexible flatfeet is 13.6%. It has been proved that there is static and dynamic balance deficit in the participants with flatfeet. The extrinsic muscles as posterior tibialis (TP) ) and intrinsic muscles as abductor hallucis (AbdH) act as active subsystem support for the MLA during weight-bearing, standing, and walking. Abnormal alignment of the foot may cause stretch weakness of the foot muscles by elongating beyond the neutral physiological resting position. leading to musculoskeletal dysfunction and overuse injuries. Insoles can assist in maintaining normal alignment of the foot, improve balance as it supports MLA which is essential to stabilize postural sway, they widen the contact surface of the sole of the foot improving stability.

NCT ID: NCT04480177 Completed - Flexible Flatfoot Clinical Trials

Effect of Foot Muscles Training and Foot Orthosis on the Medial Arch in Flatfoot Subjects

Start date: October 27, 2018
Phase: N/A
Study type: Interventional

Orthotic therapy or exercise therapy is the standard conservative treatment for flexible flat foot. Little is known about the effectiveness of their interaction on managing flatfoot. The study aims to evaluate the effect of insoles and short foot exercise on the height and area of the medial longitudinal arch of flexible flatfoot participants as well as the force and pressure.

NCT ID: NCT04381039 Completed - Flexible Flatfoot Clinical Trials

The Effect of Customized Insoles on Biomechanics and Pain in Patients With Functional Flatfoot

Start date: May 1, 2020
Phase: N/A
Study type: Interventional

The aim of present study is to compare the effects of 3D printing customized insoles using different thermoplastic materials on functional flatfoot patients' foot function and biomechanics

NCT ID: NCT04125407 Active, not recruiting - Flexible Flatfoot Clinical Trials

The Effect of Sensorimotor Insoles on Gait Parameters in Adults With Flexible Flatfoot

Start date: October 22, 2019
Phase: N/A
Study type: Interventional

The flatfoot is one of the most common diagnosis in foot. The main goals of its orthotic intervention in adult population are the control of the rearfoot and midfoot movement, the affection of the forefoot position and the minimalization of painful deformities. However, only low-level evidence exists proving the positive effect of orthotic insoles in these patients. The concept of sensorimotor insoles describes besides the simple mechanical correction also the targeted modulation of activity of muscles participated on the correct foot function. The aim of the project is to assess the influence of customized sensorimotor insoles on the lower limbs' kinematics and the activity of lower limbs' muscles in people with diagnosed flexible flatfoot. The study is designed as a crossover interventional study with experimental and control group (allocation ratio 1:1). Participants' lower limbs' kinematics and muscles activity will be assessed on the baseline measurement, immediately after and 3 months after the intervention with sensorimotor insoles in the experimental group. Also, the subjective perceived effect of intervention will be assessed through the research. After a washout period, experimental and control group will swap their roles and another period of 3 months will follow. Same parameters will be assessed both at the beginning and in the end of each period.

NCT ID: NCT03842241 Completed - Flexible Flatfoot Clinical Trials

Effects of Fatigue and Foot Orthoses on Lower Extremity EMG and Biomechanics for Individuals With Flat Foot

Start date: December 5, 2018
Phase:
Study type: Observational

Determine the effects of non-custom made foot orthoses on the kinematics, muscle activity and joint contact force after fatigue and compare the rate of fatigue in flexible flat foot with and without foot orthoses

NCT ID: NCT03154853 Recruiting - Flexible Flatfoot Clinical Trials

Neuromuscular Study to Assess Foot Intrinsic Muscles

Start date: November 4, 2016
Phase: N/A
Study type: Interventional

The purposes of these studies are to investigate: Differences in abductor hallucis muscles'EMG activities during different postural tasks between individuals with normal foot alignment and functional flat foot. Differences in abductor hallucis muscles'H-reflex amplitudes between individuals with normal foot alignment and functional flat foot. Changes in abductor hallucis muscles'EMG activities during different postural tasks after a 3-week short foot exercises training regimen in individuals with functional flat foot. Changes in abductor hallucis muscles'H-reflex amplitudes after a 3-week short foot exercises training regimen in individuals with functional flat foot. hypotheses: Peak-to-peak amplitudes and ratios of abductor hallucis muscles and tibialis anterior muscles during different postural tasks were significantly lower in individual with functional flat foot when compared to those with normal foot alignments. H-reflex amplitudes of abductor hallucis muscles were significantly lower in individual with functional flat foot when compared to those with normal foot alignments. Changes of peak-to-peak amplitudes and ratios of abductor hallucis muscles and tibialis anterior muscles during different postural tasks were significantly different in individuals with functional flat foot after a 3-week short foot exercise training regimen. Changes of H-reflex amplitudes of abductor hallucis muscles were significantly different in individuals with functional flat foot after a 3-week short foot exercise training regimen