Clinical trial NCT06548750: Foot Muscle Strengthening Exercises for Pes Planovalgus
Official title: The Effect of Foot Muscle Strengthening Exercises on Foot Posture, Balance, and Functional Mobility in Children With Pes Planovalgus: A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pes Planus
Keywords: Intrinsic foot muscle
Physiotherapy
Foot core
Flat foot
Extinsic foot muscle
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-08-12
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be an equal number of participants in the two groups randomized by the computer
Primary purpose: TREATMENT

Brief summary: Pes planovalgus is a common foot condition affecting the child population. It is characterized by the partial or complete collapse of the medial longitudinal arch with rearfoot eversion and forefoot abduction, which is associated with changes in lower extremity kinematics during dynamic activity.

The lower extremity chain includes the foot, ankle, knee, and hip joints, with the feet acting as the base of support. However, due to their small size, maintaining balance can be challenging. Any small dynamic change in the foot, as the support base, can impact overall body posture. The foot arch, which can be pronated or supinated, affects proprioceptive input by altering joint movement, contact area, and muscle strategy for stability. Pes planovalgus, characterized by excessive subtalar pronation, lead to instability and hypermobility, requiring more neuromuscular control to maintain balance. As a result, flat feet can cause pathomechanical issues and compensatory actions in the lower extremity chain, affecting overall body balance.

The effectiveness of exercise interventions, particularly foot intrinsic muscle strengthening exercises, in increasing the medial longitudinal arch in individuals with pes planus has been investigated in numerous studies. It is widely accepted that both intrinsic and extrinsic muscle groups play a crucial role in the formation, maintenance, and enhancement of foot arches. However, there is a lack of studies specifically examining the effectiveness of exercises aimed at strengthening these muscles in children with pes planovalgus. Therefore, the purpose of this study is to compare the effects of two corrective exercise programs focused on the improvement of the medial longitudinal arch in children with pes planovalgus: one incorporating routine intrinsic muscle exercises and the other combining them with extrinsic muscle exercises.

Detailed description: Voluntary children who have been diagnosed with pes planovalgus will be included in the study. Signed voluntary consent will be obtained from caregivers. Participants will be divided into two groups. Study groups will be as follows: a) Intervention Group (Intrinsic\&Extrinsic Exercise), b) Control Group (Intrinsic Exercise).

Eligibility criteria: Inclusion Criteria:

* Presence of bilateral pes planovalgus,
* Being between 4-7 years of age,
* Having a body mass index within normal limits

Exclusion Criteria:

* Having high femoral anteversion, internal tibial torsion and metatarsus adductus
* Having leg length inequality
* Having any neurological, rheumatic, musculoskeletal, metabolic and connective tissue disease
* Having a history of pain, deformity or surgery related to the vertebral column and lower extremities
* Having a cognitive, mental or serious psychiatric disease
* Having been involved in any exercise program or sports activity in the last six months

Primary outcomes:
measure: Single Leg Stance Test
timeFrame: change from baseline balance at 2 months
measure: Timed-up and Go Test
timeFrame: change from baseline balance at 2 months
Secondary outcomes:
measure: Range of Motion
timeFrame: 2 times for 8 weeks
measure: Thomas Test
timeFrame: 2 times for 8 weeks
measure: Duncan-Ely Test
timeFrame: 2 times for 8 weeks
measure: Popliteal Angle Assessment
timeFrame: 2 times for 8 weeks
measure: Navicular Drop Test (NDT)
timeFrame: 2 times for 8 weeks
measure: Foot Posture Index-6 (FPI-6)
timeFrame: 2 times for 8 weeks
measure: 6-minutes Walking Test
timeFrame: 2 times for 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University
name: Deniz Tuncer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Huang C, Chen LY, Liao YH, Masodsai K, Lin YY. Effects of the Short-Foot Exercise on Foot Alignment and Muscle Hypertrophy in Flatfoot Individuals: A Meta-Analysis. Int J Environ Res Public Health. 2022 Sep 22;19(19):11994. doi: 10.3390/ijerph191911994.
citation: Hara S, Kitano M, Kudo S. The effects of short foot exercises to treat flat foot deformity: A systematic review. J Back Musculoskelet Rehabil. 2023;36(1):21-33. doi: 10.3233/BMR-210374.
citation: Okamura K, Fukuda K, Oki S, Ono T, Tanaka S, Kanai S. Effects of plantar intrinsic foot muscle strengthening exercise on static and dynamic foot kinematics: A pilot randomized controlled single-blind trial in individuals with pes planus. Gait Posture. 2020 Jan;75:40-45. doi: 10.1016/j.gaitpost.2019.09.030. Epub 2019 Sep 29.
citation: Pabon-Carrasco M, Castro-Mendez A, Vilar-Palomo S, Jimenez-Cebrian AM, Garcia-Paya I, Palomo-Toucedo IC. Randomized Clinical Trial: The Effect of Exercise of the Intrinsic Muscle on Foot Pronation. Int J Environ Res Public Health. 2020 Jul 7;17(13):4882. doi: 10.3390/ijerph17134882.
citation: Haun C, Brown CN, Hannigan K, Johnson ST. The Effects of the Short Foot Exercise on Navicular Drop: A Critically Appraised Topic. J Sport Rehabil. 2020 May 8;30(1):152-157. doi: 10.1123/jsr.2019-0437.
citation: Moon DC, Kim K, Lee SK. Immediate Effect of Short-foot Exercise on Dynamic Balance of Subjects with Excessively Pronated Feet. J Phys Ther Sci. 2014 Jan;26(1):117-9. doi: 10.1589/jpts.26.117. Epub 2014 Feb 6.