Clinical trial NCT05347186: Effects of 8-weeks Systematic Corrective Exercise Program in Pronation Distortion Syndrome
Official title: Effects of 8-weeks Systematic Corrective Exercise Program on Body Posture and Stability in Pronation Distortion Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pronation; Ankle
Distortion
Keywords: Pronation
Posture
Distortion
Navicular
Function
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-04-26
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pronation distortion syndrome is a postural complexity of lower extremity which primarily involves hyper pronation of feet leading to other dysfunctional movement patterns throughout the kinetic chain and gait mechanics. Excessive foot pronation is followed by internal tibial rotation and adduction of knees forming knock knees. This lower extremity distortion pattern causes a chain reaction of muscle imbalances. The objective of this study is to determine effects of 8-Weeks Systematic Corrective Exercise program on Body Posture and stability in Pronation Distortion Syndrome. This study will be a Randomized Controlled trial and will be conducted at Riphah college of rehabilitation sciences and Ibrahim medical Centre Lahore. The study will be completed within the time duration of 10 months. Convenient sampling technique will be used to collect the data. A sample size of Total 36 patients will be taken in this study. Patients will be divided into two groups. Group A will be treated with conventional treatment along with systematic corrective exercise program. Group B will be given conventional treatment only. The groups will participate in the training program one day after the pre-test, three sessions per week for two months. The diagnosis of pronation distortion will be detected by navicular drop in detectable flat feet without pain. Variables to be tested will be, functional movement screen test, navicular drop, knock knees and lordosis, and will be measured before the start of treatment and after 8 weeks of treatment. Data will be analyzed on SPSS 25.

Detailed description: Pronation distortion syndrome is a common postural distortion of the lower extremity, involving the anterior part of the leg. In this deformity, the head of the talus and navicular bones are rotated inward and downward, and the body's center of gravity shifts inward, resulting in flat feet. It may cause pain in the leg and disturbances in the tarsal part, in addition to distal and proximal parts. Excessive foot pronation include inward rotation of the tibia, internal rotation of the thighs associated with flat feet, genu valgum (knock-knee), and increased lordosis thus causing abnormalities in lumbo-pelvic region and lower limb.

In this deformity, peroneal muscle, gastrocnemius muscle, hamstrings, soleus muscle, iliotibial band, adductors, and psoas muscle are functionally tightened, while posterior and anterior tibialis, gluteus Medius, gluteus maximus, vastus medialis, and hip external rotators are inhibited. Excessive pronation will misalign the entire lower body, reducing the ability of powerful muscles like the quadriceps and glutes to maintain force production. Length tension relationships establish that the resting length of a muscle determines whether it can generate optimal tension, if the feet excessively flatten and the femur excessively rotates and adducts, then the joints don't stack, the tissues don't load, and energy is lost. Over time, tissues may become irritated, inflamed or even weakened, which often leads to more serious problems, such as ruptured tendons or stress fractures . The body weight normally falls on the center of the foot, and balance is maintained by the muscle activity of the foot. If the foot becomes diseased or deformed, the foot adapts to perform its functions under the conditions of disease or deformity. Several factors of pronation distortion can increase the likelihood of cuboid syndrome including midtarsal instability, excessive body weight, ill-fitting or poorly constructed orthoses or shoes and inadequate exercise recovery. The postural defects cause pronated subtalar joint, inverted forefoot and instability of mid tarsal joint leading to improper dynamic stabilization. Every degree of subtalar pronation that occurs produces an exponential increase in midtarsal joint instability. Pronated feet are very common among people with flexible flat feet in which the medial longitudinal arch of the foot largely collapses during the stance phase of gait causing over supination and over pronation but restores after removal of body weight. Kinetic coupling of 4 pronated feet alters during improper gait mechanics and results in changes of inter joint angle coordination. This disturbs the inter joint coordination which is involved in determining movement flexibility and stability thus effecting gait pattern leading towards occurrence of injury. In the case of postural distortion, instability and damage to the lower extremity cause hypermobility, and passive instability and more neurological control by the neuromuscular system is required to maintain stability and balance. The instability resulting from a flat foot could cause patho-mechanical problems as well as a compensating action in the close kinematic chain of the lower extremity. Excessive pronation transmitted to internal rotation of the tibia, may cause overloading of the knee joint or may be the cause of other changes in proximal part of the lower extremity. The feet support the body's weight and play the role of levers when an individual is performing work. By performing closed kinetic chain exercises under loads and by increasing the strength of the muscles proximal to the lower extremities, one can correct the hyper pronation of the foot in the distal lower extremities and can prevent ligamentous laxity. This study will determine the effects of 8 weeks systematic corrective exercises on body posture and stability in pronation distortion syndrome. PDS is a postural defect that occurs by initiation of foot hyper pronation that further causes forced tibial rotation, knock knees and progression of lumbar lordosis. Studies suggest women are more prone to pronated feet than men recording prevalence of 20-30 percent.

Furthermore, biomechanical abnormalities reported to be prevalent as 60-90 percent.

In 2020 Ali Golchin et al conducted a study to emphasize on the postural deformities caused by pronation distortion syndrome. It was a randomized controlled trial. In this study functional movement screening were performed to evaluate subjects' performance. Treatment protocol included systematic and corrective exercise program that concluded reduction in likelihood of injury and improvement in posture with subjects with pronated feet.

In year 2020 Marina gil-calvo et al studied the effects of custom-made and prefabricated foot orthoses on kinematic parameters in recreational runners with flat feet dysfunction.

Initial field test was monitored to determine individuals maximum aerobic speed in athletes.

Subjects with history of foot orthosis implementation were excluded. There were three groups, one with custom orthosis, 2nd group underwent with prefabricated orthosis and 3 rd was control group. Foot eversion parameters were measured before and after the intervention.

Findings of the study suggested no significant difference in improvement even after weeks of intervention. Modification in the running mechanics to maintain ideal movement pattern in runners were suggested for better outcome . In 2020 Manuel Pabón-Carrasco et al checked the association of short foot exercises (SFE) with Non biomechanical function (NBF) exercises in the strength development of intrinsic muscles of pronated feet. The intrinsic foot muscle is considered primordial in maintaining the plantar arch and controlling foot posture. A randomized clinical trial was carried out with 85 asymptomatic participants with a bilateral Foot Posture Index (FPI) greater than 6 points.

The pronation of each foot were measured twice. Changes were observed in the ND and FPI pre-intervention and post-intervention for the subjects of each independent group. A tendency of a more neutral position and a decrease of the ND were noted. 6 In 2019, according to Nikkhouamiri F et al, postural abnormalities due to dysfunction of pronated feet can irritate the functional and balance kinematic of walking resulting in skeletal abnormalities and postural control disorder. Navicular drop test was used to asses the flat feet deformity. Given the results, application of corrective exercise program on improving balance and function in female population were effective. Female adolescents showed improved postural control, coordination and stability. Farhan Alam et al in 2019, worked on selective strengthening of tibialis posterior and stretching of iliopsoas on navicular drop, dynamic balance, and lower limb muscle activity in pronated feet. A previous study reported that 20% of the adult population have flatfeet and 12.8% of adults with flatfeet are males and 14.4% are females. The experimental group performed stretching and strengthening of tibialis anterior, iliopsoas and adductor muscles whereas conventional group performed towel curl exercises. Improvement in biomechanical alignment was noted in this study. Ru-Lan Hsieh, MD et al in 2018, conducted a randomized controlled trial study to measure the effects of customized arch support insoles in children with flexible flat and pronated feet.

In this 12-week intervention program subjects went through the measurement of calcaneal inclination angle; hypermobility score and navicular drop test. Physical activity i.e., 10-m normal and fast walking, stair ascent, stair descent, and chair rising were assessed within the intervention. The insoles helped subtalar joint to maintain its normal neutral position during mobility (14). The literature suggests to conduct a study on both males and females with age group more than 16 years. There has been studies that has worked on foot for correction of pronation but the correction of kinetic chain disturbance due to hyper pronation has been in neglection. Given the prevalence of flat feet and influence of proximal and distal chains, this study will be conducted to determine effects of 8-Weeks Systematic CCorrective Exercise program on Body Posture and stability in Pronation Distortion Syndrome.

Eligibility criteria: Inclusion Criteria:

Age 18-25 years

* Male and female university going students
* Navicular drop test greater than 10mm .
* Detection of flexible flat feet without pain.
* Having a normal vision or corrected vision using spectacles or contact lenses

Exclusion Criteria:

The presence of pain or emergence of pain during the study.

* Congenital abnormalities such as club foot, common peroneal nerve injury.
* Visible deformation of foot.
* History of surgery on the ankle, knee, thighs, hip, or back
* Use of assisted devices while walking

Primary outcomes:
measure: Functional Movement screen test
timeFrame: 8 weeks
measure: Navicular drop test
timeFrame: 8 weeks
measure: Valgus angle by Goniometer
timeFrame: 8 weeks
measure: Knock Knee by Sliding caliper
timeFrame: 8 weeks
measure: Lumbar lordosis measured by Kidoz Flexible ruler
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ibrahim medical Centre Lahore.
state: Punjab
city: Lahore
country: Pakistan
facility: Riphah Rehabilitation Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Saima Zahid, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Golchini A, Rahnama N, Lotfi-Foroushani M. Effect of Systematic Corrective Exercises on the Static and Dynamic Balance of Patients with Pronation Distortion Syndrome: A Randomized Controlled Clinical Trial Study. Int J Prev Med. 2021 Oct 19;12:129. doi: 10.4103/ijpvm.IJPVM_303_19. eCollection 2021.
citation: Jafarnezhadgero A, Mousavi SH, Madadi-Shad M, Hijmans JM. Quantifying lower limb inter-joint coordination and coordination variability after four-month wearing arch support foot orthoses in children with flexible flat feet. Hum Mov Sci. 2020 Apr;70:102593. doi: 10.1016/j.humov.2020.102593. Epub 2020 Feb 28.
citation: Goo YM, Kim TH, Lim JY. The effects of gluteus maximus and abductor hallucis strengthening exercises for four weeks on navicular drop and lower extremity muscle activity during gait with flatfoot. J Phys Ther Sci. 2016 Mar;28(3):911-5. doi: 10.1589/jpts.28.911. Epub 2016 Mar 31.
citation: Gil-Calvo M, Jimenez-Perez I, Priego-Quesada JI, Lucas-Cuevas AG, Perez-Soriano P. Effect of custom-made and prefabricated foot orthoses on kinematic parameters during an intense prolonged run. PLoS One. 2020 Mar 26;15(3):e0230877. doi: 10.1371/journal.pone.0230877. eCollection 2020.
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: Alam F, Raza S, Moiz JA, Bhati P, Anwer S, Alghadir A. Effects of selective strengthening of tibialis posterior and stretching of iliopsoas on navicular drop, dynamic balance, and lower limb muscle activity in pronated feet: A randomized clinical trial. Phys Sportsmed. 2019 Sep;47(3):301-311. doi: 10.1080/00913847.2018.1553466. Epub 2018 Dec 5.
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: Ore V, Nasic S, Riad J. Lower extremity range of motion and alignment: A reliability and concurrent validity study of goniometric and three-dimensional motion analysis measurement. Heliyon. 2020 Aug 25;6(8):e04713. doi: 10.1016/j.heliyon.2020.e04713. eCollection 2020 Aug.