NCT05347186

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

July 13, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

April 21, 2022

Last Update Submit

July 12, 2023

Conditions

Keywords

PronationPostureDistortionNavicularFunction

Outcome Measures

Primary Outcomes (5)

  • Functional Movement screen test

    The Functional Movement Screen (FMS) test has been used for devising functional evaluation programs. This set of tests was designed using 7 movement patterns for the simultaneous evaluation of mobility and stability. This set of tests include the deep squat, hurdle step, inline lunge, shoulder mobility, active straight-leg raise, trunk stability push-up, and rotatory stability. The intrarater test-retest and interrater reliability of the FMS composite score resulted in an ICC of 0.76

    8 weeks

  • Navicular drop test

    It is a simple test that is clinically used to measure the range of eversion and sagittal deformation of the mid-foot.

    8 weeks

  • Valgus angle by Goniometer

    This factor is determined by measuring the hindfoot valgus angle (the angle behind the ankle).The natural angle is 180 and an angle more than 9 degrees is considered as hyper pronation. Ankle dorsiflexion reliability, ICC 0.12-0.73 and validity 0.51-0.83

    8 weeks

  • Knock Knee by Sliding caliper

    To measure the distance, the intercondylar and intermalleolar points are identified. The internal condyles of the knee and the protruding parts in the internal area of the lower end of the tibia and the upper section of the ankle joint are considered as the internal ankles of the feet. Then, these distances are measured using a caliper. The intra-rater and inter-rater reliability values of this test have been reported as good and excellent i.e., 0.997

    8 weeks

  • Lumbar lordosis measured by Kidoz Flexible ruler

    Using this method, the average lordosis angle in healthy individuals is shown to be up to 50.9 degrees and for the age group of younger than 14 years, the angle is up to 34.45 degrees, while for the age group of 15-25 years, the angle up to 32.20 degrees is considered normal. Flexible ruler shas high intra-rater reliability to be 0.991

    8 weeks

Study Arms (2)

Systematic corrective exercises and non-biomechanical functional exercises

EXPERIMENTAL
Other: Systematic corrective exercises and non-biomechanical functional exercisesOther: Non biomechanical functional exercises

Non biomechanical functional exercises.

OTHER
Other: Non biomechanical functional exercises

Interventions

1. Restraint exercise or self-release: will involve the gastrocnemius muscle, soleus muscle, fibula, knee compressor muscles, adductors of the thighs, the short head of the biceps femoris, and iliotibial band for 30 seconds, using a foam roller. 2. Static stretching drills: involving the soleus and gastrocnemius muscles on an inclined plane, tensor fasciae latae muscle, short head of the biceps femoris, and ilio- psoas muscle; 3. Resistance exercises: will consist of strengthening the eccentric muscles of the feet including dorsiflexion and knee inversion, adduction, and extension, external rotation of the hip joint with TheraBand exercise band, and strengthening the intrinsic muscles of the foot. 4. Integrative exercises: including the star balance test on all planes and resistive exercises.

Systematic corrective exercises and non-biomechanical functional exercises

Conventional treatment involved Non biomechanical Functional exercises (NBF), these exercises indicated for the control group consists of dorsal and plantar flexion of the metatarsophalangeal joints in unloading of the subject in a long sitting position on a chair or couch with the knee at 90â—¦ for a period of eight weeks. Feet will be in hanging position to allow plantar flexion smoothly. The exercises will carry out daily without any kind of resistance for a period of 30s. A total of five series will be completed for each foot. These exercises will be considered as non-therapeutic which might have affected the foot's posture.

Non biomechanical functional exercises.Systematic corrective exercises and non-biomechanical functional exercises

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ibrahim medical Centre Lahore.

Lahore, Punjab Province, 54000, Pakistan

Location

Riphah Rehabilitation Center

Lahore, Punjab Province, 54000, Pakistan

Location

Related Publications (8)

  • 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.

    PMID: 34912505BACKGROUND
  • 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.

    PMID: 32217211BACKGROUND
  • 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.

    PMID: 27134383BACKGROUND
  • 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.

    PMID: 32214390BACKGROUND
  • 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.

    PMID: 32645830BACKGROUND
  • 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.

    PMID: 30517043BACKGROUND
  • 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.

    PMID: 32384261BACKGROUND
  • 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.

    PMID: 32904291BACKGROUND

Study Officials

  • Saima Zahid, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2022

First Posted

April 26, 2022

Study Start

April 25, 2022

Primary Completion

December 25, 2022

Study Completion

January 10, 2023

Last Updated

July 13, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations