NCT06761040

Brief Summary

pronation distortion syndrome is a common postural distortion of the lower extremity, involving the anterior part of the leg. It may cause pain in the leg and disturbances in the tarsal part, in addition to distal and proximal parts. 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 is also associated with a union and increased pressure on the medial parts of the first and second metatarso phalangeal joints. The characteristics of pronation distortion syndrome due to 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 in case of hyperpronation. The randomized clinical trial study design will be used with the sample of 48 womens. The data will be collected from ganga ram hospital and mukhtara rafique welfare hospital by using convenient sampling technique.The inclusion criteria Ages 30-35 years, Female gender, BMI of overweight women (25-29.9). Foot pronation on observation, Navicular Drop Test more than 10mm (measured in weight bearing and non-weight bearing positions distance between ground and navicular tuberosity and difference calculated), Increased Q angle :females 15-18. The exclusion criteria is Other deformities such as tarsal coalition and vertical talus, BMI under weight,normal,obese.Any history of surgery involving both lower extremities.and Neuromuscular disorder(GBS,MG,Muscular dystrophies extremities)\|.The tools used is Numeric Pain Rating Scale (NPRS), Navicular drop test, Goniometer for Q angle measurement, and Lower extremity functional scale (LEFS). Data will be analyzed by using SPSS version 26,0.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Start

First participant enrolled

September 15, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 1, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 7, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 1, 2025

Last Update Submit

January 1, 2025

Conditions

Keywords

Intrinsic Foot MuscleHip AbductorPronation Distortion Syndrome

Outcome Measures

Primary Outcomes (3)

  • Goniometer

    universal goniometer has been shown to have good to excellent reliability, and is more reliable than visual estimation especially with inexperienced examiners.The Q angle is formed between a line representing the resultant line of force of the quadriceps (connecting a point near the anterior superior iliac spine (ASIS) to the mid-point of the patella) and a line from the center of the patella to the center of the tibial tubercle. In women, the Q angle should be less than 22 degrees with the knee in extension and less than 9 degrees with the knee in 90 degrees of flexion.normal 14 to 16. In female 15 degree.

    baseline and fourth week

  • Numeric Pain Rating Scale

    The Numeric Pain Rating Scale (NPRS) that is a unidimensional measure of pain intensity in adults,including those with chronic pain due to rheumatic diseases. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.

    baseline and fourth week

  • Navicular Drop Test:

    The ND test was performed to confirm whether subjects had flexibility flatfoot.The examiner measured the height of the navicular tuberosity from the ground with the subject being non-weight bearing.Subject then stood,with weight bearing equally on both feet,as the examinar remeasured the height of the navicular tuberosity.The difference in the height of the navicular tuberosity between weight bearing and non weight bearing situation was determined.A difference of 10\>mm was considered as flexibal flat foot.ND test have proven valid and reliable for the assessment of the medial arch.

    baseline and fourth week

Study Arms (2)

Intrinsic foot muscle training

EXPERIMENTAL

Technique In intrinsic foot muscle training, there are following exercises: 1. Toe spread out 2. First toe extension 3. Second to fifth toe extension

Other: Intrinsic foot muscle training

hip abductor muscle training with intrinsic foot muscle training.

ACTIVE COMPARATOR

Hip abductor muscle training consists of the following two exercise using 1. Resisted hip abduction 90° (2 sec hold; 3 sets × 10 reps) 2. Resisted hip abduction 45° (2 sec hold; 3 sets × 10 reps)

Other: Intrinsic foot muscle trainingOther: hip abductor muscle training with intrinsic foot muscle training

Interventions

Technique In intrinsic foot muscle training, there are following exercises: 1. Toe spread out 2. First toe extension 3. Second to fifth toe extension The exercise would be performed in following positions 1. Sitting position for the first 2 weeks (3sec hold; 4 sets ×15 reps) 2. Standing position on the 3rd and 4th weeks (8sec hold; 4 sets × 8 reps) 3. One-leg standing position during the 5th and 6th week (20 sec hold;4 sets ×3 reps)

Intrinsic foot muscle traininghip abductor muscle training with intrinsic foot muscle training.

Hip abductor muscle training consists of the following two exercise 1. Resisted hip abduction 90° (2 sec hold; 3 sets × 10 reps) 2. Resisted hip abduction 45° (2 sec hold; 3 sets × 10 reps) Standard treatment * Shoe insoles (eight hours a day, medial longitudinal arch support,raised for by about 1.8 cm) * Stretching of Hamstrings and Calf muscles (3 times for 30 seconds hold) Number of Sessions Per Week : 3 times Per week for 6 weeks

hip abductor muscle training with intrinsic foot muscle training.

Eligibility Criteria

Age30 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Ages 30-35 years
  • Female gender
  • BMI of overweight women (25-29.9)
  • Foot pronation on observation
  • Navicular Drop Test more than 10mm (measured in weight bearing and non-weight bearing positions distance between ground and navicular tuberosity and difference calculated).(16)
  • Increased Q angle :females 15-18

You may not qualify if:

  • Other deformities such as tarsal coalition and vertical talus.
  • BMI underweight,normal ,obese.
  • Any history of surgery involving both lower extremities.
  • Neuromuscular disorder(GBS,MG,Muscular dystrophies extremities.).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ganga Ram Hospital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (3)

  • Mulligan EP, Cook PG. Effect of plantar intrinsic muscle training on medial longitudinal arch morphology and dynamic function. Man Ther. 2013 Oct;18(5):425-30. doi: 10.1016/j.math.2013.02.007. Epub 2013 Apr 28.

    PMID: 23632367BACKGROUND
  • 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
  • Lee DR, Choi YE. Effects of a 6-week intrinsic foot muscle exercise program on the functions of intrinsic foot muscle and dynamic balance in patients with chronic ankle instability. J Exerc Rehabil. 2019 Oct 28;15(5):709-714. doi: 10.12965/jer.1938488.244. eCollection 2019 Oct.

    PMID: 31723561BACKGROUND

Study Officials

  • Rabiya Noor, PHD

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

January 1, 2025

First Posted

January 7, 2025

Study Start

September 15, 2024

Primary Completion

December 30, 2024

Study Completion

January 15, 2025

Last Updated

January 7, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations