Intrinsic Foot Muscle Training With and Without Hip Abductor Muscle Strengthening in Pronation Distortion Syndrome

December 20, 2024 updated by: Riphah International University

Effects of Intrinsic Foot Muscle Training With and Without Hip Abductor Muscle Strengthening on Pain and Functional Mobility in Patients With Pronation Distortion Syndrome

Pronation distortion syndrome is one of the most common abnormalities in the lower extremity that causes alterations in the structures of the skeletal parts of the foot. The aim of the study will be to compare the effects of intrinsic foot muscle with and without hip abductor muscle strengthening on pain and functional mobility in patients with Pronation Distortion Syndrome.

Study Overview

Detailed Description

A Randomized Clinical Trial will be conducted at Nawaz Sharif Social Security Hospital, Multan Road, Lahore through convenience sampling technique on 54 patients which will be allocated using simple random sampling through computer generated method into Group A and Group B. Group A will be treated with intrinsic foot muscle training at the frequency of 4 sets with 15 repetitions and Group B will be treated with hip abductor muscle strengthening at the frequency of 3 sets with 15 repetitions; session would be conducted thrice a week. Outcome measures will be conducted through numeric pain scale and lower extremity functional scale after 6 weeks. Data will be analyzed during SPSS software version 25. After assessing normality of data by Kolmogorov-Smirnov test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab
      • Lahore, Punjab, Pakistan, 54500
        • Nawaz Sharif social security hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ages 20-30 years
  • Both male and female gender
  • Foot pronation on observation
  • Navicular Drop Test more than 10 mm (measured in weight bearing and non- weight bearing positions distance between ground and navicular tuberosity and difference calculated)
  • Increased Q angle : Males: > 16; females >18

Exclusion Criteria:

  • Other deformities such as tarsal coalition and vertical talus
  • Any history of surgery involving both lower extremities
  • Neuromuscular disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: intrinsic foot muscle training.
Intrinsic foot muscle training would be performed
The duration of intervention will be 6 weeks, 3 sessions a week, a total of 18 sessions will be given to the study participants. Each session will last for 30 minutes. Conventional physical therapy will be given to participants along with intrinsic foot muscle training
Active Comparator: intrinsic foot muscle training with hip abductor muscle training
hip abductor muscle strengthening would be administered alongside intrinsic foot muscle training
The duration of intervention will be 6 weeks, 3 sessions a week, a total of 18 sessions will be given to the study participants. Each session will last for 30 minutes. Conventional physical therapy will be given to participants along with intrinsic foot muscle training
The duration of intervention will be 6 weeks, 3 sessions a week, a total of 18 sessions will be given to the study participants. Each session will last for 30 minutes. Conventional physical therapy will be given to participants along with hip abductor muscle training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NPRS
Time Frame: 6th week
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain The Numerical Pain Rating Scale (NPRS) is a subjective measure in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).
6th week
Lower extremity functional scale
Time Frame: 6th week
The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals. It will be used to monitor the patient over time and to evaluate the effectiveness of the interventions.
6th week
Universal goniometer
Time Frame: 6th week
Universal goniometer is a tool that measures an angle or permits the rotation of an object to a definite position. It- has three parts: body, fulcrum and arms (stationary and moving)
6th week
Navicular drop test
Time Frame: 1st day
Used as an indicator of foot. Height of the navicular tuberosity from the ground is measured with the subject being non-weight bearing and then weight bearing, height of the navicular tuberosity is measured. The difference is determined. A difference of 10 > mm will be considered as flexible flatfoot. ND test has proven valid and reliable for the assessment of the medial arch
1st day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rabiya Noor, PHD, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2024

Primary Completion (Actual)

July 1, 2024

Study Completion (Actual)

August 15, 2024

Study Registration Dates

First Submitted

May 6, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 9, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 20, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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