- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06407713
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
Status
Completed
Conditions
Intervention / Treatment
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
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Punjab
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Lahore, Punjab, Pakistan, 54500
- Nawaz Sharif social security hospital
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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
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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
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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).
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6th week
|
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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.
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6th week
|
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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)
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6th week
|
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Navicular drop test
Time Frame: 1st day
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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
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1st day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
General Publications
- 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.
- 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.
- Elsayed W, Alotaibi S, Shaheen A, Farouk M, Farrag A. The combined effect of short foot exercises and orthosis in symptomatic flexible flatfoot: a randomized controlled trial. Eur J Phys Rehabil Med. 2023 Jun;59(3):396-405. doi: 10.23736/S1973-9087.23.07846-2. Epub 2023 Mar 29.
- 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.
- Kim JS, Lee MY. The effect of short foot exercise using visual feedback on the balance and accuracy of knee joint movement in subjects with flexible flatfoot. Medicine (Baltimore). 2020 Mar;99(13):e19260. doi: 10.1097/MD.0000000000019260.
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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