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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06407713
Other study ID # REC/RCR & AHS/23/0186
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2, 2024
Est. completion date August 2024

Study information

Verified date June 2024
Source Riphah International University
Contact Imran Amjad, PHD*
Phone 03324390125
Email imran.amjad@riphah.edu.pk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

A Randomized Clinical Trial will be conducted at Nawaz Sharif Social Security Hospital, Multan Road, Lahore through convenience sampling technique on 55 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 55
Est. completion date August 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 30 Years
Eligibility 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 Design


Intervention

Other:
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
Hip abductor 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

Locations

Country Name City State
Pakistan Nawaz Sharif social security hospital Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Riphah International University

Country where clinical trial is conducted

Pakistan, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary NPRS 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
Primary Navicular drop test 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
Primary Lower extremity functional scale 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
Primary Universal goniometer 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
See also
  Status Clinical Trial Phase
Completed NCT03993470 - The Effects of Short-foot Exercises in Foot Posture N/A
Completed NCT03099512 - The Foot Exercises in Patellofemoral Pain N/A