NCT06407713

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 2, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 9, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

2 months

First QC Date

May 6, 2024

Last Update Submit

December 20, 2024

Conditions

Keywords

ExerciseFunctional MobilityMuscle strengthNavicular dropPainPronation

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

intrinsic foot muscle training.

ACTIVE COMPARATOR

Intrinsic foot muscle training would be performed

Other: Intrinsic foot muscle training

intrinsic foot muscle training with hip abductor muscle training

ACTIVE COMPARATOR

hip abductor muscle strengthening would be administered alongside intrinsic foot muscle training

Other: Intrinsic foot muscle trainingOther: Hip abductor muscle training

Interventions

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

intrinsic foot muscle training with hip abductor muscle trainingintrinsic 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

intrinsic foot muscle training with hip abductor muscle training

Eligibility Criteria

Age20 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nawaz Sharif social security hospital

Lahore, Punjab Province, 54500, Pakistan

Location

Related Publications (5)

  • 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
  • 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.

    PMID: 36988565BACKGROUND
  • 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
  • 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.

    PMID: 32221061BACKGROUND
  • 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

MeSH Terms

Conditions

Motor ActivityPain

Condition Hierarchy (Ancestors)

BehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rabiya Noor, PHD

    Study Principal Investigator

    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

May 6, 2024

First Posted

May 9, 2024

Study Start

May 2, 2024

Primary Completion

July 1, 2024

Study Completion

August 15, 2024

Last Updated

December 27, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations