NCT06300671

Brief Summary

The lower extremity consists of segments that can be affected by the relative position of each other. Deviation of one segment from its normal alignment in the lower extremity also affects the alignment of other segments. The hip joint can affect the frontal plane alignment from proximal to distal, while the foot and ankle complex can also affect it from distal to proximal. Increased subtalar joint pronation in the kinetic chain from distal to proximal; is associated with decreased dorsiflexion angle and increased frontal plane projection angle. It has been shown that ankle dorsiflexion limitation causes changes in the biomechanics and kinematics of landing after jumping, but no study examining the effect of foot pronation on jump tests has been found in the literature. Since the foot is located at the most distal point and acts as a support base for the kinematic chain, the smallest dynamic change in the foot affects the balance of the whole body. Due to foot pronation, changes in the sole contact surface may make it difficult for the foot to adapt to the ground, balance and postural stabilization may be adversely affected, and an increase in the workload of the muscles around the joint may be observed. In another study, it is mentioned that there is limited evidence about the effect of foot posture on postural stability. Although there are studies in the literature examining the effects of subtalar joint pronation on lower extremity alignment and postural stability, studies need to examine the effects of different subtalar joint pronation amounts on lower extremity alignment, jumping performance, and postural stability. Our study will contribute to the literature with this aspect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2024

Completed
Last Updated

August 1, 2024

Status Verified

July 1, 2024

Enrollment Period

5 months

First QC Date

February 6, 2024

Last Update Submit

July 31, 2024

Conditions

Keywords

Subtalar jointHyperpronationKinetic ChainBalance

Outcome Measures

Primary Outcomes (1)

  • Postural Stability

    Static and dynamic balance assessments The Biodex Balance System (BDS) (Biodex Medical Systems Inc., Shirley, New York, USA) will be used. Measurements will be made with bare feet. Each test will last 20 seconds and will be made in 3 measurements with 10-second rest periods. During the measurement, individuals will be asked to stand on their weight-bearing knees in 15° flexion, their non-weight-bearing contralateral knees in 90° flexion, and to look forward by crossing their arms at chest level. In dynamic balance evaluation, the difficulty level of the test will be set to 4.

    Baseline

Secondary Outcomes (5)

  • Frontal Plane Projection Angle

    Baseline

  • Foot and Ankle Ability Measurement

    Baseline

  • Navicular Drop Test

    Baseline

  • Weight bearing lunge test

    Baseline

  • Countermovement jump test without arm swing

    Baseline

Study Arms (3)

Pronation Group

ACTIVE COMPARATOR

Participants with a value between 6-9 according to the foot posture index-6 evaluation will be included in the pronation group.

Other: Foot Posture Index-6

Hyperpronation Group

ACTIVE COMPARATOR

Participants with a value between 10-12 according to the foot posture index-6 evaluation will be included in the hyperpronation group.

Other: Foot Posture Index-6

Neutral Group

ACTIVE COMPARATOR

Participants with a value between 0-5 according to the foot posture index-6 evaluation will be included in the neutral group.

Other: Foot Posture Index-6

Interventions

Foot Posture Index 6 (API-6) is a clinical diagnostic tool that broadly measures whether a foot is in neutral, supination or pronation posture. During the evaluation, individuals' static standing postures in a comfortable position are observed and scored. When using API-6, researchers visually evaluate the foot according to 6 criteria, each rated on a 5-point (-2 to +2) Likert scale. Each item is scored between -2 (supination) and +2 (pronation) and 0 (for neutral position), with the total score being between -12 (high degree of supination) and +12 (high degree of pronation). The grouping of reference values showing foot posture can be summarized as follows; Neutral position from 0 to +5, pronation position from +6 to +9, hyperpronation position from +10 to +12, supination position from -1 to -5, and supination position from -6. It shows a high degree of supination position up to -12. Higher scores represent a more pronated foot posture.

Also known as: Postural stability Assessment, Frontal Plane Projection Angle, Foot and Ankle Ability Measurement, Navicular Drop test, Weight bearing lunge test, Counter movement jump test without arm swing
Hyperpronation GroupNeutral GroupPronation Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Being between the ages of 18-40
  • Pain, difficulty in walking and loss of function, etc. not having complaints
  • Foot posture index value should be between 6-12
  • Not having any orthopedic disease
  • Not having visual or hearing impairment
  • Not having been involved in any physical therapy program in the last 6 months.
  • Not having undergone any surgical procedure on the lower extremity
  • Not using analgesic medication within the specified treatment days throughout the research period.

You may not qualify if:

  • Having a lower extremity congenital anomaly
  • Having a history of lower extremity surgery or planned lower extremity surgery within the next 12 months
  • Having any signs of pain in the lower extremities
  • Having ligament hyperlaxity
  • Having a history of tendon or cartilage injury
  • Having serious illnesses
  • Predominant knee pain from other knee structures, hip or lumbar spine
  • Having a history of using any shoe insert-orthosis-insoles or knee injection in the last 3 months
  • Having any neurological or systemic inflammatory arthritis disorder (neurological involvement that affects movement)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bahcesehir University

Beşiktaş, Istanbul, 34353, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Foot Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • Pelin Pişirici, PT, PhD

    Bahcesehir University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR
  • Ozlem Feyzioğlu, PT, PhD

    Acibadem Mehmet Ali Aydinlar University, Faculty of Health Sciences

    STUDY CHAIR
  • Nurefşan Kaygaz, PT

    Bahcesehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation

    STUDY CHAIR
  • Yahya Süleyman Mollaibrahimoğlu, PT

    Bahcesehir University, Health Sciences Faculty, Physiotherapy and Rehabilitation

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 48 healthy individuals between the ages of 18-40 constitute the population of the study. Participants randomized into neutral, pronation, and hyperpronation groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PT, PhD

Study Record Dates

First Submitted

February 6, 2024

First Posted

March 8, 2024

Study Start

December 15, 2023

Primary Completion

April 30, 2024

Study Completion

July 30, 2024

Last Updated

August 1, 2024

Record last verified: 2024-07

Locations