Comparison of Foot Posture, Plantar Pressure, and Postural Balance in Patellofemoral Pain Patients and Healthy Subjects

NCT06314360 | Enrolling By Invitation

• 1 other identifier: BAP_PFS
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Patellofemoral pain syndrome (PFS) is a musculoskeletal problem characterized by pain felt in the front of the knee or behind the patella, commonly affecting individuals in adolescence or young adulthood, especially those engaged in sports such as cycling and running. It is one of the most encountered knee injuries and can have a poor prognosis. The intensity of knee pain increases during functional activities such as stair climbing, squatting, running, and jumping due to the increased patellofemoral joint reaction force. A disturbance in postural stability is observed in individuals with PFS due to pain during functional activities. Studies examining changes in foot posture, plantar pressure, and postural balance in individuals with PFS are quite limited and controversial. Moreover, research that simultaneously investigates these parameters and interprets the results is scarce. Some studies have utilized detailed technical systems such as medical imaging or motion analysis, while practical methods incorporating foot posture and plantar pressure analyses are available and easy to use in clinical settings. There is a lack of literature on the easy assessment and interpretation of plantar pressure, postural balance, and functional activities in individuals with PFS. Within the scope of this project, the plan is to assess plantar pressure, postural balance, and functional activities in individuals with PFS. The aim is to quickly interpret the biomechanical changes occurring in these individuals and guide rehabilitation programs based on the obtained data. The use of practical and fast assessment methods in planning treatments for PFS is crucial for early rehabilitation planning. Practical methods such as foot posture, plantar pressure, and postural balance assessments, which can be used in clinical settings, may provide benefits in shaping rehabilitation goals related to lower extremity alignment in individuals with PFS. The objective of this study is to compare the foot posture, plantar pressure, and postural stability of individuals with PFS with healthy individuals. Additionally, the investigators aim to investigate the relationship between foot posture, plantar pressure parameters, postural balance, and functional level in individuals with PFS. Through these objectives, it will be possible to identify potential parameters that could be effective in rehabilitation processes and contribute to determining treatment programs by revealing biomechanical changes in individuals with PFS.

Conditions

Patellofemoral Pain Syndrome

Keywords

patellofemoral pain; pedobarography; postural stability; foot posture; functionality

Outcome Measures

Primary Outcomes (4)

• Plantar Pressure

  Plantar pressure assessment will be performed with K-Invent K-Plates device. This device has two separate platforms measuring 320x160 mm. Participants will stand on the device with each foot on a platform and pressure data will be collected as max kg and weigth distribution.

  3 minutes, in the baseline assessment session.

• Postural Stability

  Postural stability assessment will be performed with K-Invent K-Plates device. This device has two separate platforms measuring 320x160 mm. While the participants are on the device with each foot on a platform, bipodal and then unipodal stance data will be collected respectively. Data will be collected three times for 50 seconds for each stance and stability data such as center of pressure, velocity and ellipse area will be recorded. Higher values show poor balance scores.

  20 minutes, in the baseline assessment session.

• Foot posture

  Foot Posture Index will be used to evaluate foot posture. FPI is a six-item clinical assessment tool used to evaluate foot posture. The six criteria used in the evaluation are talar head palpation, supra malleolar and infra malleolar curvature, position of the calcaneal in the frontal plane, protrusion in the talonavicular joint region, compliance of the medial longitudinal arch, and abduction/adduction of the forefoot. Each API component is scored from -2 to +2, with -2 representing clear signs of supination and +2 indicating positive signs of pronation. The total score ranges from -12 to +12. Total scores between 0 and +5 indicate normal/neutral foot posture. Values ≥ +6 are considered pronated foot, while values below 0 are considered supinated foot.

  5 minutes, in the baseline assessment session.

• Functionality

  Functional status will be assessed using Kujala Patellofemoral Pain Form. The questionnare consists of 13 questions. These questions ask whether there is pain during going up and down stairs, squatting, running, jumping and sitting for long periods with the knees flexed; It evaluates whether there is limp, swelling or subluxation of the patella, the amount of atrophy in the quadriceps muscle, flexion deficit and the need for a walking aid. The scoring system ranges from 0-100 points, from worst to best.

  3 minutes, in the baseline assessment session.

Secondary Outcomes (2)

• Pain Assessment

  1 minute, in the baseline assessment session.

• Limb dominance

  30 seconds, in the baseline assessment session.

Study Arms (2)

Subjects with Patellofemoral Pain

Demographic data, pain information, limb dominancy will be collected. Then, functional status will be assessed with Kujala Patellofemoral Pain Form; foot posture will be evaluated with Foot Posture Index; plantar pressure and postural balance values will be collected with the K-Invent K-Plates device.

Other: No intervention.

Healthy Control Subjects

Demographic data, limb dominancy will be collected. Then, functional status will be assessed with Kujala Patellofemoral Pain Form; foot posture will be evaluated with Foot Posture Index; plantar pressure and postural balance values will be collected with the K-Invent K-Plates device.

Other: No intervention.

Interventions

No intervention. OTHER

There is no intervention in this study.

Healthy Control Subjects; Subjects with Patellofemoral Pain

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are diagnosed with patellofemoral pain syndrome, and healthy subjects.

You may qualify if:

• Those who have been experiencing pain for at least 6 months
• Those who met the numerical pain criteria, defined as a minimum of 3 out of 10 points
• Having pain in the activities specifically identified as painful for PFP patients, including prolonged sitting, descending and ascending stairs/slopes, squatting, running, and jumping.
• Those who are without any complaints related to the lower extremities in the last 6 months
• Those who have not undergone lower extremity surgery for any reason
• Those who do not have a diagnosis of neurological or orthopedic diseases

You may not qualify if:

• Those with a history of lower extremity injury in the last 6 months
• Those who had patellofemoral dislocation and/or subluxation
• Those with meniscus and ligament lesions, bone anomalies
• Those who have undergone surgery on any lower extremity joint (hip, knee, or ankle)
• Those with a history of lower extremity injury in the last 6 months
• Those who are asymptomatic with a history of patellofemoral dislocation and/or subluxation
• Those who are asymptomatic with meniscus and ligament lesions, bone anomalies
• Those who have undergone lower extremity surgery

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University

Ankara, Ankara/Sıhhıye, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Patellofemoral Pain Syndrome

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Hande Guney

  Hacettepe University Faculty of Physical Therapy and Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Early Orthopaedic Rehabilitation Unit

Study Record Dates

• First Submitted: January 26, 2024
• First Posted: March 18, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: October 1, 2024
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)