Effects of Agility Training With and Without Foot Mobilization In Patellofemoral Pain Syndrome.

November 3, 2024 updated by: Riphah International University

Effects of Agility Training With and Without Foot Mobilization On Pain, Balance and Functional Performance In Patellofemoral Pain Syndrome.

Patellofemoral pain syndrome (PFPS) is referred to as peripatellar or retro-patellar pain, which is characterized by alterations in the physical and biomechanical features of the patellofemoral joint. Risk factors for PFPS include: anatomic anomalies, mal-alignment and altered biomechanics of the lower extremity, muscle dysfunction, patellar hypermobility, poor quadriceps, or iliotibial band flexibility, surgery, tight lateral structures, training errors or overuse and trauma. The aim of this study is to compare the effects of foot mobilization with and without agility training on pain, balance and functional performance in patellofemoral pain syndrome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A Randomized Clinical Trial will be conducted at Riphah Clinic Lahore, Al Rehman Hospital, through convenient purposive sampling technique on 42 patients which will be allocated through using simple randomization into Group A and Group B. Group A will be treated with agility training and foot mobilization in patellofemoral pain syndrome and Group B will be treated with agility training without foot mobilization in patellofemoral pain syndrome thrice a week for 6 weeks. Outcome measures will be conducted through pain (NPRS), Kujala patellofemoral pain scale, Y balance test and Navicular droop test before and after 6 weeks. Data will be analyzed using SPSS software version 25.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Recruiting
        • Al- Rehman Hospital
        • Contact:
        • Principal Investigator:
          • Hira Nawaz, MS-OMPT

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Clinical signs of patellofemoral pain syndrome such as retro patellar pain, crepitation, and pain with patellar grinding more than 6 months.

  • Both genders of 20-40 years of age.
  • Presence of pain on step down from a 25 step or double leg squat and sitting with knee bent greater than 15 min.
  • Pain more than 4 on NPRS scale.
  • Individual with anterior left/right asymmetries greater than 4 cm on Y balance test
  • Excessive calcaneal eversion measured at 6° in the relaxed posture(6).

Exclusion Criteria:

  • History of ligament and meniscal injury.
  • History of lower limb fractures.
  • History of post-surgical condition of lower limb
  • History of systemic, connective tissue or neurologic condition

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Agility Training with Foot Mobilization
Agility Training with Foot Mobilization along with simple conventional treatment
Other: Agility Training with Foot mobilization.
Agility training with foot mobilization with the frequency of 3 sets of 10 repetitions thrice per week for a total six weeks. Pre and post intervention values will be taken on 1st day and after six weeks. Agility training includes side stepping, braiding activities, and front and back crossover steps during forward ambulation, shuttle walking, multiple changes in direction during walking on therapist command. TJM is a grade III Maitland technique and is applied with a high amplitude from the end range and 1s of vibration in the middle range of the joint through a linear motion to where tissue resistance is felt in the prone position, the patient is supported by a towel placed under the foot. Two sets of 5 min total were performed for 6weeks.
Other Names:
  • Simple conventional Treatment
Active Comparator: Agility Training without Foot Mobilization.
Agility training without foot mobilization along with simple conventional treatment.
Other: Agility Training without Foot mobilization
Agility training includes side stepping, braiding activities, and front and back crossover steps during forward ambulation, shuttle walking, multiple changes in direction during walking on therapist command. Comprising of Hot pack and TENS for 10 minutes and Ultrasound for 5 minutes . Comprising of conventional exercises were given for 3 sessions per week for 6 weeks. It includes semi squat, quadriceps isometric, terminal knee extension with elastic band, terminal knee extension in supine position, and adductor squeeze in crook lying (squeeze the ball).
Other Names:
  • Simple Conventional Treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS):
Time Frame: 6 weeks
The outcome was the 11-point NPRS to measure pain intensity. The NPRS defines pain intensity from 0 to 10 points, with 0 and 10 points indicating no pain and the most severe pain respectively. The reported test-retest reliability (intraclass correlation coefficient [ICC]) was 0.76, demonstrating it to be a good indicator of pain intensity.
6 weeks
Kujala Patellofemoral Pain Scale
Time Frame: 6 weeks
Anterior knee pain scale is frequently referred as Kujala scale. It's a 13 item questionnaire including different items on pain related to function and activities. The items assessed in the questionnaire are patellar subluxation, claudication, pain, walking, climbing stairs and prolonged sitting with the knees flexed. It has a score from 0 to 100 points, where 100 means without pain and functional limitations and 0 means constant pain and various functional limitations.
6 weeks
Y Balance Test
Time Frame: 6 weeks
The YBT assesses the balance by challenging his postural control system in 3 (anterior, posteromedial, and posterolateral) of the 8 SEBT (star excursion balance test) directions and has been advocated as a method for assessing dynamic balance (requires strength, flexibility and proprioception). The Y balance score was calculated by dividing the sum of the maximum reach distance in the anterior (A), posteromedial (PM), and posterolateral (PL) directions by 3 times the limb length (LL) of the individual, then multiplied by 100.
6 weeks
Navicular Droop Test
Time Frame: 6 weeks
Position the patient in standing so there is full weight-bearing through the lower extremity and ensure the foot is in the subtalar joint neutral position ("talar head congruent"). Mark the most prominent part of the navicular tuberosity and measure its distance from the supporting surface floor or step. Ask the patient to relax and then measure the amount of sagittal plane excursion of the navicular with a ruler. Alternatively, the test can also be performed in reverse, measuring from relaxed position up to talar neutral in standing postion. Many clinicians also choose to perform this test by marking the start and end position of the navicular on an index card placed along the inside of the foot and then measure the change with a ruler. The ICC2,1 values in the sitting and standing positions were 0.93 and 0.95, respectively, indicating significantly high inter-rater reliability.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ali Raza, MS-OMPT, Riphah International University

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

Study record dates

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 5, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/24/0131

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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