Maximal Rate of Force Development of Ankle Muscles and Functional Ability in Patients With Knee Osteoarthritis

August 5, 2024 updated by: Mohamed Magdy ElMeligie, Ahram Canadian University

Assessment of Maximal Rate of Force Development of Ankle Muscles and Its Association Functional Ability in Patients With Knee Osteoarthritis

This study is a detailed assessment of the maximal rate of force development of ankle muscles and its association with functional ability in patients with knee osteoarthritis (OA).

Study Overview

Status

Status

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

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

This research is designed to study the link between force development in ankle muscles and functional abilities in knee OA patients. It aims to understand the influence of ankle muscle strength, specifically plantar flexors, on the stability, pain, and functionality of patients with knee OA. The study will analyze the rate of force development, its importance in explosive strength improvement, and impact on preventing knee injuries. Furthermore, it will investigate the compensatory mechanism of the plantar flexors developed by patients in advanced stages to balance other muscle failures.

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.
Observational

Enrollment (Actual)

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.
126

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 Contact Backup

  • Name: AYA KHALIL, Ph.D
  • Phone Number: +2010055996022

Study Locations

  • Egypt
    • Giza
      • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
        • Outpatient clinic of faculty of physical therapy, Ahram Canadian University

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients suffering from knee osteoarthritis.

Description

Inclusion Criteria:

  • Group 1 (Knee OA group)

    1. Patients diagnosed with knee osteoarthritis according to Performance of the 2018 classification criteria for early stage knee OA was tested using data from the Osteoarthritis Initiative (OAI (Leung et al.,2020).
    2. Grade 2-3 KOA cases according to Kelgren-Lawrance classification
    3. Having knee pain for at least 6 months.
    4. The visual analog scale (VAS) score being at least 3 or more.
  • Group 2 (Healthy control group) 1. Individuals with no signs or symptoms of Knee OA or other neurological or musculoskeletal conditions.

Exclusion Criteria:

  1. Patellar subluxation
  2. Surgery in any joint of the lower limb
  3. Meniscal injury
  4. Ligament instability
  5. Patients who received intra-articular injection in the knee in the last 6 months
  6. Patients with problems in the hip and ankle
  7. Patients who participated in in another physical therapy program in the last 3 months were not included in the study.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Knee OA Patients
This group consists of patients who have been diagnosed with knee osteoarthritis. They will be subjected to a series of tests to assess the maximal rate of force development of ankle muscles and their functional abilities.
Diagnostic test: Maximal Rate of Force Development Test for Ankle Muscles
This test is designed to measure the maximal rate of force development in the ankle muscles, specifically the plantar flexors. It aims to assess the relationship between the strength of these muscles and the functional ability in patients with knee osteoarthritis. The results from this test will help to understand how lower limb muscle strength influences the symptoms and progression of knee osteoarthritis.
Healthy Control
This group will include healthy individuals without knee osteoarthritis. They will undergo the same series of tests to serve as a control group, enabling the comparison of results with the Knee OA Patients group.
Diagnostic test: Maximal Rate of Force Development Test for Ankle Muscles
This test is designed to measure the maximal rate of force development in the ankle muscles, specifically the plantar flexors. It aims to assess the relationship between the strength of these muscles and the functional ability in patients with knee osteoarthritis. The results from this test will help to understand how lower limb muscle strength influences the symptoms and progression of knee osteoarthritis.

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
Knee Osteoarthritis Outcome Score (KOOS)
Time Frame: Baseline
The KOOS is a questionnaire that assesses five aspects of knee injury and osteoarthritis: pain, symptoms, ADL function, sport and recreation function, and quality of life. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. Higher scores indicate better function and less pain.
Baseline
Forward Step Down Test (FSDT)
Time Frame: Baseline
This functional ability test requires participants to perform as many repetitions as possible in 30 seconds of a specific movement. The number of valid repetitions performed in this duration is recorded.
Baseline
Single Leg Hop Test (SLHT)
Time Frame: Baseline
n this test, participants hop forward as far as possible on one leg, and the distance hopped is recorded.
Baseline
Isokinetic Testing Procedures
Time Frame: Baseline
This procedure involves conducting tests of three (60°/s) or five (120°/s) maximal nonconsecutive efforts with specific rest intervals. Each subject is instructed to exert maximal effort throughout the whole range of motion.
Baseline
Rate of Force Development (RFD)
Time Frame: Baseline
The RFD is a measure of the speed at which the force of a muscle contraction develops. It is typically measured during isometric contractions and provides information about the muscle's explosive strength capacity.
Baseline

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.
Ahram Canadian 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.
  • Study Chair: Abeer Abdelrahman, Ph.D, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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.
July 20, 2023

Primary Completion (Actual)

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.
February 2, 2024

Study Completion (Actual)

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.
February 2, 2024

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).
September 26, 2023

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.
September 26, 2023

First Posted (Actual)

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.
October 3, 2023

Study Record Updates

Last Update Posted (Actual)

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.
August 6, 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.
August 5, 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.
August 1, 2024

More Information

Terms related to this study

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.
  • 012/90002023

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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