- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06063889
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
Completed
Conditions
Intervention / Treatment
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
Observational
Enrollment (Actual)
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 Locations
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Giza
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Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
- Outpatient clinic of faculty of physical therapy, Ahram Canadian University
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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
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)
- 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).
- Grade 2-3 KOA cases according to Kelgren-Lawrance classification
- Having knee pain for at least 6 months.
- 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:
- Patellar subluxation
- Surgery in any joint of the lower limb
- Meniscal injury
- Ligament instability
- Patients who received intra-articular injection in the knee in the last 6 months
- Patients with problems in the hip and ankle
- 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 |
Intervention / Treatment |
|---|---|
|
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.
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
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.
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Baseline
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Forward Step Down Test (FSDT)
Time Frame: Baseline
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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.
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Baseline
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Single Leg Hop Test (SLHT)
Time Frame: Baseline
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n this test, participants hop forward as far as possible on one leg, and the distance hopped is recorded.
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Baseline
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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.
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Baseline
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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.
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- 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)
July 20, 2023
Primary Completion (Actual)
February 2, 2024
Study Completion (Actual)
February 2, 2024
Study Registration Dates
First Submitted
September 26, 2023
First Submitted That Met QC Criteria
September 26, 2023
First Posted (Actual)
October 3, 2023
Study Record Updates
Last Update Posted (Actual)
August 6, 2024
Last Update Submitted That Met QC Criteria
August 5, 2024
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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