Knee OsteoarthritisNCT06063889
Maximal Rate of Force Development of Ankle Muscles and Functional Ability in Patients With Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Knee Arthritis, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 30 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis, Knee Arthritis
- What is being tested?
- Maximal Rate of Force Development Test for Ankle Muscles
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jul 2023to 2 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients suffering from knee osteoarthritis.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
About this study
Official title: 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).
Read the 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.
- Conditions
- Knee Osteoarthritis, Knee Arthritis
- Being tested
- Maximal Rate of Force Development Test for Ankle Muscles
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal Rate of Force Development Test for Ankle MusclesDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Maximal Rate of Force Development Test for Ankle Muscles | |
| 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. Receives: Diagnostic Test: Maximal Rate of Force Development Test for Ankle Muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee Osteoarthritis Outcome Score (KOOS)
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.
Measured: Baseline
Forward Step Down Test (FSDT)
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.
Measured: Baseline
Single Leg Hop Test (SLHT)
n this test, participants hop forward as far as possible on one leg, and the distance hopped is recorded.
Measured: Baseline
Isokinetic Testing Procedures
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.
Measured: Baseline
Rate of Force Development (RFD)
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start20 Jul 2023
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Abeer Abdelrahman, Ph.D, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06063889
- Sponsor's protocol ID
- 012/90002023
- Status last verified
- Aug 2024
- First submitted
- 26 Sep 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Maximal Rate of Force Development of Ankle Muscles and Its Association Functional Ability in Patients With Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06063889
- Acronym / sponsor ID
- 012/90002023
- Conditions
- Knee Osteoarthritis, Knee Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 3 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Knee OA Patients | – | Diagnostic Test: Maximal Rate of Force Development Test for Ankle MusclesThis 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. |
| Healthy Control | – | Diagnostic Test: Maximal Rate of Force Development Test for Ankle MusclesThis 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. |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients suffering from knee osteoarthritis.
Key inclusion criteria (6 listed)
- Group 1 (Knee OA group)
- Group 2 (Healthy control group) 1. Individuals with no signs or symptoms of Knee OA or other neurological or musculoskeletal conditions.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximal Rate of Force Development Test for Ankle MusclesThis 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. | Diagnostic test | Healthy Control, Knee OA Patients |
Primary outcome
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abeer Abdelrahman, Ph.D study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Knee Arthritis, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee Osteoarthritis Outcome Score (KOOS) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.