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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06063889
Other study ID # 012/90002023
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 20, 2023
Est. completion date October 2, 2023

Study information

Verified date September 2023
Source Ahram Canadian University
Contact Mohamed ElMeligie, Ph.D
Phone +201064442032
Email mohamed.elmeligie@acu.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 126
Est. completion date October 2, 2023
Est. primary completion date October 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Years to 45 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Egypt Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al ?ayy Ath Thamin Giza

Sponsors (1)

Lead Sponsor Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Baseline
Primary 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. Baseline
Primary Single Leg Hop Test (SLHT) n this test, participants hop forward as far as possible on one leg, and the distance hopped is recorded. Baseline
Primary 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. Baseline
Primary 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. Baseline
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