NCT06063889

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 20, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 3, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

September 26, 2023

Last Update Submit

August 5, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

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

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

Interventions

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 ControlKnee OA Patients

Eligibility Criteria

Age30 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients suffering from knee osteoarthritis.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Abeer Abdelrahman, Ph.D

    Cairo University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Electromyography lab

Study Record Dates

First Submitted

September 26, 2023

First Posted

October 3, 2023

Study Start

July 20, 2023

Primary Completion

February 2, 2024

Study Completion

February 2, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations