NCT05470790

Brief Summary

Anterior cruciate ligament (ACL) injuries are among the most common knee ligament injuries, causing joint instability and impairments. Besides being challenging, this type of injury greatly affects the athlete's passion and wellbeing, and it is associated with several risk factors. Injuries to the ACL are estimated to occur within 80,000 to 250,000 young, active and healthy athletes each year. This cross-sectional observational study aimed at translating, adapting cross-culturally, and investigating the psychometric properties of the Marx Activity Rating Scale (MARS) and the Knee Stability in Sports/Cutting-Pivoting Ability (KSS/CPA) scale in Saudi patients with anterior cruciate ligament injuries. For this study, a convenient sample size of 100 athletes with ACL injuries and healthy participants will be selected from different Saudi hospitals and clubs. Study participants will be informed about the study and a consent form will be obtained before they participate. A number of scales will be used as outcome measures, including the MARS, KSS/CPA scale, Knee Injury, and Osteoarthritis Outcome Score, Lysholm Knee Score, and International Knee Documentation Committee Subjective Knee Form. Internal consistency of both the MARS and KSS/CPA scales will be tested using Cronbach's alpha. A construct's validity will be measured by Spearman's correlation coefficient. Content validity can be determined by examining whether there are floor and ceiling effects. A significance level of 0.05 will be used to determine whether the data is significant. Ultimately, the study will help patients with ACL injuries to make informed decisions about their treatment, empower healthcare professionals to understand patients' concerns, and facilitate research.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
7mo left

Started May 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
May 2022Dec 2026

Study Start

First participant enrolled

May 1, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 22, 2022

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

4.4 years

First QC Date

July 20, 2022

Last Update Submit

May 11, 2025

Conditions

Keywords

Knee InjurySports AbilityActivity LevelPatient Report OutcomeRating Scales

Outcome Measures

Primary Outcomes (2)

  • Arabic version of Marx activity rating scale

    The arabic version of Marx activity rating scale measures four activities: running, deceleration, cutting, and pivoting; higher scores indicate an increased frequency of knee-related activities. The frequency of performing these activities in the past 12 months is measured on a five-point scale. Based on the four items, the maximum score is 16 (if they answer "four or more times a week" for all four), and the minimum score is zero. For each item, one point will be awarded for each frequency category, beginning with "one time every month." and if participants answered "less than once a month" for one of the items, they will be awarded zero points; "once in a month," one point; "once a week," two points; etc.

    1 minute

  • Arabic version of knee stability in sports/cutting -pivoting ability scale

    The items in the Arabic version of knee stability in sports/cutting -pivoting ability scale are ranked on a Likert scale of 1 to 5, with response categories consisting of (A) normal, (B) near-normal, (C) abnormal, (D) severe abnormal, and (E) dysfunctional. knee stability in sports is a scale that emphasizes giving way to sensations and instability in the knees during linear activities (i.e., running in straight lines, accelerating, and decelerating), which involve lower-level motions. The cutting -pivoting ability scale section concerns the frequency, ability, and discomfort of performing pivotal activities. However, the ordinal knee stability in sports/cutting -pivoting ability scale will be converted into continuous variables (A = 100, B = 75, C = 50, D = 25, E = 0) and an overall self-assessment evaluation of knee function (0 = worst, 100 = best) will be recorded.

    1 minute

Secondary Outcomes (3)

  • Knee Injury and Osteoarthritis Outcome Score

    3 minutes

  • Lysholm Knee Score

    2 minutes

  • International Knee Documentation Committee Subjective Knee Form

    2 minutes

Study Arms (2)

athletes with anterior cruciate ligament injuries

Other: patient reported outcome measures

control

Other: patient reported outcome measures

Interventions

Activity Rating Scale, Knee Stability in Sports/Cutting-Pivoting Ability scale, Knee Injury and Osteoarthritis Outcome Score, Lysholm Knee Score, and International Knee Documentation Committee Subjective Knee Form.

athletes with anterior cruciate ligament injuriescontrol

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

sports population

You may qualify if:

  • An athlete with an orthopedic diagnosis of unilateral ACL injury
  • Age from 18 years to 45 years old
  • Participants who read and write in Arabic
  • Healthy participants that do not have lower limb injury limited participation in physical activity for at least six months.

You may not qualify if:

  • Patients with other lower limbs or different musculoskeletal injuries such as lower back pain may affect physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imam Abdulrahman Bin Faisal University

Dammam, Eastern Province, 2435, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Wounds and InjuriesKnee Injuries

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Leg Injuries

Intervention Hierarchy (Ancestors)

Health Care SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Services ResearchHealth PlanningHealth Care Economics and OrganizationsPatient Outcome AssessmentOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Central Study Contacts

Majed Ali Alabbad, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 20, 2022

First Posted

July 22, 2022

Study Start

May 1, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

IPD will not be shared

Locations