Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05470790
Other study ID # QCH-SREC0 4 /2022
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 1, 2022
Est. completion date December 1, 2025

Study information

Verified date March 2024
Source Imam Abdulrahman Bin Faisal University
Contact Majed Ali Alabbad, MSc
Phone 966569877985
Email majed2031@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 1, 2025
Est. primary completion date October 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: 1. An athlete with an orthopedic diagnosis of unilateral ACL injury 2. Age from 18 years to 45 years old 3. Participants who read and write in Arabic 4. Healthy participants that do not have lower limb injury limited participation in physical activity for at least six months. Exclusion Criteria: - 1 Patients with other lower limbs or different musculoskeletal injuries such as lower back pain may affect physical activity

Study Design


Related Conditions & MeSH terms


Intervention

Other:
patient reported outcome measures
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.

Locations

Country Name City State
Saudi Arabia Imam Abdulrahman Bin Faisal University Dammam Eastern Province

Sponsors (2)

Lead Sponsor Collaborator
Imam Abdulrahman Bin Faisal University Qatif Central Hospital

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Knee Injury and Osteoarthritis Outcome Score There are five subscales with 42 items in the Knee Injury and Osteoarthritis Outcome Score questionnaire: Pain (9 items), Symptoms (7 items), Activities of Daily Living (17 items), Sport and Recreation (5 items), and Knee-related Quality of Life (QoL4). Each item wil be scored using a Likert scale ranging from 0 (no problem) to 4 (extreme problem). In addition, the subscale items will be rated on a scale of 0 to 100 using the following formula (100*average of subscale item scores/4*100), and higher scores indicate better health (100 = no knee problems) while low scores indicate poor health. 3 minutes
Secondary Lysholm Knee Score Eight categories will be measured in the Lysholm Knee Score: instability (25 marks), pain (25 marks), catching (15 marks), stair climbing (10 marks), swelling (10 marks), need for support (5 marks), squatting (5 marks), and limping (5 marks). Each answer to the eight questions counts toward the total score, ranging from 0 to 100. High scores indicate better results and fewer symptoms. Lower scores indicate a problem with knee function. 2 minutes
Secondary International Knee Documentation Committee Subjective Knee Form There are three main sections in the International Knee Documentation Committee Subjective Knee Form, overall consisting of 18 items: (1) symptoms (7 items), including swelling, pain, stiffness, giving way, and locking, (2) sports (1 item), (3) current knee function (9 items), and knee function after a knee injury (1 item) (not included in the overall score). The International Knee Documentation Committee Subjective Knee Form will be calculated by adding the scores of the individual items. The score will be then transformed into an overall score ranging from 0 to 100, with 100 indicating the absence of symptoms and higher levels of functioning. A total score of 100 will be calculated as (sum of items)/ (maximum possible score). 2 minutes
See also
  Status Clinical Trial Phase
Completed NCT03285009 - Movement Patterns in Young Volleyball Athletes N/A
Recruiting NCT05487768 - Functional Connectivity After Anterior Cruciate Ligament Reconstruction N/A
Not yet recruiting NCT06195631 - Evaluating a Standardized Checklist Bundle for Optimizing Procedural Ergonomics in Endoscopy N/A
Completed NCT02329340 - Safety Skills Training: Parents of School-Aged Children Phase 2
Not yet recruiting NCT05529017 - Post Injury Performance Deficits in Rink Hockey
Recruiting NCT05910515 - Improving Performance in Pediatric Trauma by Teaching Nontechnical Skills N/A
Completed NCT04096196 - A Game-based Educational Approach to Promote Child Safety Knowledge and Behaviours N/A
Completed NCT06264323 - Incidence of Acute Injuries in Boxing
Completed NCT06039358 - Effects of Caffeine Ingestion on the Biomechanics of Healthy Young Subjects N/A
Recruiting NCT05394363 - Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents
Recruiting NCT06092866 - Digital Versus Telephone Symptom Assessment and Triage in Primary Care N/A
Not yet recruiting NCT05549830 - Effect of Different Positioning Before, During and After Surgery on Pressure Injury N/A
Active, not recruiting NCT00852085 - Reducing Youthful Dangerous Driving Phase 1/Phase 2
Completed NCT05552430 - Virtual Reality for Pain in Acute Orthopedic Injuries N/A
Not yet recruiting NCT06302088 - The Safety Integration Stakeholders (SAINTS) Program to Integrate Worker and Patient Safety in Oregon Rural Hospitals N/A
Recruiting NCT03517475 - Tailoring a Home Supervision Intervention for Low-Income Families N/A
Completed NCT03108820 - Trauma Medical Home for Older Injured Patients N/A
Active, not recruiting NCT05629156 - Injury and Illness Surveillance at the FIFA World Cup Qatar 2022TM
Completed NCT05121649 - Video-instructed First Aid in Emergency Medical Call Centers
Active, not recruiting NCT04469036 - Improving Family-Centered Pediatric Trauma Care: The Standard of Care Versus the Virtual Pediatric Trauma Center N/A