Anterior Cruciate LigamentNCT05470790
Arabic Version of Marx Activity Rating and Knee Stability in Sports/Cutting-Pivoting Ability Scales
An observational study of Anterior Cruciate Ligament and Injuries, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Cruciate Ligament, Injuries
- What is being tested?
- patient reported outcome measures
- How many people
- 150 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 May 2022to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: sports population
Who may be able to join
- 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.
Who cannot join
- 1 Patients with other lower limbs or different musculoskeletal injuries such as lower back pain may affect physical activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Saudi Arabia1 site, 1 recruiting
- Recruiting
Imam Abdulrahman Bin Faisal University
Dammam, Eastern Province, 2435
Fuad Abdulla, PhD, faabdullah@iau.edu.sa
About this study
Official title: Cross-Cultural Adaptation and Psychometric Properties Analysis of Arabic Version of Marx Activity Rating Scale and Knee Stability in Sports/Cutting-Pivoting Ability Scale for Saudi Athletes With Anterior Cruciate Ligament Injury
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.
- Conditions
- Anterior Cruciate Ligament, Injuries
- Being tested
- patient reported outcome measures
- Keywords
- Knee Injury, Sports Ability, Activity Level, Patient Report Outcome, Rating Scales
- Medical subject headings
- Wounds and Injuries, Knee Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient reported outcome measuresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| athletes with anterior cruciate ligament injuries | Not described Receives: Other: patient reported outcome measures | |
| control | Not described Receives: Other: patient reported outcome measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 minute
Secondary outcomes (3)
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.
Measured: 3 minutes
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.
Measured: 2 minutes
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).
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2022
- Study start1 May 2022
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate LigamentStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Collaborators
- Qatif Central Hospital
- Responsible party
- Principal investigator, Majed Ali AlAbbad, Imam Abdulrahman Bin Faisal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05470790
- Sponsor's protocol ID
- QCH-SREC0 4 /2022
- Status last verified
- May 2025
- First submitted
- 20 Jul 2022
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-Cultural Adaptation and Psychometric Properties Analysis of Arabic Version of Marx Activity Rating Scale and Knee Stability in Sports/Cutting-Pivoting Ability Scale for Saudi Athletes With Anterior Cruciate Ligament Injury
- ClinicalTrials.gov ID
- NCT05470790
- Acronym / sponsor ID
- QCH-SREC0 4 /2022
- Conditions
- Anterior Cruciate Ligament, Injuries
- Keywords
- Knee Injury, Sports Ability, Activity Level, Patient Report Outcome, Rating Scales
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Collaborators
- Qatif Central Hospital
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 22 Jul 2022 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| athletes with anterior cruciate ligament injuries | – | Other: patient reported outcome measures |
| control | – | Other: patient reported outcome measures |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- sports population
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 1 Patients with other lower limbs or different musculoskeletal injuries such as lower back pain may affect physical activity
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 |
|---|---|---|
| patient reported outcome measuresActivity 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. | Other | athletes with anterior cruciate ligament injuries, control |
Primary outcome
Arabic version of Marx activity rating scale
Time frame: 1 minute
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.
Arabic version of knee stability in sports/cutting -pivoting ability scale
Time frame: 1 minute
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.
3 secondary outcomes
Knee Injury and Osteoarthritis Outcome Score
Time frame: 3 minutes
Lysholm Knee Score
Time frame: 2 minutes
International Knee Documentation Committee Subjective Knee Form
Time frame: 2 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No. IPD will not be shared
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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.
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 Anterior Cruciate Ligament and Injuries, run by Imam Abdulrahman Bin Faisal University at 1 site in Saudi Arabia.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 14 May 2025. 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 Saudi Arabia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Majed Ali Alabbad, MSc (966569877985, majed2031@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arabic version of Marx activity rating scale (time frame: 1 minute). The study lists 2 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 14 May 2025.