Clinical trial NCT04909099: Arabic Version of the EARS Questionnaire
Official title: Cross-cultural Adaptation and Psychometric Properties of the Arabic Version of the Exercise Adherence Rating Scale
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Low Back Pain
Lead sponsor: Prince Sultan Military College of Health Sciences
Sponsor class: OTHER
Collaborators: name: King Fahd Military Medical Complex
First posted: 2021-06-01
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential participants will be recruited from patients with chronic low back pain (CLBP) or knee osteoarthritis referred to the outpatient physical therapy services of the local medical facilities.

Brief summary: A study to translate and cross-culturally adapt the Exercise Adherence Rating Scale (EARS) into the Arabic language, and assess its psychometric properties.


Eligibility criteria: Inclusion Criteria:

* Low back pain patients: aged 18 years or older, experienced non-specific CLBP of 3 months or longer, pain localized to the lumbar region.
* Knee OA patients: eligible participants must meet the knee OA diagnostic criteria according to the American College of Rheumatology (ACR).

Exclusion Criteria:

* degenerative systemic diseases
* neurological symptoms
* lumbar stenosis
* spondylolisthesis
* history of spinal or knee surgeries
* pregnancy
* rheumatoid arthritis
* serious pathological conditions (inflammatory arthritis and malignancy)
* individuals who cannot read and understand documents written in the Arabic language.

Primary outcomes:
measure: Floor and ceiling effect
timeFrame: 1 day
measure: Content Validity
timeFrame: 1 day
measure: Construct Validity
timeFrame: 1 day
measure: Internal Consistency
timeFrame: 3-7 days
measure: Test-retest Reliability
timeFrame: 3-7 days
Secondary outcomes:
measure: Responsiveness
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Dhahran
country: Saudi Arabia
facility: King Fahd Military Medical Complex
state: Eastern Province
Study officials:
affiliation: Cairo University
name: Ahmed Farrag, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.
citation: Meade LB, Bearne LM, Godfrey EL. Comprehension and face validity of the Exercise Adherence Rating Scale in patients with persistent musculoskeletal pain. Musculoskeletal Care. 2018 Sep;16(3):409-412. doi: 10.1002/msc.1240. Epub 2018 Mar 25. No abstract available.
citation: Terwee CB, Bot SD, de Boer MR, van der Windt DA, Knol DL, Dekker J, Bouter LM, de Vet HC. Quality criteria were proposed for measurement properties of health status questionnaires. J Clin Epidemiol. 2007 Jan;60(1):34-42. doi: 10.1016/j.jclinepi.2006.03.012. Epub 2006 Aug 24.
citation: Newman-Beinart NA, Norton S, Dowling D, Gavriloff D, Vari C, Weinman JA, Godfrey EL. The development and initial psychometric evaluation of a measure assessing adherence to prescribed exercise: the Exercise Adherence Rating Scale (EARS). Physiotherapy. 2017 Jun;103(2):180-185. doi: 10.1016/j.physio.2016.11.001. Epub 2016 Nov 9.
citation: de Lira MR, de Oliveira AS, Franca RA, Pereira AC, Godfrey EL, Chaves TC. The Brazilian Portuguese version of the Exercise Adherence Rating Scale (EARS-Br) showed acceptable reliability, validity and responsiveness in chronic low back pain. BMC Musculoskelet Disord. 2020 May 12;21(1):294. doi: 10.1186/s12891-020-03308-z.