Clinical trial NCT06685094: Translation and Validation of the Upper and Lower Limbs, Pain, Autonomy and Quality of Life Scales in Albanian
Official title: Cross-cultural Adaptation, Translation and Validation of the Assessment Scales of the Upper and Lower Limbs, Pain, Autonomy and Quality of Life for Use in the Albanian-speaking Population
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Musculoskeletal Pain
Autonomy
Healthy
Upper Limb Injury
Lower Limb Injury
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Albanian patients whom seeking care for articular and muscular pain.

Brief summary: The cross-cultural adaptation will be performed according to the internationally recommended methodology, using the following guidelines: translation, back-translation; revision by a committee, questionnaire diffusion and data collection and analyzing.

The psychometric properties will be evaluated by administering the questionnaire to approximately 300 participants. Reliability will be estimated through stability and homogeneity assessment

Detailed description: The assessment scales of the upper and lower limbs, pain, autonomy and quality of life for use in the Albanian-speaking population are as follow:

1. Adaptation, validation and test-retest reliability of upper limbs scales as: Disabilities of the arm, shoulder and hand questionnaire (DASH), MAYO Elbow score, oxford Elbow score, patent-rated tennis elbow evaluation, shoulder pain and disability index (SPADI), Simple Shoulder Test (SST) and Upper Limp Functional Index (ULFI).
2. Adaptation, validation and test-retest reliability of lower limb scales as: Oxford Hip Score, Motricity Index and Trunk Control Test in Albanian language.
3. Adaptation, validation and test-retest reliability of health scales and autonomy: Berg Balance scale, Functional Ambulation Category (FAC), Fear-Avoidance Beliefs Questionnaire (FABQ), Graded Chronic Pain Scale (GCPS),Motor Assessment Scale (MAS), Stroke rehabilitation Assessment of movement (STREAM), Hospital Anxiety and Depression Scale (HADS), Headache Impact Test (HIT6), Leeds Assessment of Neuropathic Symptoms and Signs pain scale (LANSS), Instrumental activities of daily living scale (IADL), Neck Disability Index (NDI), health status questionnaire (EQ-5D-5L), Social Responsiveness Scale (SRS), short portable mental status questionnaire (SPMSQ), Tampa Skale Kinesiophobia, Ankle--Hindfoot Scale (AOFAS) and the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

Eligibility criteria: Inclusion Criteria:

* articular and muscular pain
* back pain
* presence of rheumatologic symptoms
* functional misbalance
* scoliosis
* musculoskeletal disorders

Exclusion Criteria:

* no native albanian language
* severe trauma to the lumbar spine or hip(s)
* tumor
* metabolic disease

Primary outcomes:
measure: Adaptation, validation and test-retest reliability of upper limbs scales
timeFrame: 7 days
measure: Adaptation, validation and test-retest reliability of lower limb scales
timeFrame: 7 days
measure: Adaptation, validation and test-retest reliability of health scales and autonomy
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
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