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Clinical Trials/NCT06685094
NCT06685094
Recruiting
N/A

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

Universidad Católica San Antonio de Murcia1 site in 1 country300 target enrollmentJune 30, 2025

Overview

Phase
N/A
Intervention
Not specified
Conditions
Musculoskeletal Pain
Sponsor
Universidad Católica San Antonio de Murcia
Enrollment
300
Locations
1
Primary Endpoint
Adaptation, validation and test-retest reliability of upper limbs scales
Status
Recruiting
Last Updated
5 months ago

Overview

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: 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), 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).

Registry
clinicaltrials.gov
Start Date
June 30, 2025
End Date
September 1, 2027
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Universidad Católica San Antonio de Murcia
Responsible Party
Principal Investigator
Principal Investigator

Orges Lena

Principal Investigator

Universidad Católica San Antonio de Murcia

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)
  • metabolic disease

Outcomes

Primary Outcomes

Adaptation, validation and test-retest reliability of upper limbs scales

Time Frame: 7 days

validation of the scales for the: 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).

Adaptation, validation and test-retest reliability of lower limb scales

Time Frame: 7 days

validation of the scales for the: Oxford Hip Score, Motricity Index and Trunk Control Test in Albanian language.

Adaptation, validation and test-retest reliability of health scales and autonomy

Time Frame: 7 days

validation of : 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), 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).

Study Sites (1)

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