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NCT Number: NCT06685094

Translation and Validation of the Limbs, Pain, Autonomy, Depression, Anxiety and Quality of Life Scales in Albanian

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

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Key information

Conditions

Musculoskeletal Pain Arm Injuries Autonomy Healthy Leg Injuries Lower Limb Injury Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Limb Injury Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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:

  • 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).
  • Adaptation, validation and test-retest reliability of lower limb scales as: Oxford Hip Score, Motricity Index and Trunk Control Test in Albanian language.
  • 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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.

  3. Adaptation, validation and test-retest reliability of health scales, depression, anxiety 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).

Sponsors and collaborators

Lead sponsor

Universidad Católica San Antonio de Murcia

Other

Registry information

Official study title

Cross-cultural Adaptation, Translation and Validation of the Assessment Scales of the Upper and Lower Limbs, Pain, Autonomy, Depression, Anxiety and Quality of Life for Use in the Albanian-speaking Population

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Nov 12, 2024
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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