Ignite Creation Date:
2025-12-25 @ 1:41 AM
Ignite Modification Date:
2026-03-12 @ 6:24 AM
Study NCT ID:
NCT06685094
Status:
RECRUITING
Last Update Posted:
2025-11-19
First Post:
2024-11-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translation and Validation of the Upper and Lower Limbs, Pain, Autonomy and Quality of Life Scales in Albanian
Sponsor:
Universidad Católica San Antonio de Murcia
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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).
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).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: