Hand Disability in Systemic Sclerosis - Digital Ulcers

• Conditions: Systemic Sclerosis (SSc); Digital Ulcer

• Registration Number: NCT06658470
• Lead Sponsor: Pamukkale University

Brief Summary

The aim of this study was to examine the Turkish validity and reliability of the Hand Disability in Systemic Sclerosis - Digital Ulcers Questionnaire (HDISS-DU) in individuals with Systemic Sclerosis.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-24
• Study First Submitted: 2024-10-24
• Study First Submitted QC: 2024-10-24
• Study First Posted: 2024-10-26
• Last Update Submitted: 2024-11-18
• Last Update Posted: 2024-11-19
• Primary Completion: 2025-04-24
• Study Completion: 2025-04-24

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Diagnosed with SSc by a rheumatologist
• Being 18 years of age or older

Exclusion Criteria

• Presence of neurological disease
• Presence of any orthopedic problem that would affect functionality
• Presence of a history of orthopedic surgery
• Inability to speak or understand Turkish fluently
• Presence of a psychiatric disease that would affect cooperation
• Severe neurological disease that would affect hand functions (peripheral nerve lesion, trauma, operation, cerebrovascular accident)
• Heart failure and lung pathology that would affect daily living activities

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Hand Disability in Systemic Sclerosis-Digital Ulcers Questionnaire	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.	It was developed to evaluate the disability caused by digital ulcers in the hand in patients with Systemic Sclerosis. It consists of 24 questions. There are 8 response options. Responses are scored from 1 to 6. 1 'yes, without difficulty'; 2 'yes, with very little difficulty', 3 'yes, with some difficulty', 4 'yes, with great difficulty', 5 'almost impossible' and 'using only the unaffected hand' (same score for both responses) and 6 'impossible'. The eighth response option 'did not do this activity in the last 7 days' is not included in the scoring. The total HDISS-DU score is calculated as the average of the scores of the questions where the eighth option was not given as an answer (threshold for questions with an eighth answer \<12 questions). The total score ranges from a minimum of 1 point to a maximum of 6 points.

Secondary Outcome Measures

Name	Time	Method
Scleroderma Health Assessment Questionnaire	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.	Used to assess disease activity. It has 20 items in 8 sections assessing physical disability. In addition, Raynaud phenomenon, digital ulcers, pulmonary and gastrointestinal symptoms are assessed according to the Visual Analog Scale, which is scored between "0" and "10". VAS is scored between 0 and 3 by multiplying by 0.2
Cochin 17-Item Scleroderma Functional Scale	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.	The scle assesses activity and participation in patients with systemic sclerosis. It consists of 17 items and two sections: Section A (10 items, factor 1) assesses mobility. Section B (7 items, factor 2) assesses general tasks and demands. The score for each section is the sum of the scores for each item: Section A scores range from 0 to 100, and Section B scores range from 0 to 70. The total score for the Cochin 17-Item Scleroderma Functional Scale is defined as the sum of the scores for each section and ranges from 0 (no limitation) to 170 (maximum limitation).

Trial Locations

Locations (2)

Pamukkale University; 🇹🇷 Denizli, Malatya, Turkey

Inonu University; 🇹🇷 Malatya, Turkey