Hand ScleroDerma Lived Experience Scale in Individuals with Systemic Sclerosis

• Conditions: Systemic Sclerosis (SSc); Hand Function

• Registration Number: NCT06658483
• Lead Sponsor: Pamukkale University

Brief Summary

The aim of this study was to examine the Turkish validity and reliability of the Hand scleroDerma lived Experience Scale (HAnDE Scale) Questionnaire in individuals with SSc.

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
• Last Update Submitted: 2024-10-24
• Study First Posted: 2024-10-26
• Last Update Posted: 2024-10-26
• Primary Completion: 2025-07-24
• Study Completion: 2025-07-24

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Being diagnosed with Systemic Sclerosis by a rheumatologist
• Being 18 years of age or older,

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hand ScleroDerma Lived Experience Scale (HAnDE Scale) Questionnaire	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.	The scale consists of 18 items regarding the patient-reported status of hand function in individuals with SSc. Each response ranges from 0 to 4. 0 means 'completely disagree' and 4 means 'completely agree'. The higher the scale score, the worse the experience with the hand

Secondary Outcome Measures

Name	Time	Method
Hand Mobility in Scleroderma Test	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.	It is a functional test that evaluates hand mobility. It evaluates 4 specific movements for the hand. These are extension, flexion, finger abduction and wrist dorsal extension. Various objects are used for evaluations, including cutting tool handles, pens, coffee packages, coils of rope, milk packages and tables. Each movement is scored between 0 and 3. 0 is used for being able to perform the movement normally and 3 for being completely unable to perform it. The total score is calculated by adding the scores for each movement and the highest score is 12.
Scleroderma Skin Involvement: Patient-Reported Outcomes	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.	Scleroderma Skin Involvement: Patient-Reported Outcomes was developed to assess skin-related quality of life in patients with systemic sclerosis. SSPRO consists of four domains: physical impact, emotional impact, physical limitation, and social impact, and consists of 18 items in total. Items are rated on a 6-point scale from no disability (0 points) to severe disability (6 points). The scores are added together to calculate a final score (0 to 108 points). A lower score indicates a much better quality of life
Modified Rodnan Skin Thickness Score	Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.	This method used to assess skin thickness in SSc. The Modified Rodnan Skin Thickness Score assesses skin thickness from 17 body regions. A score of 0 indicates normal skin thickness, 1 indicates mild skin thickness, 2 indicates moderate skin thickness, and 3 indicates severe skin thickness; a score of 3 indicates that the skin layers cannot be made between two fingers. The score is calculated by summing the scores from all 17 regions (range 0-51)
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

Trial Locations

Locations (2)

Pamukkale University; 🇹🇷 Denizli, Turkey

Inonu University; 🇹🇷 Malatya, Turkey