Hand ScleroDerma Lived Experience Scale in Individuals With Systemic Sclerosis

March 17, 2026 updated by: Zülal TATAR, Pamukkale University

Investigation of the Turkish Validity and Reliability of the Hand ScleroDerma Lived Experience Scale (HAnDE Scale) Questionnaire in Individuals With Systemic Sclerosis

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.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Observational

Enrollment (Estimated)

54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Denizli, Turkey (Türkiye)
        • Pamukkale University
    • Malatya
      • Malatya, Malatya, Turkey (Türkiye)
        • Inonu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The study will include individuals aged 18 and older who are receiving treatment for Systemic Sclerosis at two university hospital in Turkey, and meet the inclusion and exclusion criteria.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand ScleroDerma Lived Experience Scale (HAnDE Scale) Questionnaire
Time Frame: 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
Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hand Mobility in Scleroderma Test
Time Frame: 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.
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
Time Frame: 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
Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Modified Rodnan Skin Thickness Score
Time Frame: 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)
Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.
Scleroderma Health Assessment Questionnaire
Time Frame: 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
Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pamukkale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2024

Primary Completion (Estimated)

September 24, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Validity and Reliability

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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