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NCT Number: NCT06658483

Hand ScleroDerma Lived Experience Scale 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.

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Key information

Conditions

Systemic Sclerosis (SSc) Connective Tissue Diseases Hand Function Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Inonu University, Malatya, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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)

  4. 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

Sponsors and collaborators

Lead sponsor

Pamukkale University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 26, 2024
Registry last updated
Mar 19, 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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