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Systemic Sclerosis (SSc)NCT06658483

Hand ScleroDerma Lived Experience Scale in Individuals With Systemic Sclerosis

An observational study of Systemic Sclerosis (SSc) and Hand Function, run by Pamukkale University at 2 sites in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Systemic Sclerosis (SSc), Hand Function
How many people
54 participants
Where
2 sitesTurkey (Türkiye)
Study dates
24 Oct 2024to 30 Sep 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)2 sites

  • Pamukkale University

    Denizli

  • Inonu University

    Malatya, Malatya

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Medical subject headings
Scleroderma, Systemic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hand ScleroDerma Lived Experience Scale (HAnDE Scale) Questionnaire

    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

    Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Secondary outcomes (4)

  1. Hand Mobility in Scleroderma Test

    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.

    Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

  2. Scleroderma Skin Involvement: Patient-Reported Outcomes

    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

    Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

  3. Modified Rodnan Skin Thickness Score

    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)

    Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

  4. Scleroderma Health Assessment Questionnaire

    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

    Measured: Evaluations started immediately after receiving ethics committee approval and will be completed within 6 months, which is the study period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2024
  2. Study start24 Oct 2024
  3. Primary completion24 Sep 2026 (estimated)
  4. Study completion30 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06658483
Sponsor's protocol ID
Validity and Reliability
Status last verified
Mar 2026
First submitted
24 Oct 2024
Last updated
19 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Systemic Sclerosis (SSc) and Hand Function, run by Pamukkale University at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06658483.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

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