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Hand ScleroDerma Lived Experience Scale in Individuals With Systemic Sclerosis

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06658483
Enrollment
54
Registered
2024-10-26
Start date
2024-10-24
Completion date
2026-09-30
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hand Function, Systemic Sclerosis (SSc)

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.

Interventions

None listed

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Hand ScleroDerma Lived Experience Scale (HAnDE Scale) QuestionnaireEvaluations 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

MeasureTime frameDescription
Hand Mobility in Scleroderma TestEvaluations 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 OutcomesEvaluations 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 ScoreEvaluations 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 QuestionnaireEvaluations 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

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026