Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.
SCLERO-HAND
Scleroderma: Description of Functional Disability Between the Dominant and Contralateral Hand, a Single-centre Descriptive Cohort.
1 other identifier
interventional
30
1 country
1
Brief Summary
Systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. Management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. The aim of this study is to describe and compare the average spontaneous and attempted reduction range of motion limitations between the dominant and contralateral hand.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2021
CompletedFirst Posted
Study publicly available on registry
December 28, 2021
CompletedStudy Start
First participant enrolled
December 28, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2022
CompletedMarch 27, 2026
May 1, 2022
4 months
November 29, 2021
March 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Measurement of joint amplitudes
Measurement of joint amplitudes by goniometry
at inclusion
Secondary Outcomes (6)
Digital skin score
at inclusion
Digital pressure
at inclusion
Number of digital ulcers
at inclusion
Number of subcutaneous calcifications
at inclusion
Visual Analog Score for pain
at inclusion
- +1 more secondary outcomes
Study Arms (2)
moderate Scleroderma
EXPERIMENTALPatients with Cochin hand score less than or equal to 16
severe Scleroderma
EXPERIMENTALPatients with Cochin hand score greater than 16
Interventions
Measurement of joint amplitudes by goniometry of the MCP, IPP, IPD for 2, 3, 4 and 5th radii, 1st commissure spacing and Kapandji score for the thumb
Eligibility Criteria
You may qualify if:
- Group 1 :
- Major patient
- Diagnosis of diffuse or limited cutaneous systemic sclerosis according to the new ACR/EULAR criteria
- Cochin hand score less than or equal to 16
- Group 2 :
- Major patient
- Diagnosis of diffuse or limited cutaneous systemic sclerosis according to the new ACR/EULAR criteria
- Cochin hand score greater than 16.
You may not qualify if:
- Overlap syndrome (Sharp or scleromyositis 2)
- Patient with another autoimmune disease
- History of surgery or trauma to the hand with proven functional sequelae
- Presence of synovitis
- Patient with Dupuytren's disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Limoges
Limoges, 87042, France
Related Publications (1)
Fourmond S, Parreau S, Dumonteil S, Verdie-Kessler C, Ly KH, Lacroix P, Fauchais AL, Bernard P, Palat S. The functional disabilities of the dominant and opposite hands in patients with systemic sclerosis. Clin Exp Rheumatol. 2024 Aug;42(8):1665-1668. doi: 10.55563/clinexprheumatol/db7upl. Epub 2024 Mar 19.
PMID: 38526006RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2021
First Posted
December 28, 2021
Study Start
December 28, 2021
Primary Completion
April 22, 2022
Study Completion
April 22, 2022
Last Updated
March 27, 2026
Record last verified: 2022-05