Scleroderma: Functional Disability Between the Dominant and Contralateral Hand. (SCLERO-HAND)

March 24, 2026 updated by: University Hospital, Limoges

Scleroderma: Description of Functional Disability Between the Dominant and Contralateral Hand, a Single-centre Descriptive Cohort.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Systemic sclerosis is an autoimmune disease in which the hand is responsible for 75% of the overall disability. In case of limitation, the level of skin fibrosis, Raynaud's syndrome and its complications, the search for painful joints with or without synovitis, and the presence of calcifications must therefore be assessed. Management is based on systemic treatments combined with kinesitherapy aimed at maintaining joint amplitudes, improving muscle strength and preventing stiffness. No study to date has compared the functionality of one hand to the other. The hypothesis is that there is a difference in range of motion limitations between the dominant hand and the contralateral hand.

Patients in the active file of the Internal Medicine A department of the Limoges University Hospital who meet the inclusion criteria will be offered the study by telephone. Patients wishing to participate will be given an appointment on a dedicated consultation slot. During this visit, Patients will be given an information note and their consent will be collected. The study examinations will be performed and the questionnaire completed. At the end of this visit, the study will be completed for the patient.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • France
      • Limoges, France, 87042
        • CHU de Limoges

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: moderate Scleroderma
Patients with Cochin hand score less than or equal to 16
Diagnostic test: Measurement of joint amplitudes
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
Experimental: severe Scleroderma
Patients with Cochin hand score greater than 16
Diagnostic test: Measurement of joint amplitudes
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of joint amplitudes
Time Frame: at inclusion
Measurement of joint amplitudes by goniometry
at inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Digital skin score
Time Frame: at inclusion
Measure with modified Rodnan skin score. The value of this score varies from 0 (no cuntaneous sclerosis) to 51(severe cutaneous sclerosis).
at inclusion
Digital pressure
Time Frame: at inclusion
use of Finger Systolic Blood Pressure Index (FBPI) proposed by Blaise et al.
at inclusion
Number of digital ulcers
Time Frame: at inclusion
at inclusion
Number of subcutaneous calcifications
Time Frame: at inclusion
at inclusion
Visual Analog Score for pain
Time Frame: at inclusion
Score varie from 0 (no pain) to 10 (worst pain possible)
at inclusion
number of painful joints
Time Frame: at inclusion
at inclusion

Collaborators and Investigators

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

Sponsor

University Hospital, Limoges

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 28, 2021

Primary Completion (Actual)

April 22, 2022

Study Completion (Actual)

April 22, 2022

Study Registration Dates

First Submitted

November 29, 2021

First Submitted That Met QC Criteria

December 10, 2021

First Posted (Actual)

December 28, 2021

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 87RI21_0029

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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