Scleroderma, SystemicSCLERO-HANDNCT05171114
Scleroderma: Functional Disability Between the Dominant and Contralateral Hand.
A study testing Measurement of joint amplitudes in people with Scleroderma, Systemic, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Scleroderma, Systemic
- What is being tested?
- Measurement of joint amplitudes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 28 Dec 2021to 22 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Scleroderma, Systemic
- Being tested
- Measurement of joint amplitudes
- Keywords
- scleroderma, dermatology
- Medical subject headings
- Scleroderma, Systemic, Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of joint amplitudesDiagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| moderate Scleroderma | Experimental | Patients with Cochin hand score less than or equal to 16 Receives: Diagnostic Test: Measurement of joint amplitudes |
| severe Scleroderma | Experimental | Patients with Cochin hand score greater than 16 Receives: Diagnostic Test: Measurement of joint amplitudes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of joint amplitudes
Measurement of joint amplitudes by goniometry
Measured: at inclusion
Secondary outcomes (6)
Digital skin score
Measure with modified Rodnan skin score. The value of this score varies from 0 (no cuntaneous sclerosis) to 51(severe cutaneous sclerosis).
Measured: at inclusion
Digital pressure
use of Finger Systolic Blood Pressure Index (FBPI) proposed by Blaise et al.
Measured: at inclusion
Number of digital ulcers
Measured: at inclusion
Number of subcutaneous calcifications
Measured: at inclusion
Visual Analog Score for pain
Score varie from 0 (no pain) to 10 (worst pain possible)
Measured: at inclusion
number of painful joints
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start28 Dec 2021
- Primary completion22 Apr 2022
- Study completion22 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Prospective, descriptive and comparative, monocentric pilot study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171114
- Sponsor's protocol ID
- 87RI21_0029
- Acronym
- SCLERO-HAND
- Status last verified
- May 2022
- First submitted
- 29 Nov 2021
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38526006
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scleroderma: Description of Functional Disability Between the Dominant and Contralateral Hand, a Single-centre Descriptive Cohort.
- ClinicalTrials.gov ID
- NCT05171114
- Acronym / sponsor ID
- SCLERO-HAND / 87RI21_0029
- Conditions
- Scleroderma, Systemic
- Keywords
- scleroderma, dermatology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 28 Dec 2021 (actual)
- Primary completion
- 22 Apr 2022 (actual)
- Study completion
- 22 Apr 2022 (actual)
- First posted
- 28 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, descriptive and comparative, monocentric pilot study
| Arm | Type | Receives |
|---|---|---|
| moderate Scleroderma | Experimental | Diagnostic Test: Measurement of joint amplitudesPatients with Cochin hand score less than or equal to 16 |
| severe Scleroderma | Experimental | Diagnostic Test: Measurement of joint amplitudesPatients with Cochin hand score greater than 16 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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 :
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of joint amplitudesMeasurement 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 | Diagnostic test | moderate Scleroderma, severe Scleroderma |
Primary outcome
Measurement of joint amplitudes
Time frame: at inclusion
Measurement of joint amplitudes by goniometry
6 secondary outcomes
Digital skin score
Time frame: at inclusion
Digital pressure
Time frame: at inclusion
Number of digital ulcers
Time frame: at inclusion
Number of subcutaneous calcifications
Time frame: at inclusion
Visual Analog Score for pain
Time frame: at inclusion
number of painful joints
Time frame: at inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Results publication: PubMed 38526006Fourmond 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measurement of joint amplitudes in people with Scleroderma, Systemic, run by University Hospital, Limoges at 1 site in France.
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 8 inclusion and 5 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: finished, as of the sponsor's last update on 27 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 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measurement of joint amplitudes (time frame: at inclusion). 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 NCT05171114, which also lists 1 linked publication.
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 27 Mar 2026.