Systemic SclerodermaSCLEREDUCNCT00318188
Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis
A study testing standardized reeducation and readaptation program in people with Systemic Scleroderma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Systemic sclerosis (SSc) is a connective-tissue disease characterized by excessive collagen deposition, vascular hyper-reactivity and obliterative microvascular phenomena leading to disability, handicap, and worsening of quality of life. Pharmacological treatments are mainly used for vascular involvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Scleroderma
- What is being tested?
- standardized reeducation and readaptation program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2005to Jan 2014
- 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
- Men or women aged from 18 years or more, with diagnostic of SSc considering the ACR and/or Leroy and Medsger's criteria.
- HAQ greater than or equal to 0.5
- A perception of limitation of mouth opening and/or at least one limitation in range of motion due to illness
- Good understanding of the French language
Who cannot join
- Associated chronic handicap diseases (stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, amputated ....)
- Any underlying disease that may be incompatible with the management, discovery at the inclusion visit
- Cognitive problems making it impossible to assess the primary outcome measure
- Patients with a standardized rehabilitation program within 6 months prior to inclusion
- Impairment of comprehension or expression of the French language
- Patients participating in another clinical trial or participated in another clinical trial in the previous 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Personalized Standardized Rehabilitation Program on the Quality of Life of Patients With Systemic Sclerosis Patients : a Randomized Controlled Trial
Systemic sclerosis (SSc) is a connective-tissue disease characterized by excessive collagen deposition, vascular hyper-reactivity and obliterative microvascular phenomena leading to disability, handicap, and worsening of quality of life. Pharmacological treatments are mainly used for vascular involvement. To date, no pharmacological treatment have been shown to be effective for the fibrosis leading to skin, tendon, and joint disability. Our hypothesis is that rehabilitation could be an interesting non pharmacological treatment in order to decrease the handicap of SSc patients. Our objective is to evaluate the effect of a personalized standardized rehabilitation program on the quality of life of SSc patients in a multicentric randomized controlled trial. This trial will compare a personalized standardized rehabilitation program to the usual non pharmacological treatment. The primary outcome measure will be the HAQ DI (Health Assessment Questionnaire Disability Index). A Zelen design will be used for this study.
- Conditions
- Systemic Scleroderma
- Being tested
- standardized reeducation and readaptation program
- Keywords
- scleroderma, HAQ, Intensive care reeducation, readaptation
- 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.
standardized reeducation and readaptation programProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The patients in this group will do a personalized standardized rehabilitation program on the quality of life. Receives: Procedure: standardized reeducation and readaptation program |
| Control group | No intervention | Habitual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAQ DI:Health Assessment questionnaire disability index
Health Assessment questionnaire disability index
Measured: at 12 months
Secondary outcomes (10)
Mac Tar (Mc Master Toronto Arthritis questionnaire)
Mc Master Toronto Arthritis questionnaire
Measured: at 12 months
S-HAQ ( scleroderma-modified health assessment questionnaire)
Scleroderma-modified health assessment questionnaire
Measured: at 12 months
SF 36
Measured: at 12 months
Kapandji modified index
Measured: at 12 months
Rodnan score
Measured: at 12 months
Hand Cochin Function Scale
Measured: at 12 months
Pain
Measured: at 12 months
Mouth opening
Measured: at 12 months
Forced expiratory volume (FEV)
Measured: at 12 months
Satisfaction of clinical condition
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2006 (estimated)
- Study startSep 2005
- Primary completionDec 2011
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerodermaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Serge POIRAUDEAU, MD-PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00318188
- Sponsor's protocol ID
- AOM04023
- Acronym
- SCLEREDUC
- Status last verified
- Mar 2026
- First submitted
- 25 Apr 2006
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Daste C, Rannou F, Mouthon L, Sanchez K, Roren A, Tiffreau V, Hachulla E, Thoumie P, Cabane J, Chatelus E, Sibilia J, Poiraudeau S, Nguyen C. Patient acceptable symptom state and minimal clinically important difference for patient-reported outcomes in systemic sclerosis: A secondary analysis of a randomized controlled trial comparing personalized physical therapy to usual care. Semin Arthritis Rheum. 2019 Feb;48(4):694-700. doi: 10.1016/j.semarthrit.2018.03.013. Epub 2018 Mar 27.
PubMed 29685482Papelard A, Daste C, Alami S, Sanchez K, Roren A, Segretin F, Lefevre-Colau MM, Rannou F, Mouthon L, Poiraudeau S, Nguyen C. Construction of an ICF core set and ICF-based questionnaire assessing activities and participation in patients with systemic sclerosis. Rheumatology (Oxford). 2019 Dec 1;58(12):2260-2272. doi: 10.1093/rheumatology/kez209.
PubMed 31219594Rannou F, Boutron I, Mouthon L, Sanchez K, Tiffreau V, Hachulla E, Thoumie P, Cabane J, Chatelus E, Sibilia J, Roren A, Berezne A, Baron G, Porcher R, Guillevin L, Ravaud P, Poiraudeau S. Personalized Physical Therapy Versus Usual Care for Patients With Systemic Sclerosis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1050-1059. doi: 10.1002/acr.23098. Epub 2017 Jun 7.
PubMed 27696703
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Personalized Standardized Rehabilitation Program on the Quality of Life of Patients With Systemic Sclerosis Patients : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00318188
- Acronym / sponsor ID
- SCLEREDUC / AOM04023
- Conditions
- Systemic Scleroderma
- Keywords
- scleroderma, HAQ, Intensive care reeducation, readaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Sep 2005 (actual)
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Apr 2006 (estimated)
- 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 (SSc) is a connective-tissue disease characterized by excessive collagen deposition, vascular hyper-reactivity and obliterative microvascular phenomena leading to disability, handicap, and worsening of quality of life. Pharmacological treatments are mainly used for vascular involvement. To date, no pharmacological treatment have been shown to be effective for the fibrosis leading to skin, tendon, and joint disability. Our hypothesis is that rehabilitation could be an interesting non pharmacological treatment in order to decrease the handicap of SSc patients. Our objective is to evaluate the effect of a personalized standardized rehabilitation program on the quality of life of SSc patients in a multicentric randomized controlled trial. This trial will compare a personalized standardized rehabilitation program to the usual non pharmacological treatment. The primary outcome measure will be the HAQ DI (Health Assessment Questionnaire Disability Index). A Zelen design will be used for this study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: standardized reeducation and readaptation programThe patients in this group will do a personalized standardized rehabilitation program on the quality of life. |
| Control group | No intervention | –Habitual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men or women aged from 18 years or more, with diagnostic of SSc considering the ACR and/or Leroy and Medsger's criteria.
- HAQ greater than or equal to 0.5
- A perception of limitation of mouth opening and/or at least one limitation in range of motion due to illness
- Good understanding of the French language
Key exclusion criteria (6 listed)
- Associated chronic handicap diseases (stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, amputated ....)
- Any underlying disease that may be incompatible with the management, discovery at the inclusion visit
- Cognitive problems making it impossible to assess the primary outcome measure
- Patients with a standardized rehabilitation program within 6 months prior to inclusion
- Impairment of comprehension or expression of the French language
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 |
|---|---|---|
| standardized reeducation and readaptation program | Procedure or surgery | Intervention group |
Primary outcome
HAQ DI:Health Assessment questionnaire disability index
Time frame: at 12 months
Health Assessment questionnaire disability index
10 secondary outcomes
Mac Tar (Mc Master Toronto Arthritis questionnaire)
Time frame: at 12 months
S-HAQ ( scleroderma-modified health assessment questionnaire)
Time frame: at 12 months
SF 36
Time frame: at 12 months
Kapandji modified index
Time frame: at 12 months
Rodnan score
Time frame: at 12 months
Hand Cochin Function Scale
Time frame: at 12 months
Pain
Time frame: at 12 months
Mouth opening
Time frame: at 12 months
Forced expiratory volume (FEV)
Time frame: at 12 months
Satisfaction of clinical condition
Time frame: at 12 months
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 11 Mar 2026.
- Results publication: PubMed 29685482Daste C, Rannou F, Mouthon L, Sanchez K, Roren A, Tiffreau V, Hachulla E, Thoumie P, Cabane J, Chatelus E, Sibilia J, Poiraudeau S, Nguyen C. Patient acceptable symptom state and minimal clinically important difference for patient-reported outcomes in systemic sclerosis: A secondary analysis of a randomized controlled trial comparing personalized physical therapy to usual care. Semin Arthritis Rheum. 2019 Feb;48(4):694-700. doi: 10.1016/j.semarthrit.2018.03.013. Epub 2018 Mar 27.
- Results publication: PubMed 31219594Papelard A, Daste C, Alami S, Sanchez K, Roren A, Segretin F, Lefevre-Colau MM, Rannou F, Mouthon L, Poiraudeau S, Nguyen C. Construction of an ICF core set and ICF-based questionnaire assessing activities and participation in patients with systemic sclerosis. Rheumatology (Oxford). 2019 Dec 1;58(12):2260-2272. doi: 10.1093/rheumatology/kez209.
- Results publication: PubMed 27696703Rannou F, Boutron I, Mouthon L, Sanchez K, Tiffreau V, Hachulla E, Thoumie P, Cabane J, Chatelus E, Sibilia J, Roren A, Berezne A, Baron G, Porcher R, Guillevin L, Ravaud P, Poiraudeau S. Personalized Physical Therapy Versus Usual Care for Patients With Systemic Sclerosis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1050-1059. doi: 10.1002/acr.23098. Epub 2017 Jun 7.
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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.
Serge POIRAUDEAU, MD-PhD study chair
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standardized reeducation and readaptation program in people with Systemic Scleroderma, run by Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 6 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 11 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?
HAQ DI:Health Assessment questionnaire disability index (time frame: at 12 months). 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 NCT00318188, which also lists 3 linked publications.
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 11 Mar 2026.