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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | The patients in this group will do a personalized standardized rehabilitation program on the quality of life. |
|
| Control group | No Intervention | Habitual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| standardized reeducation and readaptation program | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| HAQ DI:Health Assessment questionnaire disability index | Health Assessment questionnaire disability index | at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mac Tar (Mc Master Toronto Arthritis questionnaire) | Mc Master Toronto Arthritis questionnaire | at 12 months |
| S-HAQ ( scleroderma-modified health assessment questionnaire) | Scleroderma-modified health assessment questionnaire |
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Inclusion Criteria:
Exclusion Criteria :
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| Name | Affiliation | Role |
|---|---|---|
| Serge POIRAUDEAU, MD-PhD | Assistance Publique - Hôpitaux de Paris | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reeducation and readaptation Department | Paris | 75679 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29685482 | Result | 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. | |
| 31219594 |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| D045743 | Scleroderma, Diffuse |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| at 12 months |
| SF 36 | at 12 months |
| Kapandji modified index | at 12 months |
| Rodnan score | at 12 months |
| Hand Cochin Function Scale | at 12 months |
| Pain | at 12 months |
| Mouth opening | at 12 months |
| Forced expiratory volume (FEV) | at 12 months |
| Satisfaction of clinical condition | at 12 months |
| Result |
| Papelard 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. |
| 27696703 | Result | Rannou 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. |