SCLEREDUC: Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis
Study Details
Study Description
Brief 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. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group The patients in this group will do a personalized standardized rehabilitation program on the quality of life. |
Procedure: standardized reeducation and readaptation program
|
| No Intervention: Control group Habitual care |
Outcome Measures
Primary Outcome Measures
- HAQ DI:Health Assessment questionnaire disability index [at 12 months]
Health Assessment questionnaire disability index
Secondary Outcome Measures
- Mac Tar (Mc Master Toronto Arthritis questionnaire) [at 12 months]
Mc Master Toronto Arthritis questionnaire
- S-HAQ ( scleroderma-modified health assessment questionnaire) [at 12 months]
Scleroderma-modified health assessment questionnaire
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
Exclusion Criteria :
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Reeducation and readaptation Department | Paris | France | 75679 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Study Chair: Serge POIRAUDEAU, MD-PhD, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AOM04023