Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Effects of a Personalized Standardized Rehabilitation Program on the Quality of Life of Patients With Systemic Sclerosis Patients : a Randomized Controlled Trial

Conditions
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Systemic Scleroderma

Intervention / Treatment
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* Procedure: standardized reeducation and readaptation program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>The patients in this group will do a personalized standardized rehabilitation program on the quality of life. | Procedure: standardized reeducation and readaptation program<br> <br> |
| No Intervention: Control group<br>Habitual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAQ DI:Health Assessment questionnaire disability index | Health Assessment questionnaire disability index | at 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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scleroderma, HAQ, Intensive care reeducation, readaptation