Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis (SCLEREDUC)

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Systemic Scleroderma

Treatments

Procedure: standardized reeducation and readaptation program

Study type

Interventional

Funder types

Other

Identifiers

NCT00318188

AOM04023

Details and patient eligibility

About

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.

Enrollment

220 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.