Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2014-01-31

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.

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Detailed Description

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Conditions

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Systemic Scleroderma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Intervention group

The patients in this group will do a personalized standardized rehabilitation program on the quality of life.

Group Type EXPERIMENTAL

standardized reeducation and readaptation program

Intervention Type PROCEDURE

Control group

Habitual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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standardized reeducation and readaptation program

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No