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

March 9, 2026 updated by: Assistance Publique - Hôpitaux de Paris

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75679
        • Reeducation and readaptation Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mac Tar (Mc Master Toronto Arthritis questionnaire)
Time Frame: at 12 months
Mc Master Toronto Arthritis questionnaire
at 12 months
S-HAQ ( scleroderma-modified health assessment questionnaire)
Time Frame: at 12 months
Scleroderma-modified health assessment questionnaire
at 12 months
SF 36
Time Frame: at 12 months
at 12 months
Kapandji modified index
Time Frame: at 12 months
at 12 months
Rodnan score
Time Frame: at 12 months
at 12 months
Hand Cochin Function Scale
Time Frame: at 12 months
at 12 months
Pain
Time Frame: at 12 months
at 12 months
Mouth opening
Time Frame: at 12 months
at 12 months
Forced expiratory volume (FEV)
Time Frame: at 12 months
at 12 months
Satisfaction of clinical condition
Time Frame: at 12 months
at 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

URC-CIC Paris Descartes Necker Cochin

Investigators

  • Study Chair: Serge POIRAUDEAU, MD-PhD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2005

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

April 25, 2006

First Submitted That Met QC Criteria

April 25, 2006

First Posted (Estimated)

April 26, 2006

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOM04023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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