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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00318188
First received: April 25, 2006
Last updated: November 23, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention
Systemic Scleroderma
 Procedure: standardized reeducation and readaptation program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effects of a Personalized Standardized Rehabilitation Program on the Quality of Life of Patients With Systemic Sclerosis Patients : a Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • HAQ DI:Health Assessment questionnaire disability index [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Health Assessment questionnaire disability index


Secondary Outcome Measures:
  • Mac Tar (Mc Master Toronto Arthritis questionnaire) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Mc Master Toronto Arthritis questionnaire

  • S-HAQ ( scleroderma-modified health assessment questionnaire) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
    Scleroderma-modified health assessment questionnaire

  • SF 36 [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Kapandji modified index [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Rodnan score [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Hand Cochin Function Scale [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Pain [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Mouth opening [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Forced expiratory volume (FEV) [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
  • Satisfaction of clinical condition [ Time Frame: at 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: September 2005
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00318188

Locations
France
Reeducation and readaptation Department
Paris, France, 75679
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Study Chair: Serge POIREAUDEAU, MD-PhD Cochin Hospital
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00318188     History of Changes
Other Study ID Numbers: AOM04023
Study First Received: April 25, 2006
Last Updated: November 23, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Assistance Publique - Hôpitaux de Paris:
scleroderma
HAQ
Intensive care reeducation, readaptation

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
 Connective Tissue Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013