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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00318188
First received: April 25, 2006
Last updated: April 11, 2014
Last verified: April 2014

April 25, 2006
April 11, 2014
September 2005
December 2011   (final data collection date for primary outcome measure)
HAQ DI:Health Assessment questionnaire disability index [ Time Frame: at 12 months ] [ Designated as safety issue: No ]
Health Assessment questionnaire disability index
HAQ DI:Health Assessment questionnaire disability index
Complete list of historical versions of study NCT00318188 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Mac Tar(Mc Master Toronto Arthritis questionnaire)
  • S-HAQ ( scleroderma-modified health assessment questionnaire)
  • SF 36
  • Indices de Kapandji
Not Provided
Not Provided
 
Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Systemic Scleroderma
Procedure: standardized reeducation and readaptation program
  • Experimental: Intervention group
    The patients in this group will do a personalized standardized rehabilitation program on the quality of life.
    Intervention: Procedure: standardized reeducation and readaptation program
  • No Intervention: Control group
    Habitual care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
January 2014
December 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00318188
AOM04023
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Study Chair: Serge POIREAUDEAU, MD-PhD Cochin Hospital
Assistance Publique - Hôpitaux de Paris
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP