Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis

Not Applicable

Completed

• Conditions: Systemic Scleroderma
• Interventions: Procedure: standardized reeducation and readaptation program

• Registration Number: NCT00318188
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2006-04-25
• Study First Submitted QC: 2006-04-25
• Study First Posted: 2006-04-26
• Primary Completion: 2011-12
• Study Completion: 2014-01
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	standardized reeducation and readaptation program	The patients in this group will do a personalized standardized rehabilitation program on the quality of life.

Primary Outcome Measures

Name	Time	Method
HAQ DI:Health Assessment questionnaire disability index	at 12 months	Health Assessment questionnaire disability index

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Reeducation and readaptation Department; 🇫🇷 Paris, France