Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis

Systemic Scleroderma Clinical Trial

— SCLEREDUC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318188
• Other study ID #: AOM04023
• Status: Completed
• Phase: N/A
• First received: April 25, 2006
• Last updated: April 5, 2018
• Start date: September 2005
• Est. completion date: January 2014

Study information

• Verified date: April 2018
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 2014
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Scleroderma

Intervention

Procedure:
• standardized reeducation and readaptation program

Locations

Country	Name	City	State
France	Reeducation and readaptation Department	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

Rannou F, Boutron I, Mouthon L, Sanchez K, Tiffreau V, Hachulla E, Thoumie P, Cabane J, Chatelus E, Sibilia J, Roren A, Berezne A, Baron G, Porcher R, Guillevin L, Ravaud P, Poiraudeau S. Personalized Physical Therapy Versus Usual Care for Patients With S — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAQ DI:Health Assessment questionnaire disability index	Health Assessment questionnaire disability index	at 12 months
Secondary	Mac Tar (Mc Master Toronto Arthritis questionnaire)	Mc Master Toronto Arthritis questionnaire	at 12 months
Secondary	S-HAQ ( scleroderma-modified health assessment questionnaire)	Scleroderma-modified health assessment questionnaire	at 12 months
Secondary	SF 36		at 12 months
Secondary	Kapandji modified index		at 12 months
Secondary	Rodnan score		at 12 months
Secondary	Hand Cochin Function Scale		at 12 months
Secondary	Pain		at 12 months
Secondary	Mouth opening		at 12 months
Secondary	Forced expiratory volume (FEV)		at 12 months
Secondary	Satisfaction of clinical condition		at 12 months