Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis

NCT00318188 | Completed

• 1 other identifier: AOM04023
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Scleroderma

Keywords

scleroderma; HAQ; Intensive care reeducation, readaptation

Outcome Measures

Primary Outcomes (1)

• HAQ DI:Health Assessment questionnaire disability index

  Health Assessment questionnaire disability index

  at 12 months

Secondary Outcomes (10)

• Mac Tar (Mc Master Toronto Arthritis questionnaire)

  at 12 months

• S-HAQ ( scleroderma-modified health assessment questionnaire)

  at 12 months

• SF 36

  at 12 months

• Kapandji modified index

  at 12 months

• Rodnan score

  at 12 months

Study Arms (2)

Intervention group

EXPERIMENTAL

The patients in this group will do a personalized standardized rehabilitation program on the quality of life.

Procedure: standardized reeducation and readaptation program

Control group

NO INTERVENTION

Habitual care

Interventions

standardized reeducation and readaptation program PROCEDURE

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Associated chronic handicap diseases (stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson's disease, amputated ....)
• Cognitive problems making it impossible to assess the primary outcome measure
• 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.

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Reeducation and readaptation Department

Paris, 75679, France

Location

Related Publications (3)

• Daste C, Rannou F, Mouthon L, Sanchez K, Roren A, Tiffreau V, Hachulla E, Thoumie P, Cabane J, Chatelus E, Sibilia J, Poiraudeau S, Nguyen C. Patient acceptable symptom state and minimal clinically important difference for patient-reported outcomes in systemic sclerosis: A secondary analysis of a randomized controlled trial comparing personalized physical therapy to usual care. Semin Arthritis Rheum. 2019 Feb;48(4):694-700. doi: 10.1016/j.semarthrit.2018.03.013. Epub 2018 Mar 27.

  PMID: 29685482 RESULT

• Papelard A, Daste C, Alami S, Sanchez K, Roren A, Segretin F, Lefevre-Colau MM, Rannou F, Mouthon L, Poiraudeau S, Nguyen C. Construction of an ICF core set and ICF-based questionnaire assessing activities and participation in patients with systemic sclerosis. Rheumatology (Oxford). 2019 Dec 1;58(12):2260-2272. doi: 10.1093/rheumatology/kez209.

  PMID: 31219594 RESULT

• 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 Systemic Sclerosis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2017 Jul;69(7):1050-1059. doi: 10.1002/acr.23098. Epub 2017 Jun 7.

  PMID: 27696703 RESULT

MeSH Terms

Conditions

Scleroderma, Systemic; Scleroderma, Diffuse

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Serge POIRAUDEAU, MD-PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2006
• First Posted: April 26, 2006
• Study Start: September 1, 2005
• Primary Completion: December 1, 2011
• Study Completion: January 1, 2014
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

FR (1)