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Completed

NCT Number: NCT00318188

Effects of a Personalized Standardized Rehabilitation Program in Systemic Sclerosis

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.

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Key information

Conditions

Systemic Scleroderma Connective Tissue Diseases Scleroderma, Diffuse Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reeducation and readaptation Department

Paris, 75679, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

standardized reeducation and readaptation program

Procedure

Primary outcomes

  1. HAQ DI:Health Assessment questionnaire disability index

    Time frame: at 12 months

    Health Assessment questionnaire disability index

Secondary outcomes

  1. Mac Tar (Mc Master Toronto Arthritis questionnaire)

    Time frame: at 12 months

    Mc Master Toronto Arthritis questionnaire

  2. S-HAQ ( scleroderma-modified health assessment questionnaire)

    Time frame: at 12 months

    Scleroderma-modified health assessment questionnaire

  3. SF 36

    Time frame: at 12 months

  4. Kapandji modified index

    Time frame: at 12 months

  5. Rodnan score

    Time frame: at 12 months

  6. Hand Cochin Function Scale

    Time frame: at 12 months

  7. Pain

    Time frame: at 12 months

  8. Mouth opening

    Time frame: at 12 months

  9. Forced expiratory volume (FEV)

    Time frame: at 12 months

  10. Satisfaction of clinical condition

    Time frame: at 12 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: SCLEREDUC

Important dates

Study start
2005
Primary completion
2011
Study completion
2014
First posted
Apr 26, 2006
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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