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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00318188
Other study ID # AOM04023
Secondary ID
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
Health authority
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.

Study Design


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
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