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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
220
Reeducation and readaptation Department
Paris, France
HAQ DI:Health Assessment questionnaire disability index
Health Assessment questionnaire disability index
Time frame: at 12 months
Mac Tar (Mc Master Toronto Arthritis questionnaire)
Mc Master Toronto Arthritis questionnaire
Time frame: at 12 months
S-HAQ ( scleroderma-modified health assessment questionnaire)
Scleroderma-modified health assessment questionnaire
Time frame: at 12 months
SF 36
Time frame: at 12 months
Kapandji modified index
Time frame: at 12 months
Rodnan score
Time frame: at 12 months
Hand Cochin Function Scale
Time frame: at 12 months
Pain
Time frame: at 12 months
Mouth opening
Time frame: at 12 months
Forced expiratory volume (FEV)
Time frame: at 12 months
Satisfaction of clinical condition
Time frame: at 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.