title: Personalized Physical Therapy Versus Usual Care for Patients With Systemic Sclerosis: A Randomized Controlled Trial.
abstract: To compare a physical therapy program to usual care of systemic sclerosis (SSc) patients on disability.
  
  
  
  A 12-month followup, parallel-group randomized controlled trial involving a modified Zelen design was conducted in 4 tertiary-care hospitals. Patients were enrolled if they had a disability rating ≥0.5 on the Health Assessment Questionnaire disability index (HAQ DI) or symptoms of decreased mouth opening or limited range of motion of at least 1 joint. The experimental intervention (n = 112, of which 110 were analyzed) was a 1-month personalized supervised physical therapy program provided by trained care providers followed by home sessions. The comparator (n = 108, and all 108 were analyzed) was usual care that could include ambulatory physical therapy. The primary outcome was the HAQ DI score.
  
  
  
  There was no statistically significant difference in disability at 12 months (HAQ DI score between-group difference -0.01 [95% confidence interval (95% CI) -0.15, 0.13]; P = 0.86). Disability was reduced at 1 month for patients in the physical therapy group (HAQ DI between-group difference -0.14 [95% CI -0.24, -0.03]; P = 0.01); at 6 months the HAQ DI score between-group difference was -0.12 (95% CI -0.23, 0.01); P = 0.054. There was a statistically significant difference for hand mobility and function, and for pain, at 1 month. Microstomia was lower in the physical therapy group at 1, 6, and 12 months (between-group difference at 12 months 1.62 [95% CI 0.32, 2.93]; P = 0.01). No differences in adverse effects were observed.
  
  
  
  A personalized physical therapy program did not reduce disability at 12 months but had short-term benefits for patients with SSc.
authors.affiliation: AP-HP Cochin Hospital, Université Paris Descartes Sorbonne Paris Cité, and INSERM U1153, Paris, France.
authors.forename: François
authors.initials: F
authors.lastname: Rannou
authors.affiliation: AP-HP Hôtel Dieu Hospital, Université Paris Descartes Sorbonne Paris Cité, and INSERM U1153, Paris, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Boutron
authors.affiliation: Reference Center for Rare Diseases, AP-HP Cochin Hospital, and Université Paris Descartes Sorbonne Paris Cité, Paris, France.
authors.forename: Luc
authors.initials: L
authors.lastname: Mouthon
authors.affiliation: AP-HP Cochin Hospital, Université Paris Descartes Sorbonne Paris Cité, and INSERM U1153, Paris, France.
authors.forename: Katherine
authors.initials: K
authors.lastname: Sanchez
authors.affiliation: Reference Center for Rare Diseases, Lille University Medical Center, University of Lille 2, Lille, France.
authors.forename: Vincent
authors.initials: V
authors.lastname: Tiffreau
authors.affiliation: Reference Center for Rare Diseases, Lille University Medical Center, University of Lille 2, Lille, France.
authors.forename: Eric
authors.initials: E
authors.lastname: Hachulla
authors.affiliation: AP-HP Rothschild Hospital and Pierre and Marie Curie University, Paris, France.
authors.forename: Philipe
authors.initials: P
authors.lastname: Thoumie
authors.affiliation: AP-HP Saint-Antoine Hospital and Pierre and Marie Curie University, Paris, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Cabane
authors.affiliation: Hôpital Hautepierre, Fédération de Médecine Translationnelle de Strasbourg, UMR INSERM 1109, Université de Strasbourg-Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
authors.forename: Emmanuel
authors.initials: E
authors.lastname: Chatelus
authors.affiliation: Hôpital Hautepierre, Fédération de Médecine Translationnelle de Strasbourg, UMR INSERM 1109, Université de Strasbourg-Hôpitaux Universitaires de Strasbourg, Strasbourg, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Sibilia
authors.affiliation: AP-HP Cochin Hospital, Université Paris Descartes Sorbonne Paris Cité, and INSERM U1153, Paris, France.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Roren
authors.affiliation: Reference Center for Rare Diseases, AP-HP Cochin Hospital, and Université Paris Descartes Sorbonne Paris Cité, Paris, France.
authors.forename: Alice
authors.initials: A
authors.lastname: Berezne
authors.affiliation: AP-HP Hôtel Dieu Hospital, Université Paris Descartes Sorbonne Paris Cité, and INSERM U1153, Paris, France.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Baron
authors.affiliation: AP-HP Hôtel Dieu Hospital, Université Paris Descartes Sorbonne Paris Cité, and INSERM U1153, Paris, France.
authors.forename: Raphael
authors.initials: R
authors.lastname: Porcher
authors.affiliation: Reference Center for Rare Diseases, AP-HP Cochin Hospital, and Université Paris Descartes Sorbonne Paris Cité, Paris, France.
authors.forename: Loic
authors.initials: L
authors.lastname: Guillevin
authors.affiliation: AP-HP Hôtel Dieu Hospital, Université Paris Descartes Sorbonne Paris Cité, and INSERM U1153, Paris, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
authors.affiliation: AP-HP Cochin Hospital, Université Paris Descartes Sorbonne Paris Cité, and INSERM U1153, Paris, France.
authors.forename: Serge
authors.initials: S
authors.lastname: Poiraudeau
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D005500:Follow-Up Studies; D006699:Home Care Services / Q000592:standards*; D006801:Humans; D008297:Male; D008875:Middle Aged; D005791:Patient Care / Q000379:methods / Q000592:standards; D026741:Physical Therapy Modalities / Q000592:standards*; D057285:Precision Medicine / Q000379:methods / Q000592:standards*; D012595:Scleroderma, Systemic / Q000175:diagnosis* / Q000628:therapy*