{
  "abstract": "Introduction Rare skeletal disorders (RSDs) cause lifelong functional impairment, chronic pain and reduced quality of life. Evidence-based rehabilitation strategies remain underdeveloped, particularly for adolescents and young adults. We previously demonstrated preliminary feasibility of a 5-day adapted sailing intervention but observed benefit attenuation at 3-month follow-up. This pilot trial evaluates feasibility, acceptability and safety of intensive adapted sailing therapy followed by home-based telerehabilitation maintenance versus telerehabilitation alone.Methods and analysis This is a prospective, randomised, assessor-blinded, parallel two-arm pilot feasibility trial. 24 participants aged 12–30 years with confirmed RSDs will randomise with a 1:1 allocation ratio to: (1) 5-day adapted sailing therapy followed by 3-month telerehabilitation (n=12) or (2) 3-month telerehabilitation alone (n=12). Primary outcomes assess feasibility through recruitment efficiency (≥80% eligible patients enrolled), intervention adherence (≥75% sessions completed), participant retention (≥80% at 6-month follow-up), and safety (zero serious adverse events attributable to interventions). Secondary outcomes include sensor-based motor function (balance, gait, upper extremity mobility via inertial measurement units) and patient-reported outcomes (health-related quality of life, functional capacity, kinesiophobia, pain), measured at baseline, 3-month and 6-month follow-up. Exploratory analyses will estimate preliminary between-group effect sizes. Statistical analysis uses intention-to-treat principles with linear mixed-effects models.Ethics and dissemination The study received approval from the Area Vasta Emilia Centro Ethics Committee (363/2025/Sper/IOR) on 7 July 2025. The study is ongoing, and data collection is expected to be completed by March 2026. Results will be disseminated through peer-reviewed open-access publications, conference presentations, patient organisation partnerships and plain-language summaries.Trial registration number NCT07102875.",
  "authors": [
    {
      "affiliations": [
        "Department of Rare Skeletal Disorders, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Manila Boarini"
    },
    {
      "affiliations": [
        "Department of Rare Skeletal Disorders, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Federico Banchelli"
    },
    {
      "affiliations": [
        "Physics and Astronomy Department (DIFA), Alma Mater Studiorum University, Bologna, Italy"
      ],
      "name": "Davide Scognamiglio"
    },
    {
      "affiliations": [
        "Physical Medicine and Rehabilitation Unit 1, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Giuseppina Mariagrazia Farella"
    },
    {
      "affiliations": [
        "Physical Medicine and Rehabilitation Unit 1, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy",
        "Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy"
      ],
      "name": "Daniela Platano"
    },
    {
      "affiliations": [
        "Physical Medicine and Rehabilitation Unit, Rizzoli-Sicilia Department, IRCCS Istituto Ortopedico Rizzoli, Palermo, Italy"
      ],
      "name": "Serena Rizzo"
    },
    {
      "affiliations": [
        "Independent Practitioner, Bologna, Italy"
      ],
      "name": "Ugo Cavina"
    },
    {
      "affiliations": [
        "Movement Analysis Laboratory, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Giulia Rogati"
    },
    {
      "affiliations": [
        "Movement Analysis Laboratory, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Roberto Ramaglia Amadasi"
    },
    {
      "affiliations": [
        "Euleria srl Società Benefit, Rovereto (Trento), Italy",
        "Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy"
      ],
      "name": "Giacomo Villa"
    },
    {
      "affiliations": [
        "Movement Analysis Laboratory, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Alberto Leardini"
    },
    {
      "affiliations": [
        "Physical Medicine and Rehabilitation Unit 1, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy",
        "Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy"
      ],
      "name": "Lisa Berti"
    },
    {
      "affiliations": [
        "Physical Medicine and Rehabilitation Unit, Rizzoli-Sicilia Department, IRCCS Istituto Ortopedico Rizzoli, Palermo, Italy",
        "Physical Medicine and Rehabilitation Unit 2, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Silvana Sartini"
    },
    {
      "affiliations": [
        "Lega Navale Italiana, Roma, Italy"
      ],
      "name": "Luciano Magnanelli"
    },
    {
      "affiliations": [
        "Ministro per le Disabilità, Roma, Italy"
      ],
      "name": "Alessandra Locatelli"
    },
    {
      "affiliations": [
        "UNIAMO-Federazione Italiana Malattie Rare, Rome, Italy"
      ],
      "name": "Annalisa Maddalena Scopinaro"
    },
    {
      "affiliations": [
        "Department of Rare Skeletal Disorders, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy"
      ],
      "name": "Luca Sangiorgi"
    }
  ],
  "title": "Blended adapted sailing therapy with telerehabilitation for rare skeletal disorders: protocol for a pilot randomised controlled feasibility trial in Italy (PaS2-EXTEND)",
  "uid": "c0ec7ab8-8524-5ea6-af59-a7c420a42f55"
}