Ready to Sail 2: A Pilot Study of Sail-Assisted Telerehabilitation in Rare Skeletal Diseases

Summary

"Ready to Sail 2 - EXTEND" is a pilot randomized interventional trial designed to assess the feasibility, safety, and preliminary impact of an innovative rehabilitation model combining sailing therapy (velatherapy) with a remote telerehabilitation maintenance program in young individuals with rare skeletal disorders. Building on the promising results of the previous Ready to Sail feasibility study (NCT06397443), this study aims to validate and compare two rehabilitative approaches.

A total of 24 patients aged 12-30 years with a confirmed diagnosis of a rare skeletal disorder will be randomly assigned (1:1) to either:

* Group 1 (Experimental): a 5-day intensive sailing therapy intervention followed by a 3-month personalized telerehabilitation program at home; or
* Group 2 (Active Control): a 3-month telerehabilitation-only program with identical frequency and progression.

The primary objective is to evaluate the feasibility of the experimental program, in terms of adherence, acceptability, and safety. Secondary outcomes include motor functionality (measured by inertial sensors), psychosocial well-being (assessed through validated PROMs), health-related quality of life, and pain perception. The study also explores the medium-term sustainability of rehabilitation outcomes and the influence of individual variables (e.g., age, gender, disease subtype).

The intervention is delivered through a multidisciplinary, patient-centered approach involving rare disease experts, physiatrists, biomechanical engineers, and partner sailing organizations. Sail training activities are adapted for safety and inclusion, and are conducted in two coastal settings (Marina di Ravenna and Palermo), ensuring geographical balance for participant accessibility.

This trial seeks to strengthen the evidence base for integrated, inclusive, and scalable rehabilitation models that address both motor and psychosocial dimensions in rare skeletal conditions.

Conditions

• Rare Bone Disorders

Interventions

BEHAVIORAL

Sailing Intervention Plus Home-Based Telerehabilitation

A two-phase rehabilitation program combining 5 days of intensive sailing therapy with a 3-month home-based telerehabilitation plan. The sailing component includes group-based activities in adapted sailing environments, conducted in Marina di Ravenna or Palermo, with daily debriefing and psychosocial support. The telerehabilitation component includes twice-weekly supervised sessions delivered via a digital platform, focusing on progressive motor, proprioceptive, and postural exercises. The intervention aims to improve motor function, quality of life, and psychosocial well-being in individuals with rare skeletal disorders.

BEHAVIORAL

Home-Based Telerehabilitation

Participants perform a 3-month home-based rehabilitation program consisting of two remote sessions per week via a supervised digital platform. Each session includes warm-up, strength and coordination exercises, and cool-down. Exercises are progressive and standardized, but adapted to individual needs to ensure safety and adherence. The intervention targets motor function, balance, proprioception, and psychosocial outcomes, without any sailing component. This arm serves as the active comparator.

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

30 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-07-15

Primary Completion

2026-03-31

Completion

2026-03-31

Countries

• Italy

Study Locations