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

Istituto Ortopedico Rizzoli24 enrolled

Overview

"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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Interventions

Sailing Intervention Plus Home-Based TelerehabilitationBEHAVIORAL

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.

Home-Based TelerehabilitationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 30 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals aged 12 to 30 years, of any sex * Clinical and/or molecular diagnosis of a rare skeletal disorder * No orthopedic surgery within the past 6 months, unless deemed clinically irrelevant to study participation by the investigator * Ability to understand and comply with study procedures * Signed informed consent obtained from the participant or a legal guardian (for minors) Exclusion Criteria: * Severe or unstable medical conditions that could interfere with participation (e.g., uncontrolled cardiac or respiratory disease) * Cognitive or neurological impairments that may hinder adherence to the study protocol * Participation in similar intensive rehabilitation programs within the past 3 months * Contraindications to virtual or sailing-based activities, including but not limited to: (a) Severe motion sickness; (b) Vertigo or vestibular disorders; (c) Photosensitive epilepsy * Musculoskeletal injuries (e.g., fractures or major sprains) occurring within the past 12 months * Any condition or circumstance that, in the opinion of the investigator, may compromise safety or study compliance * Decline or inability to provide informed consent

Outcomes

Primary Outcomes

Adherence to Sailing and Home-Based Telerehabilitation

Defined as the percentage of scheduled sessions completed by each participant. Adherence is considered achieved if ≥75% of scheduled sessions are completed. Unit of Measure: Percentage of participants meeting adherence threshold

Time frame: At 6 months after baseline (end of intervention period)

Acceptability of the Intervention

Defined by recruitment rate ≥80% and dropout rate \<20%. Unit of Measure: Recruitment rate (%), Dropout rate (%)

Time frame: At 6 months after baseline (end of intervention period)

Safety of the Intervention

Defined as the absence of serious adverse events related to the intervention. Unit of Measure: Number of participants experiencing a serious adverse event

Time frame: At 6 months after baseline (end of intervention period)

Secondary Outcomes

Change in Motor Function Measured by Inertial Measurement Units

Motor function will be assessed using wearable inertial measurement units (IMUs) to evaluate postural control, gait parameters, upper limb mobility, and proprioception. Data will be collected through standardized physical tasks and analyzed to detect changes over time.