Ready to Sail 2: A Pilot Study of Sail-Assisted Telerehabilitation in Rare Skeletal Diseases (PaS2-EXTEND)

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Rare Bone Disorders

Treatments: Behavioral: Home-Based Telerehabilitation; Behavioral: Sailing Intervention Plus Home-Based Telerehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT07102875

363/2025/Sper/IOR

Details and patient eligibility

About

"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.

Enrollment: 24 estimated patients

Sex: All

Ages: 12 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Sailing Intervention Followed by Home-Based Telerehabilitation Program

Experimental group

Description:

Participants assigned to this arm will receive a 5-day intensive sailing intervention program, followed by a 3-month home-based telerehabilitation program. The sailing includes daily group-based sailing activities and debriefing activities aimed at enhancing motor skills, coordination, and psychosocial well-being. After the sailing phase, participants will engage in remote physical therapy sessions twice a week via a supervised digital platform. The telerehabilitation component includes progressive exercises targeting balance, proprioception, and functional strength.

Treatment:

Behavioral: Sailing Intervention Plus Home-Based Telerehabilitation

Home-Based Telerehabilitation Program

Active Comparator group

Description:

Participants in this arm will undergo a 3-month home-based telerehabilitation program. The intervention consists of two weekly remote sessions conducted via an accredited digital platform. Each session includes warm-up, structured motor and postural exercises, and cool-down/stretching phases. Exercises are progressive and tailored to individual functional capacities, with the goal of improving balance, coordination, and physical function. No sailing therapy is included in this arm.

Treatment:

Behavioral: Home-Based Telerehabilitation