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

Not Applicable

Recruiting

• Conditions: Rare Bone Disorders

• Registration Number: NCT07102875
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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 10 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 (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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-14
• Study Start: 2025-07-16
• Study First Submitted QC: 2025-07-28
• Last Update Submitted: 2025-07-28
• Study First Posted: 2025-08-05
• Last Update Posted: 2025-08-05
• Primary Completion: 2026-03
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility of a Combined Sailing and Home-Based Telerehabilitation Program	At 3 months after baseline (end of intervention period)	Feasibility will be assessed through three core indicators: (1) Adherence, defined as completion of ≥75% of scheduled sessions; (2) Acceptability, defined by recruitment rate ≥80% and dropout rate \<20%; (3) Safety, based on the absence of serious adverse events related to the intervention. These indicators align with international standards for pilot studies in rare disease rehabilitation.

Secondary Outcome Measures

Name	Time	Method
Change in Motor Function Measured by Inertial Measurement Units	Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), and at 3-Month Follow-Up (T2)	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.
Change in Health-Related Quality of Life Measured by EQ-5D-5L	Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), and at 3-Month Follow-Up (T2)	Health-related quality of life will be measured using the EQ-5D-5L questionnaire, including both index score and EQ Visual Analog Scale (EQ-VAS). The tool assesses mobility, self-care, usual activities, pain/discomfort, and anxiety/depression on a 5-level scale.
Change in Psychosocial Functioning Measured by BESSI-45	Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), and at 3-Month Follow-Up (T2)	Psychosocial functioning will be assessed with the Behavioral, Emotional, and Social Skills Inventory (BESSI-45), which evaluates competencies across five domains: emotional, social, collaborative, creative, and self-regulatory skills.
Change in Functional Outcomes Measured by PODCI	Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), and at 3-Month Follow-Up (T2)	Functional health outcomes will be assessed using the Pediatric Outcomes Data Collection Instrument (PODCI), which includes domains such as upper extremity function, mobility, sports and physical activity, pain, happiness, and global function.
Change in Pain Intensity Measured by Visual Analogue Scale (VAS)	Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), and at 3-Month Follow-Up (T2)	Pain intensity will be assessed using a 10 cm Visual Analogue Scale (VAS), where participants indicate current pain level from "no pain" to "worst pain imaginable." The tool is sensitive to changes over time in musculoskeletal conditions.
Change in Kinesiophobia Measured by Tampa Scale for Kinesiophobia (TSK)	Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), and at 3-Month Follow-Up (T2)	Fear of movement will be measured using the 13-item Tampa Scale for Kinesiophobia (TSK), assessing fear-avoidance beliefs, catastrophic thinking, and perception of vulnerability to pain or injury due to movement.

Trial Locations

Locations (1)

IRCCS Istituto Ortopedico Rizzoli; 🇮🇹 Bologna, Italy