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NCT Number: NCT07102875

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

"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.

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Key information

Conditions

Rare Bone Disorders Behavior Disease Attributes Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Personal Satisfaction Psychological Well-Being Rare Diseases Social Behavior

Age range

12 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy, 40136

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals aged 12 to 30 years, of any sex
  • Clinical and/or molecular genetic diagnosis of RSD per Orphanet classification
  • 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

Treatment and study plan

Sailing Intervention Plus Home-Based Telerehabilitation

Behavioral

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.

Other names: 5-day sailing activity

Home-Based Telerehabilitation

Behavioral

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.

Primary outcomes

  1. Adherence to Sailing and Home-Based Telerehabilitation

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

    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

  2. Acceptability of the Intervention

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

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

  3. Safety of the Intervention

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

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

Secondary outcomes

  1. Change in Motor Function Measured by Inertial Measurement Units

    Time frame: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)

    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.

  2. Change in Health-Related Quality of Life Measured by EQ-5D-5L

    Time frame: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)

    Health-related quality of life will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. This instrument includes:

    • EQ-5D-5L Index Value, ranging from -0.232 to 1.000 (where 1.000 indicates full health, 0 indicates death-equivalent health, and negative values represent health states considered worse than death; higher scores indicate better health status).
    • EQ Visual Analog Scale (EQ-VAS), ranging from 0 to 100, where 0 represents the "worst imaginable health state" and 100 represents the "best imaginable health state." Higher scores indicate better self-rated health.

    Unit of Measure: EQ-5D-5L Index Value (-0.281 to 1.000); EQ-VAS Score (0 to 100)

  3. Change in Psychosocial Functioning Measured by BESSI-45

    Time frame: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)

    Psychosocial functioning will be assessed using the Behavioral, Emotional, and Social Skills Inventory (BESSI-45). The BESSI-45 includes 45 items rated on a 5-point Likert scale (1 = "Not at all well" to 5 = "Extremely well"), covering five domains: Self-Management, Social Engagement, Cooperation, Emotional Resilience, and Innovation Skills. Total scores range from 45 to 225, with higher scores reflecting greater psychosocial skills and better psychosocial functioning.

    Unit of Measure: BESSI-45 total score (range 45-225)

  4. Change in Functional Outcomes Measured by PODCI

    Time frame: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)

    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.

  5. Change in Pain Intensity Measured by Visual Analogue Scale (VAS)

    Time frame: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)

    Pain intensity will be assessed using the Visual Analogue Scale for Pain (VAS-Pain), a 10-centimeter horizontal line anchored at the extremes with "0 = no pain" and "10 = worst pain imaginable." Participants mark their current pain level along the line, which is then measured in centimeters from the "no pain" anchor. Scores range from 0 to 10, with higher scores indicating greater pain intensity.

    Unit of Measure: VAS-Pain score (0-10)

  6. Change in Kinesiophobia Measured by Tampa Scale of Kinesiophobia (TSK)

    Time frame: Baseline (T0), up to 1-day after intervention (T1-only for experimental arm), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)

    Fear of movement will be assessed using the Tampa Scale of Kinesiophobia - 13-item version (TSK-13). The TSK-13 includes 13 items rated on a 4-point Likert scale ranging from 1 ("strongly disagree") to 4 ("strongly agree"). Total scores range from 13 to 52, with higher scores indicating greater fear of movement and higher levels of kinesiophobia.

    Unit of Measure: TSK-13 total score (range 13-52)

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study title

Pilot Study "Ready to Sail 2": Evaluation of the Feasibility and Safety of Sail-Assisted Telerehabilitation in Patients With Rare Skeletal Diseases - Assessment of Motor, Psychosocial, and Quality of Life Outcomes

Acronym: PaS2-EXTEND

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 5, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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