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

NCT07102875 | Completed

• 1 other identifier: 363/2025/Sper/IOR
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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

Keywords

Rare Diseases; Musculoskeletal Diseases; Telerehabilitation; Physical Therapy Modalities; Games, Recreational; Quality of Life; Feasibility Study; Social Behavior; Psychological Well-Being; Adolescent; Young Adult; Wearable Devices; Biomechanical Movement Capture

Outcome Measures

Primary Outcomes (3)

• 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

  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 (%)

  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

  At 6 months after baseline (end of intervention period)

Secondary Outcomes (6)

• Change in Motor Function Measured by Inertial Measurement Units

  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)

• 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), at 3-Month Follow-Up (T2), and at 6-Month Follow-Up (T3)

• Change in Psychosocial Functioning Measured by BESSI-45

  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)

• Change in Functional Outcomes Measured by PODCI

  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)

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

  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)

Study Arms (2)

Sailing Intervention Followed by Home-Based Telerehabilitation Program

EXPERIMENTAL

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.

Behavioral: Sailing Intervention Plus Home-Based Telerehabilitation

Home-Based Telerehabilitation Program

ACTIVE COMPARATOR

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.

Behavioral: Home-Based Telerehabilitation

Interventions

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.

Also known as: 5-day sailing activity

Sailing Intervention Followed by Home-Based Telerehabilitation Program

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.

Home-Based Telerehabilitation Program

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

IRCCS Istituto Ortopedico Rizzoli

Bologna, Italy, 40136, Italy

Location

Related Publications (4)

• Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.

  PMID: 23295957 BACKGROUND

• Boarini M, Romeo A, Banchelli F, Grippa E, Forni S, la Forgia MC, Scognamiglio D, Ferraris PC, Sangiorgi L. Nature-based interventions for individuals with rare skeletal disorders: evaluation of a 5-day sailing program on health-related quality of life. Sci Rep. 2024 Nov 1;14(1):26339. doi: 10.1038/s41598-024-77934-1.

  PMID: 39487306 BACKGROUND

• Cappelletti S, Tondo I, Pietrafusa N, Renzetti T, Pannacci I, Gentile S, Perrucci M, Calabrese C, Ferraris PC, Specchio N, Vigevano F. Improvement of quality of life in adolescents with epilepsy after an empowerment and sailing experience. Epilepsy Behav. 2020 May;106:106957. doi: 10.1016/j.yebeh.2020.106957. Epub 2020 Mar 16.

  PMID: 32193096 BACKGROUND

• Murray CJ, Vos T, Lozano R, Naghavi M, Flaxman AD, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, Bernabe E, Bhalla K, Bhandari B, Bikbov B, Bin Abdulhak A, Birbeck G, Black JA, Blencowe H, Blore JD, Blyth F, Bolliger I, Bonaventure A, Boufous S, Bourne R, Boussinesq M, Braithwaite T, Brayne C, Bridgett L, Brooker S, Brooks P, Brugha TS, Bryan-Hancock C, Bucello C, Buchbinder R, Buckle G, Budke CM, Burch M, Burney P, Burstein R, Calabria B, Campbell B, Canter CE, Carabin H, Carapetis J, Carmona L, Cella C, Charlson F, Chen H, Cheng AT, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahiya M, Dahodwala N, Damsere-Derry J, Danaei G, Davis A, De Leo D, Degenhardt L, Dellavalle R, Delossantos A, Denenberg J, Derrett S, Des Jarlais DC, Dharmaratne SD, Dherani M, Diaz-Torne C, Dolk H, Dorsey ER, Driscoll T, Duber H, Ebel B, Edmond K, Elbaz A, Ali SE, Erskine H, Erwin PJ, Espindola P, Ewoigbokhan SE, Farzadfar F, Feigin V, Felson DT, Ferrari A, Ferri CP, Fevre EM, Finucane MM, Flaxman S, Flood L, Foreman K, Forouzanfar MH, Fowkes FG, Fransen M, Freeman MK, Gabbe BJ, Gabriel SE, Gakidou E, Ganatra HA, Garcia B, Gaspari F, Gillum RF, Gmel G, Gonzalez-Medina D, Gosselin R, Grainger R, Grant B, Groeger J, Guillemin F, Gunnell D, Gupta R, Haagsma J, Hagan H, Halasa YA, Hall W, Haring D, Haro JM, Harrison JE, Havmoeller R, Hay RJ, Higashi H, Hill C, Hoen B, Hoffman H, Hotez PJ, Hoy D, Huang JJ, Ibeanusi SE, Jacobsen KH, James SL, Jarvis D, Jasrasaria R, Jayaraman S, Johns N, Jonas JB, Karthikeyan G, Kassebaum N, Kawakami N, Keren A, Khoo JP, King CH, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Laden F, Lalloo R, Laslett LL, Lathlean T, Leasher JL, Lee YY, Leigh J, Levinson D, Lim SS, Limb E, Lin JK, Lipnick M, Lipshultz SE, Liu W, Loane M, Ohno SL, Lyons R, Mabweijano J, MacIntyre MF, Malekzadeh R, Mallinger L, Manivannan S, Marcenes W, March L, Margolis DJ, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGill N, McGrath J, Medina-Mora ME, Meltzer M, Mensah GA, Merriman TR, Meyer AC, Miglioli V, Miller M, Miller TR, Mitchell PB, Mock C, Mocumbi AO, Moffitt TE, Mokdad AA, Monasta L, Montico M, Moradi-Lakeh M, Moran A, Morawska L, Mori R, Murdoch ME, Mwaniki MK, Naidoo K, Nair MN, Naldi L, Narayan KM, Nelson PK, Nelson RG, Nevitt MC, Newton CR, Nolte S, Norman P, Norman R, O'Donnell M, O'Hanlon S, Olives C, Omer SB, Ortblad K, Osborne R, Ozgediz D, Page A, Pahari B, Pandian JD, Rivero AP, Patten SB, Pearce N, Padilla RP, Perez-Ruiz F, Perico N, Pesudovs K, Phillips D, Phillips MR, Pierce K, Pion S, Polanczyk GV, Polinder S, Pope CA 3rd, Popova S, Porrini E, Pourmalek F, Prince M, Pullan RL, Ramaiah KD, Ranganathan D, Razavi H, Regan M, Rehm JT, Rein DB, Remuzzi G, Richardson K, Rivara FP, Roberts T, Robinson C, De Leon FR, Ronfani L, Room R, Rosenfeld LC, Rushton L, Sacco RL, Saha S, Sampson U, Sanchez-Riera L, Sanman E, Schwebel DC, Scott JG, Segui-Gomez M, Shahraz S, Shepard DS, Shin H, Shivakoti R, Singh D, Singh GM, Singh JA, Singleton J, Sleet DA, Sliwa K, Smith E, Smith JL, Stapelberg NJ, Steer A, Steiner T, Stolk WA, Stovner LJ, Sudfeld C, Syed S, Tamburlini G, Tavakkoli M, Taylor HR, Taylor JA, Taylor WJ, Thomas B, Thomson WM, Thurston GD, Tleyjeh IM, Tonelli M, Towbin JA, Truelsen T, Tsilimbaris MK, Ubeda C, Undurraga EA, van der Werf MJ, van Os J, Vavilala MS, Venketasubramanian N, Wang M, Wang W, Watt K, Weatherall DJ, Weinstock MA, Weintraub R, Weisskopf MG, Weissman MM, White RA, Whiteford H, Wiebe N, Wiersma ST, Wilkinson JD, Williams HC, Williams SR, Witt E, Wolfe F, Woolf AD, Wulf S, Yeh PH, Zaidi AK, Zheng ZJ, Zonies D, Lopez AD, AlMazroa MA, Memish ZA. Disability-adjusted life years (DALYs) for 291 diseases and injuries in 21 regions, 1990-2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2197-223. doi: 10.1016/S0140-6736(12)61689-4.

  PMID: 23245608 BACKGROUND

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MeSH Terms

Conditions

Rare Diseases; Musculoskeletal Diseases; Social Behavior; Psychological Well-Being

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Personal Satisfaction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Rare Skeletal Disorders Department

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: August 5, 2025
• Study Start: July 15, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data sharing commences for 6 months post-publication; data remains available for a minimum of 5 years (extendable to 10 years).
• Access Criteria: Researchers may request data by contacting the corresponding author and submitting: (1) a research proposal (maximum 2 pages), (2) a signed Data Use Agreement, and (3) ethics approval documentation if the secondary analysis constitutes human subjects' research. Requests are reviewed within 30 calendar days; approved requests receive data within 60 days via secure file transfer.

Locations

IT (1)