Multiple OsteochondromaPaSNCT06397443
Ready to Sail: Evaluating Sailing's Feasibility as Ergotherapy
A study testing 5-day sailing activity in people with Multiple Osteochondroma and Ollier Disease, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
Background Individuals with rare skeletal disorders frequently experience psychological distress, social isolation, unmet needs, and significant challenges due to limited treatment options. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Multiple Osteochondroma, Ollier Disease, Osteogenesis Imperfecta
- What is being tested?
- 5-day sailing activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- 16 May 2024to 13 Sep 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Individuals of any gender
- Diagnosis of a rare skeletal disease, confirmed clinically and/or molecularly
- Age 12 years or older
- No history of surgery within six months prior to study enrollment.
Who cannot join
- Individuals undergoing diagnostic evaluation for a rare skeletal disease
- Participants younger than 12 years of age.
- Individuals who underwent surgery within the preceding 6 months.
- Participants with fractures or musculoskeletal injuries sustained within the past year.
- Individuals who were unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pronti A Salpare: Studio di fattibilità Sull'Impatto Della Vela Come Ergoterapia in Pazienti Con Malattie Rare Scheletriche - Ready to Sail: Evaluating Sailing's Feasibility as Ergotherapy for Rare Skeletal Diseases
Background Individuals with rare skeletal disorders frequently experience psychological distress, social isolation, unmet needs, and significant challenges due to limited treatment options. Adventure Therapy, employing exposure to natural environments, has shown promise in improving self-esteem, autonomy, and social skills in chronic illness and disability populations. This pilot study explores the feasibility and preliminary efficacy of a sailing-based intervention for enhancing physical, social, and psychological well-being in this specific population.
Outcome Measures The primary outcome is to investigates the feasibility of sailing to improve well-being and quality of life in patients living with rare skeletal disorders.
Read more
Furthermore, the investigators hypothesize that participation in a sailing program led by occupational therapists will lead to improvements in:
- Movement confidence: assessing whether sailing enhances participants' ability to move and perform daily activities.
- Mental health: evaluating if sailing reduces anxiety and fear and promotes self-esteem.
- Social interaction: exploring if sailing fosters social connection and reduces feelings of isolation.
Methods The study will use a prospective, single-arm, longitudinal design. Eight participants with rare skeletal disorders will be enrolled in a 5-day sailing-based occupational therapy intervention. Comprehensive pre- and post-intervention assessments will measure psychosocial factors, quality of life, functional mobility, kinesiophobia, and body segment movement using questionnaires and functional scales.
Read the detailed description
Rare skeletal diseases represent a significant global health burden, affecting millions of people worldwide. These chronic, debilitating conditions necessitate the development of optimized clinical pathways and comprehensive support systems.
Adventure therapy (AT) has emerged as a promising intervention for individuals with chronic conditions, demonstrating improvements in self-esteem, autonomy, and social skills. Sailing, a form of AT, offers opportunities for physical activity, social inclusion, and emotional well-being in individuals with disabilities.
This study aims to assess the feasibility of using sailing as an occupational therapy intervention for patients with rare skeletal diseases. We hypothesize that sailing can enhance physical, cognitive, and social functioning in this patient population.
A pilot program of sailing lessons for patients with rare skeletal diseases will be conducted. Participants will undergo assessments of physical, cognitive, and social skills before and after the intervention.
This study will be the first to explore the use of sailing-based AT for this patient population. The findings will inform the development of larger-scale studies and contribute to the optimization of rehabilitation programs for this patient population.
- Being tested
- 5-day sailing activity
- Keywords
- Rare Diseases, QoL, Movement confidence, Mental health, Social interaction, Sailing
- Medical subject headings
- Exostoses, Multiple Hereditary, Enchondromatosis, Osteogenesis Imperfecta, Rare Diseases, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-day sailing activityOther
- Sailing activity (4 h/die)
- Stretching exercises pre and post-sailing activity
- Post-activity debriefing
| Study group | Role | What they receive |
|---|---|---|
| Patients with rare skeletal disorders | Experimental | 5-day sailing activity Receives: Other: 5-day sailing activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related Quality of Life
EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. The questionnaire consists of two sections-descriptive system and visual analog scale (VAS)-and yields two scores: Index Value (IV), and overall health status (VAS).
In the descriptive system section, patients report their level of problems in five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-and rate their health on a 5-level options for adults, and 3-level for adolescents and children. Based on the pattern of their responses, patients generate a health profile ranging from best health (11111 = highest level) to worst health (55555 = lowest level). Each health profile is transformed into an IV, that varies from 0 (absence of life/death) to 1 (perfect health).
The VAS measures the patients' overall health status, with a score ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").
Measured: T0: Baseline
Health-related Quality of Life
EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. The questionnaire consists of two sections-descriptive system and visual analog scale (VAS)-and yields two scores: Index Value (IV), and overall health status (VAS).
In the descriptive system section, patients report their level of problems in five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-and rate their health on a 5-level options for adults, and 3-level for adolescents and children. Based on the pattern of their responses, patients generate a health profile ranging from best health (11111 = highest level) to worst health (55555 = lowest level). Each health profile is transformed into an IV, that varies from 0 (absence of life/death) to 1 (perfect health).
The VAS measures the patients' overall health status, with a score ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").
Measured: T1: up to 2 weeks
Health-related Quality of Life
EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. The questionnaire consists of two sections-descriptive system and visual analog scale (VAS)-and yields two scores: Index Value (IV), and overall health status (VAS).
In the descriptive system section, patients report their level of problems in five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-and rate their health on a 5-level options for adults, and 3-level for adolescents and children. Based on the pattern of their responses, patients generate a health profile ranging from best health (11111 = highest level) to worst health (55555 = lowest level). Each health profile is transformed into an IV, that varies from 0 (absence of life/death) to 1 (perfect health).
The VAS measures the patients' overall health status, with a score ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").
Measured: T2: up to 3 weeks
Health-related Quality of Life
EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. The questionnaire consists of two sections-descriptive system and visual analog scale (VAS)-and yields two scores: Index Value (IV), and overall health status (VAS).
In the descriptive system section, patients report their level of problems in five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-and rate their health on a 5-level options for adults, and 3-level for adolescents and children. Based on the pattern of their responses, patients generate a health profile ranging from best health (11111 = highest level) to worst health (55555 = lowest level). Each health profile is transformed into an IV, that varies from 0 (absence of life/death) to 1 (perfect health).
The VAS measures the patients' overall health status, with a score ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").
Measured: T3: up to 3 months
Secondary outcomes (22)
Self-esteem
Rosenberg Self-Esteem Scale: 10-item scales, ranging from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
Measured: T0: Baseline
Self-esteem
Rosenberg Self-Esteem Scale: 10-item scales, ranging from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
Measured: T1: up to 2 weeks
Self-esteem
Rosenberg Self-Esteem Scale: 10-item scales, ranging from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
Measured: T2: up to 3 weeks
Self-esteem
Rosenberg Self-Esteem Scale is a 10-item scale that assesses the self-esteem, ranging from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
Measured: T3: up to 3 months
Motor Coordination
Performance Oriented Mobility Assesment (Tinetti Balance Scale) is an administered 16-item task-oriented test that measures gait and balance abilities, primarily to assess fall risk. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16. The total score (Fall Risk) ranges from 0 to 28, with higher scores indicating better balance and gait performance (19 or below=High risk of falls; 20-23=Moderate risk of falls; 24-28=Low risk of falls).
Measured: T0: Baseline
Motor Coordination
Performance Oriented Mobility Assesment (Tinetti Balance Scale) is an administered 16-item task-oriented test that measures gait and balance abilities, primarily to assess fall risk. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16. The total score (Fall Risk) ranges from 0 to 28, with higher scores indicating better balance and gait performance (19 or below=High risk of falls; 20-23=Moderate risk of falls; 24-28=Low risk of falls).
Measured: T1: up to 2 weeks
Motor Coordination
Performance Oriented Mobility Assesment (Tinetti Balance Scale) is an administered 16-item task-oriented test that measures gait and balance abilities, primarily to assess fall risk. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16. The total score (Fall Risk) ranges from 0 to 28, with higher scores indicating better balance and gait performance (19 or below=High risk of falls; 20-23=Moderate risk of falls; 24-28=Low risk of falls).
Measured: T2: up to 3 weeks
Motor Coordination
Performance Oriented Mobility Assesment (Tinetti Balance Scale) is an administered 16-item task-oriented test that measures gait and balance abilities, primarily to assess fall risk. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16. The total score (Fall Risk) ranges from 0 to 28, with higher scores indicating better balance and gait performance (19 or below=High risk of falls; 20-23=Moderate risk of falls; 24-28=Low risk of falls).
Measured: T3: up to 3 months
Balance
Berg Balance Scale is a 14-item objective measure that assesses static balance and fall risk, item-level scores range from 0-4, determined by ability to perform the assessed activity. The total score ranges from 0 to 56, with higher scores indicating better balance. A score of less than 45 suggests an increased risk of falling.
Measured: T0: Baseline
Balance
Berg Balance Scale is a 14-item objective measure that assesses static balance and fall risk, item-level scores range from 0-4, determined by ability to perform the assessed activity. The total score ranges from 0 to 56, with higher scores indicating better balance. A score of less than 45 suggests an increased risk of falling.
Measured: T1: up to 2 weeks
Balance
Berg Balance Scale is a 14-item objective measure that assesses static balance and fall risk, item-level scores range from 0-4, determined by ability to perform the assessed activity. The total score ranges from 0 to 56, with higher scores indicating better balance. A score of less than 45 suggests an increased risk of falling.
Measured: T2: up to 3 weeks
Balance
Berg Balance Scale is a 14-item objective measure that assesses static balance and fall risk, item-level scores range from 0-4, determined by ability to perform the assessed activity. The total score ranges from 0 to 56, with higher scores indicating better balance. A score of less than 45 suggests an increased risk of falling.
Measured: T3: up to 3 months
Kinesiophobia
The Tampa Scale for Kinesiophobia (TSK) is a validated self-report questionnaire designed to assess the fear of movement or (re)injury in individuals experiencing pain or musculoskeletal disorders. The TSK consists of 13 items (Italian validated version), each rated on a 4-point Likert scale, ranging from 1 ("Strongly Disagree") to 4 ("Strongly Agree"). The scores are summed to yield a total score ranging from 13 to 52, with higher scores indicating greater levels of kinesiophobia.
The TSK includes two subscales: 1.Activity Avoidance, with a score ranging from 6 to 24; 2.Harm Beliefs, with a score ranging from 7 to 28.
Higher scores on both the Activity Avoidance and Harm Beliefs subscales indicate greater levels of kinesiophobia, reflecting increased fear of movement due to injury concerns (Activity Avoidance subscale) or harmful beliefs about physical activity (Harm Beliefs subscale).
Measured: T0: Baseline
Kinesiophobia
The Tampa Scale for Kinesiophobia (TSK) is a validated self-report questionnaire designed to assess the fear of movement or (re)injury in individuals experiencing pain or musculoskeletal disorders. The TSK consists of 13 items (Italian validated version), each rated on a 4-point Likert scale, ranging from 1 ("Strongly Disagree") to 4 ("Strongly Agree"). The scores are summed to yield a total score ranging from 13 to 52, with higher scores indicating greater levels of kinesiophobia.
The TSK includes two subscales: 1.Activity Avoidance, with a score ranging from 6 to 24; 2.Harm Beliefs, with a score ranging from 7 to 28.
Higher scores on both the Activity Avoidance and Harm Beliefs subscales indicate greater levels of kinesiophobia, reflecting increased fear of movement due to injury concerns (Activity Avoidance subscale) or harmful beliefs about physical activity (Harm Beliefs subscale).
Measured: T2: up to 3 weeks
Kinesiophobia
The Tampa Scale for Kinesiophobia (TSK) is a validated self-report questionnaire designed to assess the fear of movement or (re)injury in individuals experiencing pain or musculoskeletal disorders. The TSK consists of 13 items (Italian validated version), each rated on a 4-point Likert scale, ranging from 1 ("Strongly Disagree") to 4 ("Strongly Agree"). The scores are summed to yield a total score ranging from 13 to 52, with higher scores indicating greater levels of kinesiophobia.
The TSK includes two subscales: 1.Activity Avoidance, with a score ranging from 6 to 24; 2.Harm Beliefs, with a score ranging from 7 to 28.
Higher scores on both the Activity Avoidance and Harm Beliefs subscales indicate greater levels of kinesiophobia, reflecting increased fear of movement due to injury concerns (Activity Avoidance subscale) or harmful beliefs about physical activity (Harm Beliefs subscale).
Measured: T3: up to 3 months
Well-being and Mental Health
Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report questionnaire designed to assess psychological distress and monitor treatment response. It consists of 34 items evaluating emotional state and perceived well-being over the past week, rated on a 5-point Likert scale from 0 ("Not at all") to 4 ("Most or all of the time").
The total score is calculated as the mean of all item scores and can be reported in two ways: 1.Raw score: The mean of all item scores (range: 0-4). 2.Standardized score: Obtained by multiplying the raw score by 10, yielding a scale from 0 to 40.
The data presented in the results refer to the raw score.
Score Interpretation:
0.00-0.99: No clinical distress or minimal risk. 1.00-1.99: Mild distress, potentially significant. 2.00-2.99: Moderate distress, generally indicative of the need for intervention.
3.00-4.00: Severe distress, highly indicative of the need for immediate clinical intervention.
Measured: T0: Baseline
Well-being and Mental Health
Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report questionnaire designed to assess psychological distress and monitor treatment response. It consists of 34 items evaluating emotional state and perceived well-being over the past week, rated on a 5-point Likert scale from 0 ("Not at all") to 4 ("Most or all of the time").
The total score is calculated as the mean of all item scores and can be reported in two ways: 1.Raw score: The mean of all item scores (range: 0-4). 2.Standardized score: Obtained by multiplying the raw score by 10, yielding a scale from 0 to 40.
The data presented in the results refer to the raw score.
Score Interpretation:
0.00-0.99: No clinical distress or minimal risk. 1.00-1.99: Mild distress, potentially significant. 2.00-2.99: Moderate distress, generally indicative of the need for intervention.
3.00-4.00: Severe distress, highly indicative of the need for immediate clinical intervention.
Measured: T2: up to 3 weeks
Well-being and Mental Health
Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report questionnaire designed to assess psychological distress and monitor treatment response. It consists of 34 items evaluating emotional state and perceived well-being over the past week, rated on a 5-point Likert scale from 0 ("Not at all") to 4 ("Most or all of the time").
The total score is calculated as the mean of all item scores and can be reported in two ways: 1.Raw score: The mean of all item scores (range: 0-4). 2.Standardized score: Obtained by multiplying the raw score by 10, yielding a scale from 0 to 40.
The data presented in the results refer to the raw score.
Score Interpretation:
0.00-0.99: No clinical distress or minimal risk. 1.00-1.99: Mild distress, potentially significant. 2.00-2.99: Moderate distress, generally indicative of the need for intervention.
3.00-4.00: Severe distress, highly indicative of the need for immediate clinical intervention.
Measured: T3: up to 3 months
Physical Functioning and Psychological Well-being
Pediatric Outcomes Data Collection (PODCI) evaluates functional health status through an 83-item questionnaire, and uses domain-specific scales. Each scale generates a score ranging from 0 to 100, with higher scores indicating better functioning or less impairment.
Measured: T0: Baseline
Physical Functioning and Psychological Well-being
Pediatric Outcomes Data Collection (PODCI) evaluates functional health status through an 83-item questionnaire, and uses domain-specific scales. Each scale generates a score ranging from 0 to 100, with higher scores indicating better functioning or less impairment.
Measured: T1: up to 2 weeks
Physical Functioning and Psychological Well-being
Pediatric Outcomes Data Collection (PODCI) evaluates functional health status through an 83-item questionnaire, and uses domain-specific scales. Each scale generates a score ranging from 0 to 100, with higher scores indicating better functioning or less impairment.
Measured: T2: up to 3 weeks
Physical Functioning and Psychological Well-being
Pediatric Outcomes Data Collection (PODCI) evaluates functional health status through an 83-item questionnaire, and uses domain-specific scales. Each scale generates a score ranging from 0 to 100, with higher scores indicating better functioning or less impairment.
Measured: T3: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2024
- Study start16 May 2024
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Multiple OsteochondromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Sangiorgi, Istituto Ortopedico Rizzoli
- Investigators
- Luca Sangiorgi, MD, PhD, Principal investigator, IRCCS Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06397443
- Sponsor's protocol ID
- 115/2024/Sper/IOR
- Acronym
- PaS
- Status last verified
- Mar 2025
- First submitted
- 11 Apr 2024
- Last updated
- 21 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cornaglia Ferraris P. [Adventure therapy: principles, practice, perspectives.]. Recenti Prog Med. 2018 Oct;109(10):487-493. doi: 10.1701/3010.30086. Italian.
PubMed 30394410MacLachlan M. Sailing as an Intervention. In: MacLachlan M, editor. Maritime Psychology: Research in Organizational & Health Behavior at Sea. Cham: Springer International Publishing; 2017. https://doi.org/10.1007/978-3-319-45430-6_10
Thompson T, Lamont-Robinson C, Williams V. At sea with disability! Transformative learning in medical undergraduates voyaging with disabled sailors. Med Educ. 2016 Aug;50(8):866-79. doi: 10.1111/medu.13087.
PubMed 27402046Recio AC, Becker D, Morgan M, Saunders NR, Schramm LP, McDonald JW 3rd. Use of a virtual reality physical ride-on sailing simulator as a rehabilitation tool for recreational sports and community reintegration: a pilot study. Am J Phys Med Rehabil. 2013 Dec;92(12):1104-9. doi: 10.1097/PHM.0000000000000012.
PubMed 24252935Tracey D, Gray T, Truong S, Ward K. Combining Acceptance and Commitment Therapy With Adventure Therapy to Promote Psychological Wellbeing for Children At-Risk. Front Psychol. 2018 Aug 27;9:1565. doi: 10.3389/fpsyg.2018.01565. eCollection 2018.
PubMed 30210398Capurso, M.; Borsci, S. Effects of a Tall Ship Sail Training Experience on Adolescents' Self-Concept. International Journal of Educational Research 2013, 58, 15-24. https://doi.org/10.1016/j.ijer.2013.01.004.
Gill E, Goldenberg M, Starnes H, Phelan S. Outdoor adventure therapy to increase physical activity in young adult cancer survivors. J Psychosoc Oncol. 2016 May-Jun;34(3):184-99. doi: 10.1080/07347332.2016.1157718. Epub 2016 Mar 3.
PubMed 26939742Zebrack B, Kwak M, Sundstrom L. First Descents, an adventure program for young adults with cancer: who benefits? Support Care Cancer. 2017 Dec;25(12):3665-3673. doi: 10.1007/s00520-017-3792-7. Epub 2017 Jun 27.
PubMed 28656467Aprile I, Iacovelli C, Iuvone L, Imbimbo I, Cruciani A, Pecchioli C, Manozzi FM, Padua L. Use of a Virtual-Technological Sailing Program to Prepare Children With Disabilities for a Real Sailing Course: Effects on Balance and Quality of Life. J Child Neurol. 2016 Jul;31(8):1074-80. doi: 10.1177/0883073816638756. Epub 2016 Mar 28.
PubMed 27021144Boarini M, Banchelli F, Fittipaldi S, Scognamiglio D, Farella GM, Platano D, Rogati G, Di Sipio E, Villa G, Berti L, Leardini A, Sartini S, Scopinaro A, Sangiorgi L. Feasibility and safety of sailing based rehabilitation for rare skeletal disorders using wearable sensors and patient reported outcomes. Sci Rep. 2025 Oct 23;15(1):37153. doi: 10.1038/s41598-025-22231-8.
PubMed 41131085
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pronti A Salpare: Studio di fattibilità Sull'Impatto Della Vela Come Ergoterapia in Pazienti Con Malattie Rare Scheletriche - Ready to Sail: Evaluating Sailing's Feasibility as Ergotherapy for Rare Skeletal Diseases
- ClinicalTrials.gov ID
- NCT06397443
- Acronym / sponsor ID
- PaS / 115/2024/Sper/IOR
- Keywords
- Rare Diseases, QoL, Movement confidence, Mental health, Social interaction, Sailing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 16 May 2024 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 2 May 2024 (actual)
- Results
- Posted 21 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background Individuals with rare skeletal disorders frequently experience psychological distress, social isolation, unmet needs, and significant challenges due to limited treatment options. Adventure Therapy, employing exposure to natural environments, has shown promise in improving self-esteem, autonomy, and social skills in chronic illness and disability populations. This pilot study explores the feasibility and preliminary efficacy of a sailing-based intervention for enhancing physical, social, and psychological well-being in this specific population.
Outcome Measures The primary outcome is to investigates the feasibility of sailing to improve well-being and quality of life in patients living with rare skeletal disorders.
Furthermore, the investigators hypothesize that participation in a sailing program led by occupational therapists will lead to improvements in:
- Movement confidence: assessing whether sailing enhances participants' ability to move and perform daily activities.
- Mental health: evaluating if sailing reduces anxiety and fear and promotes self-esteem.
- Social interaction: exploring if sailing fosters social connection and reduces feelings of isolation.
Methods The study will use a prospective, single-arm, longitudinal design. Eight participants with rare skeletal disorders will be enrolled in a 5-day sailing-based occupational therapy intervention. Comprehensive pre- and post-intervention assessments will measure psychosocial factors, quality of life, functional mobility, kinesiophobia, and body segment movement using questionnaires and functional scales.
Detailed description
Rare skeletal diseases represent a significant global health burden, affecting millions of people worldwide. These chronic, debilitating conditions necessitate the development of optimized clinical pathways and comprehensive support systems.
Adventure therapy (AT) has emerged as a promising intervention for individuals with chronic conditions, demonstrating improvements in self-esteem, autonomy, and social skills. Sailing, a form of AT, offers opportunities for physical activity, social inclusion, and emotional well-being in individuals with disabilities.
This study aims to assess the feasibility of using sailing as an occupational therapy intervention for patients with rare skeletal diseases. We hypothesize that sailing can enhance physical, cognitive, and social functioning in this patient population.
A pilot program of sailing lessons for patients with rare skeletal diseases will be conducted. Participants will undergo assessments of physical, cognitive, and social skills before and after the intervention.
This study will be the first to explore the use of sailing-based AT for this patient population. The findings will inform the development of larger-scale studies and contribute to the optimization of rehabilitation programs for this patient population.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with rare skeletal disorders | Experimental | Other: 5-day sailing activity5-day sailing activity |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals of any gender
- Diagnosis of a rare skeletal disease, confirmed clinically and/or molecularly
- Age 12 years or older
- No history of surgery within six months prior to study enrollment.
Key exclusion criteria (5 listed)
- Individuals undergoing diagnostic evaluation for a rare skeletal disease
- Participants younger than 12 years of age.
- Individuals who underwent surgery within the preceding 6 months.
- Participants with fractures or musculoskeletal injuries sustained within the past year.
- Individuals who were unable to provide written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5-day sailing activity* Sailing activity (4 h/die) * Stretching exercises pre and post-sailing activity * Post-activity debriefing | Other | Patients with rare skeletal disorders |
Primary outcome
Health-related Quality of Life
Time frame: T0: Baseline
EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. The questionnaire consists of two sections-descriptive system and visual analog scale (VAS)-and yields two scores: Index Value (IV), and overall health status (VAS). In the descriptive system section, patients report their level of problems in five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-and rate their health on a 5-level options for adults, and 3-level for adolescents and children. Based on the pattern of their responses, patients generate a health profile ranging from best health (11111 = highest level) to worst health (55555 = lowest level). Each health profile is transformed into an IV, that varies from 0 (absence of life/death) to 1 (perfect health). The VAS measures the patients' overall health status, with a score ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").
Health-related Quality of Life
Time frame: T1: up to 2 weeks
EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. The questionnaire consists of two sections-descriptive system and visual analog scale (VAS)-and yields two scores: Index Value (IV), and overall health status (VAS). In the descriptive system section, patients report their level of problems in five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-and rate their health on a 5-level options for adults, and 3-level for adolescents and children. Based on the pattern of their responses, patients generate a health profile ranging from best health (11111 = highest level) to worst health (55555 = lowest level). Each health profile is transformed into an IV, that varies from 0 (absence of life/death) to 1 (perfect health). The VAS measures the patients' overall health status, with a score ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").
Health-related Quality of Life
Time frame: T2: up to 3 weeks
EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. The questionnaire consists of two sections-descriptive system and visual analog scale (VAS)-and yields two scores: Index Value (IV), and overall health status (VAS). In the descriptive system section, patients report their level of problems in five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-and rate their health on a 5-level options for adults, and 3-level for adolescents and children. Based on the pattern of their responses, patients generate a health profile ranging from best health (11111 = highest level) to worst health (55555 = lowest level). Each health profile is transformed into an IV, that varies from 0 (absence of life/death) to 1 (perfect health). The VAS measures the patients' overall health status, with a score ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").
Health-related Quality of Life
Time frame: T3: up to 3 months
EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. The questionnaire consists of two sections-descriptive system and visual analog scale (VAS)-and yields two scores: Index Value (IV), and overall health status (VAS). In the descriptive system section, patients report their level of problems in five dimensions-mobility, self-care, usual activities, pain/discomfort, and anxiety/depression-and rate their health on a 5-level options for adults, and 3-level for adolescents and children. Based on the pattern of their responses, patients generate a health profile ranging from best health (11111 = highest level) to worst health (55555 = lowest level). Each health profile is transformed into an IV, that varies from 0 (absence of life/death) to 1 (perfect health). The VAS measures the patients' overall health status, with a score ranging from 0 ("The worst health you can imagine") to 100 ("The best health you can imagine").
22 secondary outcomes
Self-esteem
Time frame: T0: Baseline
Self-esteem
Time frame: T1: up to 2 weeks
Self-esteem
Time frame: T2: up to 3 weeks
Self-esteem
Time frame: T3: up to 3 months
Motor Coordination
Time frame: T0: Baseline
Motor Coordination
Time frame: T1: up to 2 weeks
Motor Coordination
Time frame: T2: up to 3 weeks
Motor Coordination
Time frame: T3: up to 3 months
Balance
Time frame: T0: Baseline
Balance
Time frame: T1: up to 2 weeks
Balance
Time frame: T2: up to 3 weeks
Balance
Time frame: T3: up to 3 months
Kinesiophobia
Time frame: T0: Baseline
Kinesiophobia
Time frame: T2: up to 3 weeks
Kinesiophobia
Time frame: T3: up to 3 months
Well-being and Mental Health
Time frame: T0: Baseline
Well-being and Mental Health
Time frame: T2: up to 3 weeks
Well-being and Mental Health
Time frame: T3: up to 3 months
Physical Functioning and Psychological Well-being
Time frame: T0: Baseline
Physical Functioning and Psychological Well-being
Time frame: T1: up to 2 weeks
Physical Functioning and Psychological Well-being
Time frame: T2: up to 3 weeks
Physical Functioning and Psychological Well-being
Time frame: T3: up to 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30394410Cornaglia Ferraris P. [Adventure therapy: principles, practice, perspectives.]. Recenti Prog Med. 2018 Oct;109(10):487-493. doi: 10.1701/3010.30086. Italian.
- BackgroundMacLachlan M. Sailing as an Intervention. In: MacLachlan M, editor. Maritime Psychology: Research in Organizational & Health Behavior at Sea. Cham: Springer International Publishing; 2017. https://doi.org/10.1007/978-3-319-45430-6_10
- Background: PubMed 27402046Thompson T, Lamont-Robinson C, Williams V. At sea with disability! Transformative learning in medical undergraduates voyaging with disabled sailors. Med Educ. 2016 Aug;50(8):866-79. doi: 10.1111/medu.13087.
- Background: PubMed 24252935Recio AC, Becker D, Morgan M, Saunders NR, Schramm LP, McDonald JW 3rd. Use of a virtual reality physical ride-on sailing simulator as a rehabilitation tool for recreational sports and community reintegration: a pilot study. Am J Phys Med Rehabil. 2013 Dec;92(12):1104-9. doi: 10.1097/PHM.0000000000000012.
- Background: PubMed 30210398Tracey D, Gray T, Truong S, Ward K. Combining Acceptance and Commitment Therapy With Adventure Therapy to Promote Psychological Wellbeing for Children At-Risk. Front Psychol. 2018 Aug 27;9:1565. doi: 10.3389/fpsyg.2018.01565. eCollection 2018.
- BackgroundCapurso, M.; Borsci, S. Effects of a Tall Ship Sail Training Experience on Adolescents' Self-Concept. International Journal of Educational Research 2013, 58, 15-24. https://doi.org/10.1016/j.ijer.2013.01.004.
- Background: PubMed 26939742Gill E, Goldenberg M, Starnes H, Phelan S. Outdoor adventure therapy to increase physical activity in young adult cancer survivors. J Psychosoc Oncol. 2016 May-Jun;34(3):184-99. doi: 10.1080/07347332.2016.1157718. Epub 2016 Mar 3.
- Background: PubMed 28656467Zebrack B, Kwak M, Sundstrom L. First Descents, an adventure program for young adults with cancer: who benefits? Support Care Cancer. 2017 Dec;25(12):3665-3673. doi: 10.1007/s00520-017-3792-7. Epub 2017 Jun 27.
- Background: PubMed 27021144Aprile I, Iacovelli C, Iuvone L, Imbimbo I, Cruciani A, Pecchioli C, Manozzi FM, Padua L. Use of a Virtual-Technological Sailing Program to Prepare Children With Disabilities for a Real Sailing Course: Effects on Balance and Quality of Life. J Child Neurol. 2016 Jul;31(8):1074-80. doi: 10.1177/0883073816638756. Epub 2016 Mar 28.
- Derived from this study: PubMed 41131085Boarini M, Banchelli F, Fittipaldi S, Scognamiglio D, Farella GM, Platano D, Rogati G, Di Sipio E, Villa G, Berti L, Leardini A, Sartini S, Scopinaro A, Sangiorgi L. Feasibility and safety of sailing based rehabilitation for rare skeletal disorders using wearable sensors and patient reported outcomes. Sci Rep. 2025 Oct 23;15(1):37153. doi: 10.1038/s41598-025-22231-8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luca Sangiorgi, MD, PhD principal investigator
IRCCS Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5-day sailing activity in people with Multiple Osteochondroma and Ollier Disease, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related Quality of Life (time frame: T0: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06397443, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2025.