Ready to Sail: Evaluating Sailing's Feasibility as Ergotherapy

Osteogenesis Imperfecta Clinical Trial

— PaS  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06397443
• Other study ID #: 115/2024/Sper/IOR
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 24, 2024
• Est. completion date: September 13, 2024

Study information

• Verified date: May 2024
• Source: Istituto Ortopedico Rizzoli
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 8
• Est. completion date: September 13, 2024
• Est. primary completion date: September 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Exostoses, Multiple Hereditary
• Multiple Osteochondroma
• Ollier Disease
• Osteogenesis Imperfecta

Intervention

Other:
• 5-day sailing activity
Sailing activity (4 h/die) Stretching exercises pre and post-sailing activity Post-activity debriefing

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Rizzoli	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Rizzoli

Country where clinical trial is conducted

Italy, 

References & Publications (9)

Aprile 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. — View Citation

Capurso, 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.

Cornaglia Ferraris P. [Adventure therapy: principles, practice, perspectives.]. Recenti Prog Med. 2018 Oct;109(10):487-493. doi: 10.1701/3010.30086. Italian. — View Citation

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. — View Citation

MacLachlan 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

Recio 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. — View Citation

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. — View Citation

Tracey 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. — View Citation

Zebrack 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related Quality of Life	EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. EQ-5D assesses health status in terms of five dimensions of health, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and with EQ-5D visual analogue scale. It is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition.	T0: Baseline
Primary	Health-related Quality of Life	EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. EQ-5D assesses health status in terms of five dimensions of health, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and with EQ-5D visual analogue scale. It is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition.	T1: up to 2 weeks
Primary	Health-related Quality of Life	EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. EQ-5D assesses health status in terms of five dimensions of health, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and with EQ-5D visual analogue scale. It is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition.	T2: up to 3 weeks
Primary	Health-related Quality of Life	EuroQol 5-Dimension (EQ-5D) instrument offers valuable information about patient-reported health status. EQ-5D assesses health status in terms of five dimensions of health, mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, and with EQ-5D visual analogue scale. It is considered a 'generic' questionnaire because these dimensions are not specific to any one patient group or health condition.	T3: up to 3 months
Primary	Information on the functioning and disability of an individual	The World Health Organisation Disability Assessment Schedule (WHODAS 2.0) is a standardized method for measuring health and disability by assessing the same individual before and after the intervention. WHODAS 2.0 is a 36-item questionnaire and captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society.	T0: Baseline
Primary	Information on the functioning and disability of an individual	The World Health Organisation Disability Assessment Schedule (WHODAS 2.0) is a standardized method for measuring health and disability by assessing the same individual before and after the intervention. WHODAS 2.0 is a 36-item questionnaire and captures the level of functioning in six domains of life: Cognition - understanding and communicating, Mobility - moving and getting around, Self-care - attending to one's hygiene, dressing, eating and staying alone, Getting along - interacting with other people, Life activities - domestic responsibilities, leisure, work and school, Participation - joining in community activities, participating in society.	T3: up to 3 months
Secondary	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.	T0: Baseline
Secondary	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.	T1: up to 2 weeks
Secondary	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.	T2: up to 3 weeks
Secondary	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.	T3: up to 3 months
Secondary	Motor coordination	Performance Oriented Mobility Assesment (Tinetti Balance Scale) is an administered 16-item task-oriented test that measures gait and balance abilities, it uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28.	T0: Baseline
Secondary	Motor coordination	Performance Oriented Mobility Assesment (Tinetti Balance Scale) is an administered 16-item task-oriented test that measures gait and balance abilities, it uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28.	T1: up to 2 weeks
Secondary	Motor coordination	Performance Oriented Mobility Assesment (Tinetti Balance Scale) is an administered 16-item task-oriented test that measures gait and balance abilities, it uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28.	T2: up to 3 weeks
Secondary	Motor coordination	Performance Oriented Mobility Assesment (Tinetti Balance Scale) is an administered 16-item task-oriented test that measures gait and balance abilities, it uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16 totalling 28.	T3: up to 3 months
Secondary	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 item scores are then summed with a maximum of 56.	T0: Baseline
Secondary	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 item scores are then summed with a maximum of 56.	T1: up to 2 weeks
Secondary	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 item scores are then summed with a maximum of 56.	T2: up to 3 weeks
Secondary	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 item scores are then summed with a maximum of 56.	T3: up to 3 months
Secondary	Kinesiophobia	Tampa Scale is a self-reported questionnaire that quantifies fear of movement, or (re)injury, it uses a 4-point Likert scale (Strongly Disagree-Disagree-Agree-Strongly Agree) with statements that have been later linked to the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury.	T0: Baseline
Secondary	Kinesiophobia	Tampa Scale is a self-reported questionnaire that quantifies fear of movement, or (re)injury, it uses a 4-point Likert scale (Strongly Disagree-Disagree-Agree-Strongly Agree) with statements that have been later linked to the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury.	T1: up to 2 weeks
Secondary	Kinesiophobia	Tampa Scale is a self-reported questionnaire that quantifies fear of movement, or (re)injury, it uses a 4-point Likert scale (Strongly Disagree-Disagree-Agree-Strongly Agree) with statements that have been later linked to the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury.	T2: up to 3 weeks
Secondary	Kinesiophobia	Tampa Scale is a self-reported questionnaire that quantifies fear of movement, or (re)injury, it uses a 4-point Likert scale (Strongly Disagree-Disagree-Agree-Strongly Agree) with statements that have been later linked to the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury.	T3: up to 3 months
Secondary	Well-being and Mental Health	Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of psychological distress designed to be administered during a course of treatment to determine treatment response. It compries 34 questions about how the participants have been feeling over the last week, using a 5-point scale. The scale covers four dimensions: Subjective well-being, Problems/symptoms, Life functioning, and Risk/harm.	T0: Baseline
Secondary	Well-being and Mental Health	Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of psychological distress designed to be administered during a course of treatment to determine treatment response. It compries 34 questions about how the participants have been feeling over the last week, using a 5-point scale. The scale covers four dimensions: Subjective well-being, Problems/symptoms, Life functioning, and Risk/harm.	T1: up to 2 weeks
Secondary	Well-being and Mental Health	Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of psychological distress designed to be administered during a course of treatment to determine treatment response. It compries 34 questions about how the participants have been feeling over the last week, using a 5-point scale. The scale covers four dimensions: Subjective well-being, Problems/symptoms, Life functioning, and Risk/harm.	T2: up to 3 weeks
Secondary	Well-being and Mental Health	Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report measure of psychological distress designed to be administered during a course of treatment to determine treatment response. It compries 34 questions about how the participants have been feeling over the last week, using a 5-point scale. The scale covers four dimensions: Subjective well-being, Problems/symptoms, Life functioning, and Risk/harm.	T3: up to 3 months
Secondary	Physical functioning and psychological well-being	Pediatric Outcomes Data Collection (PODCI) evaluates functional health status through an 83-item questionnaire, and consists of scores on seven core scales, four encompassing physical function and three assessing psychological well-being.	T0: Baseline
Secondary	Physical functioning and psychological well-being	Pediatric Outcomes Data Collection (PODCI) evaluates functional health status through an 83-item questionnaire, and consists of scores on seven core scales, four encompassing physical function and three assessing psychological well-being.	T1: up to 2 weeks
Secondary	Physical functioning and psychological well-being	Pediatric Outcomes Data Collection (PODCI) evaluates functional health status through an 83-item questionnaire, and consists of scores on seven core scales, four encompassing physical function and three assessing psychological well-being.	T2: up to 3 weeks
Secondary	Physical functioning and psychological well-being	Pediatric Outcomes Data Collection (PODCI) evaluates functional health status through an 83-item questionnaire, and consists of scores on seven core scales, four encompassing physical function and three assessing psychological well-being.	T3: up to 3 months