Clinical trial NCT06397443: Ready to Sail: Evaluating Sailing's Feasibility as Ergotherapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Osteochondroma
Ollier Disease
Osteogenesis Imperfecta
Keywords: Rare Diseases
QoL
Movement confidence
Mental health
Social interaction
Sailing
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health-related Quality of Life
timeFrame: T0: Baseline
measure: Health-related Quality of Life
timeFrame: T1: up to 2 weeks
measure: Health-related Quality of Life
timeFrame: T2: up to 3 weeks
measure: Health-related Quality of Life
timeFrame: T3: up to 3 months
Secondary outcomes:
measure: Self-esteem
timeFrame: T0: Baseline
measure: Self-esteem
timeFrame: T1: up to 2 weeks
measure: Self-esteem
timeFrame: T2: up to 3 weeks
measure: Self-esteem
timeFrame: T3: up to 3 months
measure: Motor Coordination
timeFrame: T0: Baseline
measure: Motor Coordination
timeFrame: T1: up to 2 weeks
measure: Motor Coordination
timeFrame: T2: up to 3 weeks
measure: Motor Coordination
timeFrame: T3: up to 3 months
measure: Balance
timeFrame: T0: Baseline
measure: Balance
timeFrame: T1: up to 2 weeks
measure: Balance
timeFrame: T2: up to 3 weeks
measure: Balance
timeFrame: T3: up to 3 months
measure: Kinesiophobia
timeFrame: T0: Baseline
measure: Kinesiophobia
timeFrame: T2: up to 3 weeks
measure: Kinesiophobia
timeFrame: T3: up to 3 months
measure: Well-being and Mental Health
timeFrame: T0: Baseline
measure: Well-being and Mental Health
timeFrame: T2: up to 3 weeks
measure: Well-being and Mental Health
timeFrame: T3: up to 3 months
measure: Physical Functioning and Psychological Well-being
timeFrame: T0: Baseline
measure: Physical Functioning and Psychological Well-being
timeFrame: T1: up to 2 weeks
measure: Physical Functioning and Psychological Well-being
timeFrame: T2: up to 3 weeks
measure: Physical Functioning and Psychological Well-being
timeFrame: T3: up to 3 months
Other outcomes:
measure: Information on the Functioning and Disability of an Individual
timeFrame: T0
measure: Information on the Functioning and Disability of an Individual
timeFrame: T3
measure: Kinesiophobia
timeFrame: T1
measure: Well-being and Mental Health
timeFrame: T1
Locations:
city: Bologna
country: Italy
facility: IRCCS Istituto Ortopedico Rizzoli
Study officials:
affiliation: IRCCS Istituto Ortopedico Rizzoli
name: Luca Sangiorgi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
citation: 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.