NCT06397443Completed
Ready to Sail: Evaluating Sailing's Feasibility as Ergotherapy
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
Source: ClinicalTrials.gov · Last updated 21 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 11 Apr 2024
- Start date
- 16 May 2024
- Primary completion date
- 13 Sept 2024
- Lead sponsor
- Istituto Ortopedico Rizzoli
- NCT number
- NCT06397443
What you commit to
- Study type: Interventional
- Participants enrolled: 8
- From 16 May 2024 to the primary completion date, 13 Sept 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Individuals who underwent surgery within the preceding 6 months.
Other illness
- Individuals undergoing diagnostic evaluation for a rare skeletal disease
Age
- Participants younger than 12 years of age.
Other
- Participants with fractures or musculoskeletal injuries sustained within the past year.
- Individuals who were unable to provide written informed consent.
Who the study is looking for
- 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.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Istituto ortopedico Rizzoli Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.