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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Health-related Quality of Life
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Health-related Quality of Life
时间窗: 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").
次要结局
- Self-esteem(T3: up to 3 months)
- Motor Coordination(T3: up to 3 months)
- Balance(T3: up to 3 months)
- Kinesiophobia(T3: up to 3 months)
- Well-being and Mental Health(T3: up to 3 months)
- Physical Functioning and Psychological Well-being(T3: up to 3 months)
研究者
Luca Sangiorgi
Director of the Rare Skeletal Disorders Department
Istituto Ortopedico Rizzoli