Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06397443
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-04-11
Brief Title:
Ready to Sail Evaluating Sailings Feasibility as Ergotherapy
Sponsor:
Istituto Ortopedico Rizzoli
Organization:
Istituto Ortopedico Rizzoli
Study Overview
Official Title:
Pronti A Salpare Studio di fattibilità SullImpatto Della Vela Come Ergoterapia in Pazienti Con Malattie Rare Scheletriche - Ready to Sail Evaluating Sailings Feasibility as Ergotherapy for Rare Skeletal Diseases
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PaS
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None