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Completed

NCT Number: NCT06397443

Ready to Sail: Evaluating Sailing's Feasibility as Ergotherapy

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

5-day sailing activity

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

Primary outcomes

  1. Health-related Quality of Life

    Time frame: T0: Baseline

    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").

  2. Health-related Quality of Life

    Time frame: T1: up to 2 weeks

    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").

  3. Health-related Quality of Life

    Time frame: T2: up to 3 weeks

    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").

  4. Health-related Quality of Life

    Time frame: 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").

Secondary outcomes

  1. Self-esteem

    Time frame: T0: Baseline

    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.

  2. Self-esteem

    Time frame: T1: up to 2 weeks

    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.

  3. Self-esteem

    Time frame: T2: up to 3 weeks

    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.

  4. Self-esteem

    Time frame: T3: up to 3 months

    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.

  5. Motor Coordination

    Time frame: T0: Baseline

    Performance Oriented Mobility Assesment (Tinetti Balance Scale) is an administered 16-item task-oriented test that measures gait and balance abilities, primarily to assess fall risk. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16. The total score (Fall Risk) ranges from 0 to 28, with higher scores indicating better balance and gait performance (19 or below=High risk of falls; 20-23=Moderate risk of falls; 24-28=Low risk of falls).

  6. Motor Coordination

    Time frame: T1: up to 2 weeks

    Performance Oriented Mobility Assesment (Tinetti Balance Scale) is an administered 16-item task-oriented test that measures gait and balance abilities, primarily to assess fall risk. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16. The total score (Fall Risk) ranges from 0 to 28, with higher scores indicating better balance and gait performance (19 or below=High risk of falls; 20-23=Moderate risk of falls; 24-28=Low risk of falls).

  7. Motor Coordination

    Time frame: T2: up to 3 weeks

    Performance Oriented Mobility Assesment (Tinetti Balance Scale) is an administered 16-item task-oriented test that measures gait and balance abilities, primarily to assess fall risk. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16. The total score (Fall Risk) ranges from 0 to 28, with higher scores indicating better balance and gait performance (19 or below=High risk of falls; 20-23=Moderate risk of falls; 24-28=Low risk of falls).

  8. Motor Coordination

    Time frame: T3: up to 3 months

    Performance Oriented Mobility Assesment (Tinetti Balance Scale) is an administered 16-item task-oriented test that measures gait and balance abilities, primarily to assess fall risk. It uses a 3-point ordinal scale of 0, 1 and 2. Gait is scored over 12 and balance is scored over 16. The total score (Fall Risk) ranges from 0 to 28, with higher scores indicating better balance and gait performance (19 or below=High risk of falls; 20-23=Moderate risk of falls; 24-28=Low risk of falls).

  9. Balance

    Time frame: T0: Baseline

    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 total score ranges from 0 to 56, with higher scores indicating better balance. A score of less than 45 suggests an increased risk of falling.

  10. Balance

    Time frame: T1: up to 2 weeks

    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 total score ranges from 0 to 56, with higher scores indicating better balance. A score of less than 45 suggests an increased risk of falling.

  11. Balance

    Time frame: T2: up to 3 weeks

    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 total score ranges from 0 to 56, with higher scores indicating better balance. A score of less than 45 suggests an increased risk of falling.

  12. Balance

    Time frame: T3: up to 3 months

    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 total score ranges from 0 to 56, with higher scores indicating better balance. A score of less than 45 suggests an increased risk of falling.

  13. Kinesiophobia

    Time frame: T0: Baseline

    The Tampa Scale for Kinesiophobia (TSK) is a validated self-report questionnaire designed to assess the fear of movement or (re)injury in individuals experiencing pain or musculoskeletal disorders. The TSK consists of 13 items (Italian validated version), each rated on a 4-point Likert scale, ranging from 1 ("Strongly Disagree") to 4 ("Strongly Agree"). The scores are summed to yield a total score ranging from 13 to 52, with higher scores indicating greater levels of kinesiophobia.

    The TSK includes two subscales: 1.Activity Avoidance, with a score ranging from 6 to 24; 2.Harm Beliefs, with a score ranging from 7 to 28.

    Higher scores on both the Activity Avoidance and Harm Beliefs subscales indicate greater levels of kinesiophobia, reflecting increased fear of movement due to injury concerns (Activity Avoidance subscale) or harmful beliefs about physical activity (Harm Beliefs subscale).

  14. Kinesiophobia

    Time frame: T2: up to 3 weeks

    The Tampa Scale for Kinesiophobia (TSK) is a validated self-report questionnaire designed to assess the fear of movement or (re)injury in individuals experiencing pain or musculoskeletal disorders. The TSK consists of 13 items (Italian validated version), each rated on a 4-point Likert scale, ranging from 1 ("Strongly Disagree") to 4 ("Strongly Agree"). The scores are summed to yield a total score ranging from 13 to 52, with higher scores indicating greater levels of kinesiophobia.

    The TSK includes two subscales: 1.Activity Avoidance, with a score ranging from 6 to 24; 2.Harm Beliefs, with a score ranging from 7 to 28.

    Higher scores on both the Activity Avoidance and Harm Beliefs subscales indicate greater levels of kinesiophobia, reflecting increased fear of movement due to injury concerns (Activity Avoidance subscale) or harmful beliefs about physical activity (Harm Beliefs subscale).

  15. Kinesiophobia

    Time frame: T3: up to 3 months

    The Tampa Scale for Kinesiophobia (TSK) is a validated self-report questionnaire designed to assess the fear of movement or (re)injury in individuals experiencing pain or musculoskeletal disorders. The TSK consists of 13 items (Italian validated version), each rated on a 4-point Likert scale, ranging from 1 ("Strongly Disagree") to 4 ("Strongly Agree"). The scores are summed to yield a total score ranging from 13 to 52, with higher scores indicating greater levels of kinesiophobia.

    The TSK includes two subscales: 1.Activity Avoidance, with a score ranging from 6 to 24; 2.Harm Beliefs, with a score ranging from 7 to 28.

    Higher scores on both the Activity Avoidance and Harm Beliefs subscales indicate greater levels of kinesiophobia, reflecting increased fear of movement due to injury concerns (Activity Avoidance subscale) or harmful beliefs about physical activity (Harm Beliefs subscale).

  16. Well-being and Mental Health

    Time frame: T0: Baseline

    Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report questionnaire designed to assess psychological distress and monitor treatment response. It consists of 34 items evaluating emotional state and perceived well-being over the past week, rated on a 5-point Likert scale from 0 ("Not at all") to 4 ("Most or all of the time").

    The total score is calculated as the mean of all item scores and can be reported in two ways: 1.Raw score: The mean of all item scores (range: 0-4). 2.Standardized score: Obtained by multiplying the raw score by 10, yielding a scale from 0 to 40.

    The data presented in the results refer to the raw score.

    Score Interpretation:

    0.00-0.99: No clinical distress or minimal risk. 1.00-1.99: Mild distress, potentially significant. 2.00-2.99: Moderate distress, generally indicative of the need for intervention.

    3.00-4.00: Severe distress, highly indicative of the need for immediate clinical intervention.

  17. Well-being and Mental Health

    Time frame: T2: up to 3 weeks

    Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report questionnaire designed to assess psychological distress and monitor treatment response. It consists of 34 items evaluating emotional state and perceived well-being over the past week, rated on a 5-point Likert scale from 0 ("Not at all") to 4 ("Most or all of the time").

    The total score is calculated as the mean of all item scores and can be reported in two ways: 1.Raw score: The mean of all item scores (range: 0-4). 2.Standardized score: Obtained by multiplying the raw score by 10, yielding a scale from 0 to 40.

    The data presented in the results refer to the raw score.

    Score Interpretation:

    0.00-0.99: No clinical distress or minimal risk. 1.00-1.99: Mild distress, potentially significant. 2.00-2.99: Moderate distress, generally indicative of the need for intervention.

    3.00-4.00: Severe distress, highly indicative of the need for immediate clinical intervention.

  18. Well-being and Mental Health

    Time frame: T3: up to 3 months

    Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM) is a self-report questionnaire designed to assess psychological distress and monitor treatment response. It consists of 34 items evaluating emotional state and perceived well-being over the past week, rated on a 5-point Likert scale from 0 ("Not at all") to 4 ("Most or all of the time").

    The total score is calculated as the mean of all item scores and can be reported in two ways: 1.Raw score: The mean of all item scores (range: 0-4). 2.Standardized score: Obtained by multiplying the raw score by 10, yielding a scale from 0 to 40.

    The data presented in the results refer to the raw score.

    Score Interpretation:

    0.00-0.99: No clinical distress or minimal risk. 1.00-1.99: Mild distress, potentially significant. 2.00-2.99: Moderate distress, generally indicative of the need for intervention.

    3.00-4.00: Severe distress, highly indicative of the need for immediate clinical intervention.

  19. Physical Functioning and Psychological Well-being

    Time frame: T0: Baseline

    Pediatric Outcomes Data Collection (PODCI) evaluates functional health status through an 83-item questionnaire, and uses domain-specific scales. Each scale generates a score ranging from 0 to 100, with higher scores indicating better functioning or less impairment.

  20. Physical Functioning and Psychological Well-being

    Time frame: T1: up to 2 weeks

    Pediatric Outcomes Data Collection (PODCI) evaluates functional health status through an 83-item questionnaire, and uses domain-specific scales. Each scale generates a score ranging from 0 to 100, with higher scores indicating better functioning or less impairment.

  21. Physical Functioning and Psychological Well-being

    Time frame: T2: up to 3 weeks

    Pediatric Outcomes Data Collection (PODCI) evaluates functional health status through an 83-item questionnaire, and uses domain-specific scales. Each scale generates a score ranging from 0 to 100, with higher scores indicating better functioning or less impairment.

  22. Physical Functioning and Psychological Well-being

    Time frame: T3: up to 3 months

    Pediatric Outcomes Data Collection (PODCI) evaluates functional health status through an 83-item questionnaire, and uses domain-specific scales. Each scale generates a score ranging from 0 to 100, with higher scores indicating better functioning or less impairment.

Other outcomes

  1. Information on the Functioning and Disability of an Individual

    Time frame: T0

    Functional Independence Measure (FIM) is a validated clinician-administered tool designed to assess functional independence in individuals with neurological or musculoskeletal conditions. It evaluates the level of assistance required for daily activities across six domains: self-care, sphincter control, mobility, locomotion, communication, and social cognition. The FIM consists of 18 items, each rated on a 7-point ordinal scale (1 = total assistance, 7 = complete independence), with total scores ranging from 18 to 126. Higher scores indicate greater functional independence.

  2. Information on the Functioning and Disability of an Individual

    Time frame: T3

    Functional Independence Measure (FIM) is a validated clinician-administered tool designed to assess functional independence in individuals with neurological or musculoskeletal conditions. It evaluates the level of assistance required for daily activities across six domains: self-care, sphincter control, mobility, locomotion, communication, and social cognition. The FIM consists of 18 items, each rated on a 7-point ordinal scale (1 = total assistance, 7 = complete independence), with total scores ranging from 18 to 126. Higher scores indicate greater functional independence.

  3. Kinesiophobia

    Time frame: T1

    The Tampa Scale for Kinesiophobia (TSK) is a validated self-report questionnaire designed to assess the fear of movement or (re)injury in individuals experiencing pain or musculoskeletal disorders. The TSK consists of 13 items (Italian validated version), each rated on a 4-point Likert scale, ranging from 1 ("Strongly Disagree") to 4 ("Strongly Agree"). The scores are summed to yield a total score ranging from 13 to 52, with higher scores indicating greater levels of kinesiophobia.

    The TSK includes two subscales: 1.Activity Avoidance, with a score ranging from 6 to 24; 2.Harm Beliefs, with a score ranging from 7 to 28.

    Higher scores on both the Activity Avoidance and Harm Beliefs subscales indicate greater levels of kinesiophobia, reflecting increased fear of movement due to injury concerns (Activity Avoidance subscale) or harmful beliefs about physical activity (Harm Beliefs subscale).

  4. Well-being and Mental Health

    Time frame: T1

    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 Likert scale ranging from 0 ("Not at all") to 4 ("Most or all of the time"). The total score is calculated as the mean of all item scores (ranging from 0 to 4) and can be reported either as a raw score or standardized (e.g., multiplying the mean by 10 to obtain a score on a 0-40 scale).

    Score Interpretation:

    0-0.99: No clinical distress or minimal risk. 1.00-1.99: Mild distress, potentially significant. 2.00-2.99: Moderate distress, generally indicative of a need for intervention. 3.00-4.00: Severe distress, highly indicative of immediate clinical intervention.

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Registry information

Official study 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

Acronym: PaS

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 2, 2024
Registry last updated
Mar 21, 2025

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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