Tokyo, Feb. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060598) titled 'Surf therapy and quality of life in Japanese children and youth with developmental disabilities an exploratory pre post pilot study' on Feb. 6.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Chubu University
Condition:
Condition - Neurodevelopmental disorders (including autism spectrum disorder) and Down syndrome with intellectual disability
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to explore, in an exploratory pre post design, the association between participation in an adaptive surf therapy program in Japan and changes in parent proxy health related quality of life and weekly caregiver rated behavioral functioning among children and youth with neurodevelopmental disorders and Down syndrome with intellectual disability. Outcomes are assessed pre intervention, immediately post intervention, and at 1 month follow up.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - Adaptive surf therapy program for children and youth with developmental disabilities. The program consisted of six weekly sessions, including health checks, safety briefing, land based warm up and stepwise skill practice, supervised in-water practice, and debriefing. Individualized support was provided, with medical staff on-site for safety back-up.
Eligibility:
Age-lower limit - 18
years-old
Gender - Male and Female
Key inclusion criteria - Parents/guardians of children with intellectual disability and or developmental disabilities who participate in a surf therapy program (6 weekly sessions) delivered by The SCC Surf Therapy Japan
Aged over18 years and able to provide written informed consent
Able to complete questionnaires (KIDSCREEN-27 parent-proxy) at pre post intervention and 1 month follow up, and weekly web based ratings after each session (six assessments)
Key exclusion criteria - Unable to provide written informed consent (parent guardian)
Unable to complete questionnaires (KIDSCREEN27 parent-proxy) and or weekly web-based ratings
The child is deemed unable to participate safely in surf therapy due to medical/safety reasons (e.g., contraindications to physical activity or ocean-based activities)
Withdrawal of consent discontinuation from the study
Target Size - 10
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2025 Year 04 Month 15 Day
Date of IRB - 2025 Year 05 Month 02 Day
Anticipated trial start date - 2025 Year 05 Month 12 Day
Last follow-up date - 2025 Year 11 Month 08 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069312
Disclaimer: Curated by HT Syndication.