Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055795) titled 'Effectiveness of Teaching Children Self-Directed Rehabilitation Training on the Mental and Physical Functioning of Long-Term Hospitalized Children: A Multicenter Study' on Nov. 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Single blind -investigator(s) and assessor(s) are blinded
Control - Active
Primary Sponsor:
Institute - Kyorin University School of Medicine
Condition:
Condition - disuse syndrome
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - Mission X is considered suitable as an exercise program for long-term hospitalized children because (1) it is a comprehensive learning program on the theme of space exploration and (2) it is a free, semi-public program. Therefore, we planned to investigate how the Mission X program affects the activity level and mental health of long-term hospitalized children.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - The intervention group will be introduced to Mission X and instructed to perform Mission X for at least 20 minutes per day. 5 activities in Mission X will be selected that can be practiced with hospitalized children.The intervention group will be instructed to aim for at least 20 minutes per day.
Interventions/Control_2 - The control group is introduced to the usual self-program.The control group will be instructed to aim for at least 20 minutes per day.
Eligibility:
Age-lower limit - 4
years-old
=
Gender - Male and Female
Key inclusion criteria - The target population will be children at high risk of inactivity who are referred to the rehabilitation department by their primary department, such as pediatrics, for evaluation of the need for medical rehabilitation. Indications will be determined separately from medical rehabilitation, and additional research interventions will be implemented after explanation and consent. Inclusion criteria are (1) age 4-14 years, (2) with medical rehabilitation intervention, and (3) with Internet access.
Key exclusion criteria - Exclusion criteria are (1) intellectual problems that make it difficult for the patient to perform the Mission X program or independent training, and (2) general condition that does not allow the patient to perform the task.
Target Size - 20
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2024 Year 09 Month 12 Day
Anticipated trial start date - 2024 Year 10 Month 31 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063530
Disclaimer: Curated by HT Syndication.