Tokyo, Aug. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058731) titled 'A Multi-phase Study of Non-insured Rehabilitation Service Users: Baseline Characteristics, Longitudinal Changes, and Intervention Effects' on Aug. 8.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Osaka kawasaki Rehabilitation University
Condition:
Condition - Patients with pain (acute pain, chronic pain)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To cross-sectionally analyze baseline characteristics of users of non-insured rehabilitation services, longitudinally track their changes, and implement an intervention based on identified characteristics.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Educational, Counseling, Training
Interventions/Control_2 - usual care
Eligibility:
Age-lower limit - 12
years-old
=
Gender - Male and Female
Key inclusion criteria - Individuals who have provided written informed consent for study participation
Patients with acute or chronic pain
Individuals who are independent or require only minimal assistance in activities of daily living (ADL)
Individuals deemed capable of participating in the study intervention (exercise, education, etc.)
Key exclusion criteria - Individuals with severe cognitive impairment or dementia that precludes effective communication
Individuals with severe cardiovascular, respiratory, or other serious comorbidities
Individuals for whom safe participation in the intervention is deemed difficult due to acute illness or injury
Pregnant or breastfeeding women
Any other individuals judged as inappropriate for study participation by the principal investigator
Target Size - 5000
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2025 Year 04 Month 01 Day
Date of IRB - 2023 Year 08 Month 31 Day
Anticipated trial start date - 2025 Year 08 Month 01 Day
Last follow-up date - 2028 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067157
Disclaimer: Curated by HT Syndication.