Tokyo, Feb. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060462) titled 'Effect of an Educational Intervention on Medical Device Related Pressure Ulcers Associated with ankle foot Orthosis: A Quasi Experimental Study Using a Waitlist Control Design' on Feb. 3.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Non-randomized Blinding - Single blind -investigator(s) and assessor(s) are blinded Control - No treatment

Primary Sponsor: Institute - Japanese Society of Assistive Technology in Physical Therapy

Condition: Condition - Medical device related pressure ulcers Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - This study aims to verify the impact of an educational intervention on Medical Device Related Pressure Ulcers (MDRPU) delivered through a society-sponsored training programe for healthcare professionals involved in the care of patients using lower-limb orthoses. The educational intervention will be compared between an immediate participation group (face-to-face training group) and a waitlist control group receiving the programe via ondemand training. The study aims to assess the effects of the intervention on: Awareness and subjective knowledge regarding MDRPU, as well as self-efficacy for MDRPU prevention (primary outcome measures), Changes in preventive behaviours related to MDRPU during the post-training follow-up period (secondary outcome measures). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - The group receiving immediate educational intervention on pressure ulcers related to lower limb orthoses and associated medical devices (face-to-face participants constitute the group receiving immediate educational intervention, with assessments conducted at three time points: pre-training (T0), immediately post-training (T1), and one month post-training (T2)) Interventions/Control_2 - Participants in the on-demand training programme will be assigned a one month waiting period between the conclusion of the forum and the commencement of on-demand training. During this period (prior to training commencement), assessments equivalent to those conducted for face-to-face participants (T0, T1) will be administered at the same time points (W0, W1). The waiting period is designated as a non-intervention control period. Subsequently, assessments are conducted before the on-demand training commences (D0), immediately after the training concludes (D1), and one month after the training concludes (D2).

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1) Adult between 18 and 65 years 2) Healthcare professionals (e.g., physical therapists, occupational therapists, nurses, orthotists, or other allied health professionals, and students). 3) Ability to complete web-based questionnaires at multiple assessment time points during the study period. Key exclusion criteria - 1) Failure to provide informed consent to participate in the study. 2) Inability to complete web-based questionnaires at the required assessment time points (e.g., due to lack of internet access or technical difficulties). 3) Non-participation in the society-sponsored MDRPU training programme, including failure to attend the face-to-face training or to access the on-demand training during the designated period. 4) Incomplete baseline assessment prior to the educational intervention. Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 01 Day Date of IRB - 2026 Year 01 Month 30 Day Anticipated trial start date - 2026 Year 03 Month 01 Day Last follow-up date - 2026 Year 04 Month 07 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069090

Disclaimer: Curated by HT Syndication.