UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060462 |
|---|---|
| Receipt number | R000069090 |
| Scientific Title | Effect of an Educational Intervention on Medical Device Related Pressure Ulcers Associated with Lower-Limb Orthoses: A Quasi Experimental Study Using a Waitlist Control Design |
| Date of disclosure of the study information | 2026/02/03 |
| Last modified on | 2026/02/02 22:06:56 |
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Basic information
Public title
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
Acronym
Educational Intervention for Orthosis Related Medical Device Related Pressure Ulcers
Scientific Title
Effect of an Educational Intervention on Medical Device Related Pressure Ulcers Associated with Lower-Limb Orthoses: A Quasi Experimental Study Using a Waitlist Control Design
Scientific Title:Acronym
Orthosis-Related Medical Device Related Pressure Ulcer Educational Intervention Study
Region
| Japan |
Condition
Condition
Medical device related pressure ulcers
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Awareness and subjective knowledge regarding MDRPU, as well as self-efficacy for MDRPU prevention
Key secondary outcomes
Changes in preventive behaviours related to MDRPU during the post-training follow-up period
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
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).
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | 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 sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hideyuki |
| Middle name | |
| Last name | Ogawa |
Organization
Saitama Rehabilitation Centre
Division name
Department of Physiotherapy
Zip code
362-0057
Address
148-1 Nishi-Beizuka, Omiya, Saitama Prefecture
TEL
048-781-2222
number.e.ight888@gmail.com
Public contact
Name of contact person
| 1st name | Hideyuki |
| Middle name | |
| Last name | Ogawa |
Organization
Saitama Rehabilitation Centre
Division name
Department of Physiotherapy
Zip code
362-0057
Address
148-1 Nishi-Beizuka, Omiya, Saitama Prefecture
TEL
048-781-2222
Homepage URL
jatpt.14th.forum@gmail.com
Sponsor or person
Institute
Japanese Society of Assistive Technology in Physical Therapy
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University of Science
Address
4-1, 15chome, Maeda 7jo, Teine Ward, Sapporo City, Hokkaido
Tel
011-681-2161
jatpt.14th.forum@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 25 | Day |
Last modified on
| 2026 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069090
