UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051773 |
|---|---|
| Receipt number | R000058877 |
| Scientific Title | The effects of a collaborative program making assistive devices using 3D printing technology between patient and occupational therapist after stroke |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2024/01/31 11:40:02 |
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Basic information
Public title
The effects of a collaborative program making assistive devices using 3D printing technology between patient and occupational therapist after stroke
Acronym
The effects of a collaborative program making assistive devices using 3D printing technology
Scientific Title
The effects of a collaborative program making assistive devices using 3D printing technology between patient and occupational therapist after stroke
Scientific Title:Acronym
The effects of a collaborative program making assistive devices using 3D printing technology
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to clarify the usefulness of a new intervention strategy in improving motivation and depressive symptoms after stroke using 3D printing technology
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Apacy scale
Key secondary outcomes
The Japanese version of the Patient Health Questionnaire-9
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Collaborative program making assistive devices using 3D printing technology
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adults over the age of 18 with a diagnosis of stroke and prescribed rehabilitation
Key exclusion criteria
1)Patients who have a history of stroke in the past, 2) Patients who are not independent in prehospital ADL, 3) Patients who cannot perform evaluation, 4) patients who cannot obtain informed consent.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Kondo |
Organization
Gunma Paz university
Division name
Department of Occupational Therapy Faculty of Rehabilitation
Zip code
3700006
Address
1-7-1,tonya,Takasaki, Gunma
TEL
0273653366
kenkondoot@gmail.com
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Kondo |
Organization
Gunma Paz University
Division name
Department of Occupational Therapy Faculty of Rehabilitation
Zip code
3700006
Address
1-7-1,tonya,Takasaki, Gunma
TEL
09084650155
Homepage URL
kenkondoot@gmail.com
Sponsor or person
Institute
Gunma Paz University
Institute
Department
Personal name
Funding Source
Organization
Gunma Paz university
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
Gunma Paz University
Address
Takasaki city, tonya 1-7-1
Tel
0273653366
kenkondoot@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
| 2023 | Year | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 08 | Month | 01 | Day |
Last modified on
| 2024 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058877
