UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049055 |
|---|---|
| Receipt number | R000055892 |
| Scientific Title | Evaluation of the Efficacy and Safety of a Stand-Assisted Electric Wheelchair in Patients with Muscular Dystrophy |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/10/01 15:26:38 |
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Basic information
Public title
Evaluation of the Efficacy and Safety of a Stand-Assisted Electric Wheelchair in Patients with Muscular Dystrophy
Acronym
Evaluation of the Efficacy and Safety of a Stand-Assisted Electric Wheelchair in Patients with Muscular Dystrophy
Scientific Title
Evaluation of the Efficacy and Safety of a Stand-Assisted Electric Wheelchair in Patients with Muscular Dystrophy
Scientific Title:Acronym
Evaluation of the Efficacy and Safety of a Stand-Assisted Electric Wheelchair in Patients with Muscular Dystrophy
Region
| Japan |
Condition
Condition
Muscular dystrophy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effectiveness and safety of a stand-supported electric wheelchair and its effectiveness in reducing the burden of caregivers.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Independence and care prevention benefits of the standing-assistive power wheelchair
Key secondary outcomes
Efficacy in Reducing Caregiver Burden
Comfortness and physical load reduction effect
Safety and ease of function acquisition
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Standing-assist power wheelchair use
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Muscular dystrophy patients receiving outpatient care or hospitalized at collaborating institutions
Patients who are able to learn to operate a standing-assisted electric wheelchair
Written consent of the research subject
Key exclusion criteria
Patients with intellectual disabilities and are challenged to operate a standing-assistive power wheelchair safely.
Patients are considered at high risk for a standing-assistive power wheelchair due to severe heart failure, fatal arrhythmia, spinal deformity, or contracture.
Patients who are presumed to be at high risk for a standing-assistive power wheelchair due to active diseases (e.g., pneumonia)
Patients whom the principal investigator or principal investigator determines are not appropriate to participate in this study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Matsumura |
Organization
National Hospital Organization Osaka Toneyama National Hospital
Division name
Neurology
Zip code
560-8552
Address
Toneyama 5-1-1, Toyonaka, Osaka
TEL
06-6853-2001
matsumura.tsuyoshi.kq@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Matsumura |
Organization
National Hospital Organization Osaka Toneyama National Hospital
Division name
Neurology
Zip code
560-8552
Address
Toneyama 5-1-1, Toyonaka, Osaka
TEL
06-6853-2001
Homepage URL
matsumura.tsuyoshi.kq@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Osaka Toneyama National Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Osaka Toneyama Medical Center
Address
Toneyama 5-1-1, Toyonaka, Osaka
Tel
06-6853-2001
410-chiken@mail.hosp.go.jp
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
国立病院機構新潟病院
国立病院機構鈴鹿病院
国立病院機構松本医療センター
国立病院機構沖縄病院
聖マリア病院
名古屋市立大学
Other administrative information
Date of disclosure of the study information
| 2022 | 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
11
Results
Most patients were satisfied with the variety of positioning. Since this survey was limited to in-hospital use, evaluating the effectiveness in social life and its efficacy in reducing caregivers' burden was difficult. Some respondents commented that the size and weight of the wheelchair made it difficult to use at home and that it took a particular time to get used to operating it. One person who mishandled the wheelchair suffered a broken toe, but this was not due to a defect in the wheelchair.
Results date posted
| 2023 | Year | 10 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Toe fracture due to mishandling
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055892
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| Registered date | File name |
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