UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049655 |
|---|---|
| Receipt number | R000056547 |
| Scientific Title | Effectiveness of Voice Guidance Device for Stroke Left Hemiplegics Who Forget to Operate Wheelchair Brakes and Foot Supports -Focusing on the Effectiveness of Immediate and Continuous Use- |
| Date of disclosure of the study information | 2022/12/01 |
| Last modified on | 2025/08/13 15:04:30 |
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Basic information
Public title
Effectiveness of Voice Guidance Device for Stroke Left Hemiplegics Who Forget to Operate Wheelchair Brakes and Foot Supports
-Focusing on the Effectiveness of Immediate and Continuous Use-
Acronym
Effectiveness of Voice Guidance Device for Stroke Left Hemiplegics Who Forget to Operate Wheelchair Brakes and Foot Supports
-Focusing on the Effectiveness of Immediate and Continuous Use-
Scientific Title
Effectiveness of Voice Guidance Device for Stroke Left Hemiplegics Who Forget to Operate Wheelchair Brakes and Foot Supports
-Focusing on the Effectiveness of Immediate and Continuous Use-
Scientific Title:Acronym
Effectiveness of Voice Guidance Device for Stroke Left Hemiplegics Who Forget to Operate Wheelchair Brakes and Foot Supports
-Focusing on the Effectiveness of Immediate and Continuous Use-
Region
| Japan |
Condition
Condition
stroke left hemiplegia
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify whether the number of left hemiplegics who can operate the brake and foot support by verbal instructions increases compared to those without voice guidance devices, and whether continuous use of voice guidance devices leads to acquisition of brake and foot support operation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Study 1: (1) apply the left brake, (2) apply the right brake, (3) lower the foot from the left foot support to the floor, and (4) raise the left foot support.
Study 2: The long-term effect was measured as the percentage of the number of the above four items completed in the daily survey.
Key secondary outcomes
･Subjective evaluation (4-point Likert scale)
･The assessment of higher brain function(MMSE-J, TMT-A&B, PositionStrooptest, KF-NAP)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Study 1: Participants performed the four actions of the wheelchair device with and without the voice-guided device: left brake, right brake, left foot down, and left foot support up.
Study 2: Participants will perform the four movements of Study 1 with and without the voice guidance device for 10 days each.
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
| 40 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Those who can hold a basic conversation
(2) who are left hemiplegic and use a wheelchair
(3) The patient forgets to perform transfer preparation movements without verbal instructions (the patient failed at least one out of four transfer preparation movements for three consecutive days).
(4) Those who need verbal instructions for transfer preparation movements.
(5) The patient is able to perform the transfer operation with supervision.
Key exclusion criteria
(1)Right hemiplegic
(2) Hearing impaired
(3) Aphasia
(4) Persons with severe cognitive impairment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Tsubasa |
| Middle name | |
| Last name | Togashi |
Organization
Nakaizu rehabilitation center
Division name
Rehabilitation Department/Occupational Therapy
Zip code
410-2507
Address
108-1523,Hiekawa,Nakaizu city,Shizuoka
TEL
0558-83-2111
22S1107@g.iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Togashi |
Organization
Nakaizu rehabilitation center
Division name
Rehabilitation Department/Occupational Therapy
Zip code
410-2507
Address
108-1523,Hiekawa,Nakaizu city,Shizuoka
TEL
0558-83-2111
Homepage URL
22S1107@g.iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
1-2-25, Shiroyama, Odawara city, Kanagawa
Tel
0465-21-6500
g-deguchi@iuhw.ac.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
中伊豆リハビリテーションセンター
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
https://resja.or.jp/conf-38/proceeding/
Publication of results
Published
Result
URL related to results and publications
https://resja.or.jp/conf-38/proceeding/
Number of participants that the trial has enrolled
12
Results
In Study 1, 10 stroke wheelchair users (who routinely forgot to operate brakes, etc.) used the device, resulting in a reduction in the number of items forgotten compared to the number of items forgotten in daily life. In Study 2, two stroke wheelchair users used the device for 10 days, and both showed effects even when not using the device after use.
Results date posted
| 2025 | Year | 08 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Study 1: 10 wheelchair users who have suffered a stroke (those who routinely forget to operate brakes, etc.) Study 2: 2 of the above
Participant flow
Recruiting at Nakaizu Rehabilitation Center
Adverse events
No particular problems
Outcome measures
About being able to operate the brakes, etc., and free comments
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 30 | Day |
Last modified on
| 2025 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056547
