UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056800 |
|---|---|
| Receipt number | R000064918 |
| Scientific Title | Development of the home rehabilitation devices and methods: small scale demonstration tests |
| Date of disclosure of the study information | 2025/01/23 |
| Last modified on | 2026/03/21 11:16:19 |
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Basic information
Public title
Development of the home rehabilitation devices
Acronym
Home rehabilitation devices
Scientific Title
Development of the home rehabilitation devices and methods: small scale demonstration tests
Scientific Title:Acronym
Development of the home rehabilitation devices and methods
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to develop a self-rehabilitation device for use in nursing care facilities for patients living at home after a stroke, and to confirm its effectiveness.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The intervention time is 60 minutes/day for 10 days. The following items will be evaluated before and after the intervention.
Fugl Meyer Asesment
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
The developed rehabilitation device consists of an arm support that allows the fingers and wrists to move freely, and a suspension device that allows the patient to move freely in space while lying or sitting. Training includes reach exercises, object manipulation, and ADL exercises such as body washing. Subjects will use the device to perform four types of interventions. Each intervention takes 15 minutes (approximately 100 repetitions including breaks), and a total of 60 minutes of 4 types of practice are performed.
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
| 20 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Those with motor paralysis of upper extremity Brunnstrom Recovery Stage 3 or higher, more than 6 months after stroke onset. The applicant must be able to understand verbal and written explanations and consent to this research. Those who are appropriate for this intervention and who can obtain the consent of the attending physician as part of normal clinical practice.
Key exclusion criteria
Those with orthopedic disease from the shoulder joint to the fingers. Those with fragile skin on their hands. Those who have severe higher brain dysfunction and are judged to have difficulty understanding and performing self-training.
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Tomokazu |
| Middle name | |
| Last name | Noma |
Organization
Nihon Fukushi University
Division name
Department of Rehabilitation, Faculty of Health Sciences
Zip code
475-0012
Address
26-2 Higashihaemicho, Handa-shi, Aichi-ken
TEL
0569-20-0111
noma@n-fukushi.ac.jp
Public contact
Name of contact person
| 1st name | Tomokazu |
| Middle name | |
| Last name | Noma |
Organization
Nihon Fukushi University
Division name
Department of Rehabilitation, Faculty of Health Sciences
Zip code
475-0012
Address
26-2 Higashihaemicho, Handa-shi, Aichi-ken
TEL
0569-20-0111
Homepage URL
noma@n-fukushi.ac.jp
Sponsor or person
Institute
Nihon Fukushi University
Institute
Department
Personal name
Funding Source
Organization
Industrial Promotion Division Next Generation Industry Office of Aichi Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nihon Fukushi University Ethics Review Committee of for Research Involving Human Subjects
Address
26-2 Higashihaemicho, Handa-shi, Aichi-ken
Tel
0569-20-0111
rinri-soudan@ml.n-fukushi.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 23 | 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
Completed
Date of protocol fixation
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 23 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 20 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 21 | Day |
Date trial data considered complete
| 2026 | Year | 03 | Month | 22 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 23 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064918
