UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050491 |
|---|---|
| Receipt number | R000057500 |
| Scientific Title | A robotic finger training system to facilitate repetitive passive and active-assistive exercise: a feasibility study. |
| Date of disclosure of the study information | 2023/03/04 |
| Last modified on | 2026/09/04 16:24:13 |
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Basic information
Public title
A robotic finger training system to facilitate repetitive passive and active-assistive exercise: a feasibility study.
Acronym
A robotic finger training system to facilitate repetitive passive and active-assistive exercise: a feasibility study.
Scientific Title
A robotic finger training system to facilitate repetitive passive and active-assistive exercise: a feasibility study.
Scientific Title:Acronym
A robotic finger training system to facilitate repetitive passive and active-assistive exercise: a feasibility study.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the usability and feasibility of the robot under development.
Basic objectives2
Others
Basic objectives -Others
Feasibility, usability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective assessment (five scale rating)
Key secondary outcomes
1. Fugl-Meyer Assessment
2. Action Research Arm Test
3. Modified Ashworth Scale
4. Stroke Impairment Assessment Set
5. Range of motion
6. Electromyogram
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
Participants will exercise both passive and active-assistive hand movements using a hand robot.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stroke survivors with motor impairment in finger who consulted a rehabilitation department
Key exclusion criteria
1. General condition is unstable and possibility of sudden change
2. Limited range of motion in fingers or wrist
3. Cognitive impairment that interferes the exercise or objective assessment
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Otaka |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine I, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-2167
rehabmed@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Ushizawa |
Organization
Fujita Health University
Division name
Department of Rehabilitation Medicine I, School of Medicine
Zip code
470-1192
Address
1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi, Japan
TEL
0562-93-2167
Homepage URL
kazuki.ushizawa@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health 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
Institutional Review Board of Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, Japan
Tel
0562-93-2865
f-irb@fujita-hu.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
| 2023 | Year | 03 | Month | 04 | Day |
Related information
URL releasing protocol
https://www.jstage.jst.go.jp/article/fmj/12/2/12_2025-025/_article
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/fmj/12/2/12_2025-025/_article
Number of participants that the trial has enrolled
11
Results
Ten participants completed the 7-day training. For the intra-day effect, the CCI was significantly decreased immediately after training, particularly during active finger flexion, and the AROM tended to improve from the middle of the training days. For the inter-day effect, there were no significant changes in the Stroke Impairment Assessment Set for Finger Function, modified Ashworth scale, CCI, or AROM after the 7-day training.
Results date posted
| 2026 | Year | 09 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Eleven participants were enrolled between May 2023 and April 2024, including 11 individuals with subacute stroke (3 women; mean age, 62.5 y; SD, 16.2; mean days after stroke onset, 47.5 days; SD, 17.5).
Participant flow
All participants were enrolled in the rehabilitation ward in Fujita Health University Hospital between May 2023 and April 2024. All participants provided written informed consent before participation. Then, the participants performed robot-assisted active-assistive finger flexion-extension movements for 20 min daily and repeated this training on 7 non-consecutive days.
Adverse events
No adverse events occurred during the 7-day training.
Outcome measures
(1) Active range of otion
(2) Co-contraction index
(3) Stroke Impairment Assessment Set for Finger Function
(4) modified Ashworth scale
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 07 | Month | 08 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 08 | 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
| 2023 | Year | 03 | Month | 04 | Day |
Last modified on
| 2026 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057500
