UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060371 |
|---|---|
| Receipt number | R000067939 |
| Scientific Title | A Randomized Crossover Trial to Evaluate Short-Term Neurophysiological Changes Induced by a Single Session of Hand Robotic Training in Patients with First-Ever Stroke and Hemiparesis |
| Date of disclosure of the study information | 2026/01/19 |
| Last modified on | 2026/01/15 18:02:02 |
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Basic information
Public title
A Randomized Crossover Trial to Evaluate Short-Term Neurophysiological Changes Induced by a Single Session of Hand Robotic Training in Patients with First-Ever Stroke and Hemiparesis
Acronym
HAND-Robot Study
Scientific Title
A Randomized Crossover Trial to Evaluate Short-Term Neurophysiological Changes Induced by a Single Session of Hand Robotic Training in Patients with First-Ever Stroke and Hemiparesis
Scientific Title:Acronym
HAND-Robot Study
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to clarify the immediate and sustained effects of a single session of finger robot-assisted active-assistive training on cortical excitability in chronic stroke patients. To confirm its specificity, active-assistive training involving motor intention will be compared with passive training without motor intention.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor evoked potentials measured before, immediately after, 15 minutes after, and 30 minutes after the robotic intervention.
Key secondary outcomes
Modified Ashworth Scale, Box and Block Test, and surface electromyography-based Root Mean Square of the fingers before and 30 minutes after the intervention.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Active-assistive training using a finger rehabilitation robot consists of a sequence of movements: "mass flexion -> relaxation -> mass extension -> relaxation". Each set includes 10 repetitions * 3 cycles, and a total of 4 sets are performed (120 repetitions in total). The total duration is approximately 15 minutes. The range of motion for mass flexion and extension is set to the maximum possible range without causing pain. The intervention is conducted by a board-certified rehabilitation physician or by an occupational or physical therapist with more than one year of experience in finger-robot training. Each participant receives both the active-assistive and passive training conditions once each in a crossover design. In Intervention 1, passive training is conducted after a washout period of at least one week following the active-assistive training. The intervention period is one day for each training session, excluding the washout period.
Interventions/Control_2
Active-assistive training using a finger rehabilitation robot consists of a sequence of movements: "mass flexion -> relaxation -> mass extension -> relaxation". Each set includes 10 repetitions * 3 cycles, and a total of 4 sets are performed (120 repetitions in total). The total duration is approximately 15 minutes. The range of motion for mass flexion and extension is set to the maximum possible range without causing pain. The intervention is conducted by a board-certified rehabilitation physician or by an occupational or physical therapist with more than one year of experience in finger-robot training. Each participant receives both the active-assistive and passive training conditions once each in a crossover design. In Intervention 2, active-assistive training is conducted after a washout period of at least one week following the passive training. The intervention period is one day for each training session, excluding the washout period.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with a stroke who are more than six months post-onset, aged between 18 and 80 years, and able to understand the study content and provide informed consent.
Their finger function is characterized by both collective flexion and extension being incomplete.
Key exclusion criteria
1. Difficulty understanding or performing the training due to cognitive impairment or aphasia.
2. Severe contractures with a risk of injury during wrist movement.
3. Severe wrist flexor hypertonia preventing passive movement (Modified Ashworth Scale score of 4).
4. Skin disorders at electrode attachment sites or hand unit contact areas.
5. Musculoskeletal diseases (e.g., osteoporosis or rheumatologic disorders) affecting bones or muscles.
6. Inability to elicit motor evoked potentials (MEPs).
7. Presence of metallic implants near the stimulation site (e.g., cochlear implants, intracranial clips, deep brain or vagus nerve stimulators), or implanted medical devices such as pacemakers, implantable cardioverter-defibrillators, neurostimulators, or drug infusion pumps.
8. Pregnancy or suspected pregnancy.
9. Untreated epilepsy or poorly controlled epilepsy despite medication (e.g., seizures within the past year).
10. Initiation or dose change of selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) within the past four weeks.
11. Current use of tricyclic antidepressants.
12. Severe headache defined as a Migraine Disability Assessment (MIDAS) grade III or higher.
13. History of migraine with 1 or more attacks per month in the past 12 months, or migraine with aura, when the investigator judges a high risk of attack induction.
14. Severe cardiac disease, including unstable angina, recent myocardial infarction, decompensated heart failure, acute cor pulmonale, uncontrolled arrhythmia, severe aortic stenosis, active myocarditis or endocarditis, or NYHA class III or higher heart failure.
Additionally, individuals judged by the investigators to be unsuitable due to poor general medical condition will be excluded.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | MICHIYUKI |
| Middle name | |
| Last name | KAWAKAMI |
Organization
Keio University
Division name
Department of Rehabilitation Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3833
r-suzue@keio.jp
Public contact
Name of contact person
| 1st name | RAY |
| Middle name | |
| Last name | SUZUE |
Organization
Keio Univeraity
Division name
Department of Rehabilitation Medicine
Zip code
1608582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
TEL
03-5363-3833
Homepage URL
r-suzue@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
MICHIYUKI KAWAKAMI
Funding Source
Organization
Keio 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
Keio University School of Medicine Ethics Committee
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan
Tel
0333531211
med-nintei-jimu@adst.keio.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
慶應義塾大学病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 01 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067939
