UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055615 |
|---|---|
| Receipt number | R000063557 |
| Scientific Title | Effectiveness of Step-by-step Upper Limb Functional Exercise with Hand Brain-Machine Interface for Upper Limb Paraplegia Patients after Stroke: A Historical Control Study |
| Date of disclosure of the study information | 2024/09/25 |
| Last modified on | 2025/11/17 07:00:56 |
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Basic information
Public title
Effectiveness of Step-by-step Upper Limb Functional Exercise with Hand Brain-Machine Interface for Upper Limb Paraplegia Patients after Stroke: A Historical Control Study
Acronym
Effectiveness of a Brain-Machine Interface for the Hand in Patients with Upper Limb Paralysis after Stroke
Scientific Title
Effectiveness of Step-by-step Upper Limb Functional Exercise with Hand Brain-Machine Interface for Upper Limb Paraplegia Patients after Stroke: A Historical Control Study
Scientific Title:Acronym
Effectiveness of a Brain-Machine Interface for the Hand in Patients with Upper Limb Paralysis after Stroke
Region
| Japan |
Condition
Condition
Stroke (Subacute)
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to compare the improvement in stepwise upper extremity functional practice with BMI to historical data (improvement in upper extremity function in patients admitted prior to the introduction of BMI).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fugl-Meyer Assessment (FMA) : Before intervention, 4 weeks after intervention
Key secondary outcomes
stroke impairment assessment set
modified ashworth scale
motor activity log
range of motion
event related desynchronization
surface electromyography
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1-2 weeks: Brain-Machine Interface
3-4 weeks: electromyogram-triggered / controlled NMES(EMG-NMES) or NMES
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 18 years of age or older (at the time of consent)
Patients with upper limb paralysis due to stroke
Patients with a total upper limb motor score of less than 30 on the paralyzed side FMA
Key exclusion criteria
Patients with upper limb paralysis for more than 180 days
Patients who are unable to make clear decisions
Patients with pacemakers or implantable cardioverter-defibrillators
Patients participating in other clinical trials for upper extremity paraplegia prior to study entry
Patients who have undergone botulinum therapy for spasticity of the upper limb and nerve blocks such as phenol block prior to study participation
Patients with serious diseases (e.g., complications of malignancy)
Patients who are deemed inappropriate as research subjects by the investigator or physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Tomohide |
| Middle name | |
| Last name | Shirasaka |
Organization
Hokuto Social Medical Corporation Tokachi Rehabilitation Center
Division name
Rehabilitation Division, Department of Medical
Zip code
080-0833
Address
2-1 Inadacho Kisen, Obihiro City, Hokkaido
TEL
0155-47-5700
hokutopt.takahashi@gmail.com
Public contact
Name of contact person
| 1st name | Ryosuke |
| Middle name | |
| Last name | Takahashi |
Organization
Hokuto Social Medical Corporation Tokachi Rehabilitation Center
Division name
Physical Therapy Division, Department of Rehabilitation
Zip code
080-0833
Address
2-1 Inadacho Kisen, Obihiro City, Hokkaido
TEL
0155-47-5700
Homepage URL
hokutopt.takahashi@gmail.com
Sponsor or person
Institute
Hokuto Social Medical Corporation Tokachi Rehabilitation Center
Institute
Department
Personal name
Funding Source
Organization
Non
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
medical ethics committee
Address
7-5, Inada-cho Kisen, Obihiro City, Hokkaido, Japan
Tel
0155-48-8000
crc@hokuto7.or.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
| 2024 | Year | 09 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 09 | Month | 25 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063557
