UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056214 |
|---|---|
| Receipt number | R000064226 |
| Scientific Title | A Study on Effective Interventions for Recovery of Hand Function after Stroke |
| Date of disclosure of the study information | 2024/11/20 |
| Last modified on | 2024/11/20 14:41:23 |
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Basic information
Public title
A Study on Effective Interventions for Recovery of Hand Function after Stroke
Acronym
A Study on Effective Interventions for Recovery of Hand Function after Stroke
Scientific Title
A Study on Effective Interventions for Recovery of Hand Function after Stroke
Scientific Title:Acronym
A Study on Effective Interventions for Recovery of Hand Function after Stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to examine the therapeutic effects of Electrical Neuro-Muscular Stimulation (EMS) alone and Mirror Therapy (MT) combined with EMS.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brunnstrom stage, FMA (Fugel-Meyer Assessment), BBT (Building Block Transfer Test)
TAM (total active motion), TPD (tip palm distance), A-ROM (active range of motion), P-ROM (passive range of motion)
Electromyography
SWME(The Semmes Weinstein monofilament examination)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Electrical Neuro-Muscular Stimulation (EMS)
Interventions/Control_2
Electrical Neuro-Muscular Stimulation (EMS)+Mirror Therapy (MT)
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with a first stroke.
Patients with severe to moderate motor paralysis of the fingers (Brunnstrom stage I to IV).
Key exclusion criteria
Patients with poor general condition or clearly impaired consciousness.
Patients with contraindications to general electrostimulation therapy (People with internal metals, especially pacemakers, and those with serious heart disease)
* Patients with severe sensory deficits should be careful in setting the intensity.
Patients who show cognitive decline, higher brain dysfunction, visual impairment, or hearing impairment to the extent that it is difficult to perform tasks.
Patients with good separation of fingers (Brunnstrom stage V to VI).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | YUINE |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki 300-0394, Japan
TEL
0298402220
yuinehi@ipu.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | YUINE |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Department of Occupational Therapy
Zip code
300-0394
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki 300-0394, Japan
TEL
0298402220
Homepage URL
yuinehi@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Hiroshi YUINE
Funding Source
Organization
Ibaraki Prefectural University of Health Sciences
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Please Select
Other related organizations
Co-sponsor
Tokyo Medical University Ibaraki Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ibaraki Prefectural University of Health Sciences Institutional Review Board
Address
4669-2 Ami, Ami-machi, Inashiki-gun, Ibaraki
Tel
029-840-4000
yuinehi@ipu.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
東京医科大学茨城医療センター（茨城県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 11 | Month | 20 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
0
Results
N/A
Results date posted
| 2024 | Year | 11 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
N/A
Outcome measures
N/A
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2015 | Year | 11 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study was conducted before clinical trial registration, and retrospectively registered.
Management information
Registered date
| 2024 | Year | 11 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064226
