UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030594 |
|---|---|
| Receipt number | R000034926 |
| Scientific Title | Combined effect of motor imagery and peripheral nerve electrical stimulation in patients with stroke: single-blind random control trial |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2023/08/01 22:13:45 |
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Basic information
Public title
Combined effect of motor imagery and peripheral nerve electrical stimulation in patients with stroke: single-blind random control trial
Acronym
Effect of motor imagery and peripheral nerve electrical stimulation: RCT study
Scientific Title
Combined effect of motor imagery and peripheral nerve electrical stimulation in patients with stroke: single-blind random control trial
Scientific Title:Acronym
Effect of motor imagery and peripheral nerve electrical stimulation: RCT study
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to elucidate the effect of combination peripheral nerve electrical stimulation and motor imagery on the functional recovery in stroke patients by single-blind randomized control trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II,III
Assessment
Primary outcomes
Fugl-Meyer assessment, Surface EMG of the extensor digitorum communis muscle and the flexor digitorum superficialis.
Key secondary outcomes
Reciprocal inhibition between flexor muscle and extensor muscle, Wolf Motor Function Test, Modified Ashworth Scale, Motor Activity Log, Range of Motion of finger joint (active and passive).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
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
| Maneuver |
Interventions/Control_1
Combination motor imagery and peripheral nerve electrical stimulation for 7 days
Interventions/Control_2
Motor imagery training for 7 days
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 patients with hemiparesis;
more than 150 days had passed since stroke;
no cognitive deficits;
passive extension range of motion
(ROM) greater than -30 degrees for the affected MP joint;
Finger test score on Stroke Impairment Assessment Set is 1A
Key exclusion criteria
Severe heart disease;
Severe hypertension;
Acute fever;
Severe renal failure;
Severe liver disease;
History of major psychiatric or previous
neurological diseases, including seizures;
Apraxia of paretic finger;
Cardiac pacemaker
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiyuki Kawakami |
Organization
Keio university School of Medicine
Division name
Drepartment of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL
03-5363-3833
michiyukikawakami@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiyuki Kawakami |
Organization
Keio university School of Medicine
Division name
Drepartment of Rehabilitation Medicine
Zip code
Address
35 Shinanomachi, Shinjuku, Tokyo 160-8582, Japan
TEL
03-5363-3833
Homepage URL
michiyukikawakami@hotmail.com
Sponsor or person
Institute
Department of Rehabilitation Medicine, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 01 | Month | 01 | 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
| 2018 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 27 | Day |
Last modified on
| 2023 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034926
