UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028087 |
|---|---|
| Receipt number | R000032152 |
| Scientific Title | The combined effects of motor imagery in lower extremity and peripheral nerve electrical stimulation on neural plasticity |
| Date of disclosure of the study information | 2017/07/05 |
| Last modified on | 2020/01/06 12:07:44 |
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Basic information
Public title
The combined effects of motor imagery in lower extremity and peripheral nerve electrical stimulation on neural plasticity
Acronym
The combined effects of motor imagery and electrical stimulation
Scientific Title
The combined effects of motor imagery in lower extremity and peripheral nerve electrical stimulation on neural plasticity
Scientific Title:Acronym
The combined effects of motor imagery and electrical stimulation
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of motor imagery combined with peripheral nerve electrical stimulation on corticospinal excitability and spinal reciprocal inhibition
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor evoked potential, spinal reciprocal inhibition
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Motor imagery alone (20 minutes)
Interventions/Control_2
Electrical stimulation alone (20 minutes)
Interventions/Control_3
Motor imagery combined with electrical stimulation (20 minutes)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Agreement to participate in the study
Key exclusion criteria
1. Medical history of orthopedic disease of leg
2. Medical history of neurological disease
3. Implanted electronic pacing or defibrillation devices
4. Medical history of epilepsy and febrile convulsion (including family history)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
275-0026
Address
4-1-1 Yatsu, Narashino-shi, Chiba
TEL
047-453-9000
matsuda_y@a6.keio.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Takahashi |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
275-0026
Address
4-1-1 Yatsu, Narashino-shi, Chiba
TEL
047-453-9000
Homepage URL
matsuda_y@a6.keio.jp
Sponsor or person
Institute
Tokyo Bay Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
Tokyo Bay Rehabilitation Hospital
Address
4-1-1 Yatsu, Narashino-shi, Chiba
Tel
0474539000
matsuda_y@a6.keio.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
| 2017 | Year | 07 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
17
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 02 | Month | 21 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 20 | 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 | 07 | Month | 05 | Day |
Last modified on
| 2020 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032152
