UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023650 |
|---|---|
| Receipt number | R000027240 |
| Scientific Title | The effects of patterned electrical stimulation combined with voluntary contraction on spinal neural circuit in patients with stroke |
| Date of disclosure of the study information | 2016/08/17 |
| Last modified on | 2018/10/14 20:28:23 |
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Basic information
Public title
The effects of patterned electrical stimulation combined with voluntary contraction on spinal neural circuit in patients with stroke
Acronym
The effects of patterned electrical stimulation combined with voluntary contraction
Scientific Title
The effects of patterned electrical stimulation combined with voluntary contraction on spinal neural circuit in patients with stroke
Scientific Title:Acronym
The effects of patterned electrical stimulation combined with voluntary contraction
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of patterned electrical stimulation (PES) combined with voluntary contraction on spinal reciprocal inhibition in patients with stroke.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Spinal reciprocal inhibition
Key secondary outcomes
Motor function (number of ankle dorsiflexion movement, motion analysis) and surface electromyography
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
PES alone (20 minutes)
Interventions/Control_2
Voluntary contraction alone (20 minutes)
Interventions/Control_3
PES combined with voluntary contraction (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
1. Fist cerebral infarction or hemorrhage with single lesion
2. At least 180 days after the stroke
3. Able to understand daily communication
4. Stroke Impairment Assessment Set (SIAS) Foot-pat test score is in the range from 1 to 3
5. Modified Ashworth scale (MAS) score is at least 1
6. Agreement to participate in the study
Key exclusion criteria
1. Medical history of orthopedic disease of leg
2. Medical history of diabetes mellitus
3. Implanted electronic pacing or defibrillation devices
4. Receiving antispastic medication during participation in the study
5. Sensory loss on affected leg
6. Stop by primary doctor
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoko Takahashi |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
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 | |
| Middle name | |
| Last name | Yoko Takahashi |
Organization
Tokyo Bay Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
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
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
| 2016 | Year | 08 | Month | 17 | 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
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
| 2016 | Year | 07 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 11 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 17 | Day |
Last modified on
| 2018 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027240
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
