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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023650
Receipt No. 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

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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
Email 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
Email matsuda_y@a6.keio.jp

Sponsor
Institute Tokyo Bay Rehabilitation Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027240

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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