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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015039
Receipt No. R000017498
Scientific Title Effects of patterned electrical stimulation on gait disturbance in patients with stroke.
Date of disclosure of the study information 2014/09/03
Last modified on 2018/10/14

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Basic information
Public title Effects of patterned electrical stimulation on gait disturbance in patients with stroke.
Acronym Effects of patterned electrical stimulation.
Scientific Title Effects of patterned electrical stimulation on gait disturbance in patients with stroke.
Scientific Title:Acronym Effects of patterned electrical stimulation.
Region
Japan

Condition
Condition Post-stroke patients
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine effects of patterned electrical stimulation on gait disturbance in patients with stroke.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Electrophysiological assessment
Key secondary outcomes Motor function of lower extremity, excitability of motor cortex assessed with transcranial magnetic stimulation(TMS), coherence analysis, gait analysis

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Combination of patterned electrical stimulation with voluntary contraction.
Interventions/Control_2 Combination of patterned electrical stimulation with foot orthosis.
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
80 years-old >=
Gender Male and Female
Key inclusion criteria Patients group:
Hemiparetic stroke patients with motor disability of lower extremity, over and equal to 120 days after stroke, no medical history of fracture and injury by fall within three months. FIM score of locomotion (ambulatory) is greater than 5 with/without T-cane and orthosis, FIM score of cognitive comprehension is greater than 4, SIAS position sense is greater than 0, SIAS visuospatial cognition is greater than 1, no clear cognitive dysfunction, agreement to participate in the research.

Healthy group:
A person shall not have medical history of musculoskeletal (lower extremity) and nervous system disease. Agreement to participate in the research.
Key exclusion criteria Patients group:
A person shall not have epilepsy or its previous history, implanted electronic pacing or defibrillation devices.

Patients and healthy groups:
A person shall not have contraindications to gait:
serious cardiac disease: unstable angina, myocardial infarction shortly after symptom onset, decompensated congestive heart failure, acute cor pulmonale, uncontrolled arrhythmia, serious aortic stenosis, active myocarditis, endocarditis, etc.,
uncontrolled hypertension,
acute systemic disease or fever,
complication of recent pulmonary embolism, acute cor pulmonale or serious pulmonary hypertension, complication of serious liver or renal dysfunction, complication of serious orthopedic disease which bars gait capability,
complication of serious cognitive dysfunction, other metabolic abnormality (acute thyroiditis, etc.), pregnant.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Meigen Liu
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3833
Email meigenliukeio@mac.com

Public contact
Name of contact person
1st name
Middle name
Last name Michiyuki Kawakami
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-5363-3833
Homepage URL
Email michiyukikawakami@hotmail.com

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Tokyo Bay Rehabilitation Hospital
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
2014 Year 09 Month 03 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
2014 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 04 Month 01 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
2014 Year 09 Month 03 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=R000017498

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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