UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of patterned electrical stimulation on gait disturbance in patients with stroke.
Title of the study (Brief title)	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	Meigen Liu
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3833
Email	meigenliukeio@mac.com

Public contact
Name of contact person	Michiyuki Kawakami
Organization	Keio University School of Medicine
Division name	Department of Rehabilitation Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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