UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of patterned electrical stimulation combined with voluntary contraction on spinal neural circuit in patients with stroke
Title of the study (Brief title)	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	Yoko Takahashi
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Department of Rehabilitation
Address	4-1-1, Yatsu, Narashino-shi, Chiba
TEL	047-453-9000
Email	matsuda_y@a6.keio.jp

Public contact
Name of contact person	Yoko Takahashi
Organization	Tokyo Bay Rehabilitation Hospital
Division name	Department of Rehabilitation
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 04 Day
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

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