UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the therapeutic effects to finger function in acute stroke patients with hemiplegia using Integrated volitional control electrical stimulator(IVES).
Acronym	Investigation of the therapeutic effects to finger function in acute stroke patients with hemiplegia using Integrated volitional control electrical stimulator(IVES).
Scientific Title	Investigation of the therapeutic effects to finger function in acute stroke patients with hemiplegia using Integrated volitional control electrical stimulator(IVES).
Scientific Title:Acronym	Investigation of the therapeutic effects to finger function in acute stroke patients with hemiplegia using Integrated volitional control electrical stimulator(IVES).
Region	Japan

Condition
Condition	Stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Intervene using IVES from acute stage to examine the therapeutic effect of finger function.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fugl-Meyer Assessment
Key secondary outcomes	Brunnstrom rerovery stage Modified ashworth scale Motor Activity Log

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	IVES
Interventions/Control_2	Usual rehabilitation program alone
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1)the patient with motor disability in upper extremity,2)Those who passed within 21days since onset, 3) It is possible to detect the electromyogram of finger extension using the integrated volitional control electrical stimulation device.
Key exclusion criteria	1) severe limited range of motion in wrist,2) severe sensory disturbance , 3) severe higher brain dysfunction, 4) patients with the contraindication of electrical stimulation therapy
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hiroki Middle name Last name Kimura
Organization	Nagoya Tokushukai General Hospital
Division name	Rehabilitation
Zip code	487-0016
Address	2-52 north of Kozoji-cho,Kasugai City,Aichi Prefecture
TEL	0568-51-8711
Email	kmkmjpn@gmail.com

Public contact
Name of contact person	1st name Hiroki Middle name Last name Kimura
Organization	Nagoya Tokushukai General Hospital
Division name	Rehabilitation
Zip code	487-0016
Address	2-52 north of Kozoji-cho,Kasugai City,Aichi Prefecture
TEL	0568-51-8711
Homepage URL
Email	kmkmjpn@gmail.com

Sponsor
Institute	Nagoya Tokushukai General Hospital
Institute
Department

Funding Source
Organization	Nagoya Tokushukai General Hospital
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	Nagoya Tokushukai General Hospital
Address	2-52 north of Kozoji-cho,Kasugai City,Aichi Prefecture
Tel	0568-51-8711
Email	kmkmjpn@gmail.com

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	2020 Year 09 Month 22 Day

Related information
URL releasing protocol
Publication of results	Unpublished

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	Preinitiation
Date of protocol fixation	2020 Year 09 Month 22 Day
Date of IRB
Anticipated trial start date	2022 Year 09 Month 22 Day
Last follow-up date	2024 Year 09 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 09 Month 22 Day
Last modified on	2020 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047788