UMIN-CTR Clinical Trial

Basic information
Public title	Effects of repetitive facilitative exercise under continuous neuromuscular electrical stimulation for upper paretic extremity in acute phase stroke: A randomized controlled study
Acronym	Effects of repetitive facilitative exercise under electrical stimulation for upper paretic extremity
Scientific Title	Effects of repetitive facilitative exercise under continuous neuromuscular electrical stimulation for upper paretic extremity in acute phase stroke: A randomized controlled study
Scientific Title:Acronym	Effects of repetitive facilitative exercise under electrical stimulation for upper paretic extremity
Region	Japan

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

Objectives
Narrative objectives1	To examine repetitive facilitative exercise under continuous neuromuscular electrical stimulation for the upper paretic extremity in acute stroke patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Fugl-Meyer Assessment(FMA)
Key secondary outcomes	Action research arm test(ARAT), active range of motion(AROM), Motor activity log(MAL), Modified Ashworth scale(MAS), Adverse event

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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	Repetitive facilitative exercise under continuous neuromuscular electrical stimulation(RFE under cNMES). Intervention on with RFE under cNMES is scheduled 30min/day, five times a week, for 1 weeks.
Interventions/Control_2	Conventional rehabilitation therapy without neuromuscular electrical stimulation
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)patients who agree to participate in this study and provide their informed consent; (2)since after stroke within 1 weeks; (3)stroke type is only intracranial hemorrhage or ischemic stroke; (4)inpatients; (5)Brunnstrom Recovery stage is II, III, IV, V; (6)stable general condition
Key exclusion criteria	(1)severe sensory disturbance or severe ataxia or severe higher brain dysfunction or severe dementia; (2)patients whose impairment severities changed during the study period; (3)contraindicated for the electrical stimulation (e.g. patients with a medical implant or implantable medical electrical equipment such as a cardiac pacemaker)
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Hoei
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Dept. of Rehabilitation
Zip code	270-1694
Address	1715 Kamagari, Inzai, Chiba
TEL	0476-99-1111
Email	t-hoei@nms.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Hoei
Organization	Nippon Medical School Chiba Hokusoh Hospital
Division name	Dept. of Rehabilitation
Zip code	270-1694
Address	1715 Kamagari, Inzai, Chiba
TEL	0476-99-1111
Homepage URL
Email	t-hoei@nms.ac.jp

Sponsor
Institute	Nippon Medical School Chiba Hokusoh Hospital
Institute
Department

Funding Source
Organization	Non
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	Nippon Medical School Chiba Hokusoh Hospital
Address	1715 Kamagari, Inzai, Chiba
Tel	0476-99-1111
Email	t-hoei@nms.ac.jp

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 04 Month 27 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 03 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 05 Month 01 Day
Last follow-up date	2022 Year 02 Month 28 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 04 Month 25 Day
Last modified on	2020 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045905