UMIN-CTR Clinical Trial

Basic information
Public title	Effect of neuromuscular electrical stimulation therapy on anticipatory postural adjustments in patients with stroke hemiplegia
Acronym	Effect of neuromuscular electrical stimulation therapy on anticipatory postural adjustments in patients with stroke hemiplegia
Scientific Title	Effect of neuromuscular electrical stimulation therapy on anticipatory postural adjustments in patients with stroke hemiplegia
Scientific Title:Acronym	Effect of neuromuscular electrical stimulation therapy on anticipatory postural adjustments in patients with stroke hemiplegia
Region	Japan

Condition
Condition	Post-Stroke Hemiplegic Patients
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of neuromuscular electrical stimulation therapy on anticipatory postural adjustments in patients with stroke hemiplegia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	gravity and accelerometer
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
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	Other
Interventions/Control_1	In addition to standard physiotherapy (flexibility increase, muscle strengthening, balance exercise, walking exercise), center of gravity movement exercise and step exercise using IVES (tibialis anterior muscle, soleus muscle stimulation) are performed for 2 groups of subjects.
Interventions/Control_2	One session is 20 minutes, 3 times a week for a total of 2 weeks.
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	45 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	Person is gait without assistance
Key exclusion criteria	Person has Serious higher brain dysfunction and tive dicline cognitive function
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tomoko Middle name Last name Sakai
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Zip code	113-8510
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	0338136111
Email	onuma.reh@tmd.ac.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Onuma
Organization	Tokyo Medical and Dental University
Division name	1-5-45 Yushima Bunkyo-ku Tokyo
Zip code	0338136111
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	0338136111
Homepage URL
Email	onuma.reh@tmd.ac.jp

Sponsor
Institute	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Address	1-5-45 Yushima Bunkyo-ku Tokyo
Tel	0338136111
Email	onuma.reh@tmd.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 11 Month 25 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 11 Month 25 Day
Date of IRB
Anticipated trial start date	2020 Year 12 Month 01 Day
Last follow-up date	2021 Year 12 Month 01 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 11 Month 25 Day
Last modified on	2020 Year 11 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048549