UMIN-CTR Clinical Trial

Basic information
Public title	The effects of gait training combined with electromyography-triggered neuromuscular electrical stimulation on hip abductor and ankle dorsiflexor muscles in patients with stroke
Acronym	The effects of gait training combined with electromyography-triggered neuromuscular electrical stimulation in patients with stroke
Scientific Title	The effects of gait training combined with electromyography-triggered neuromuscular electrical stimulation on hip abductor and ankle dorsiflexor muscles in patients with stroke
Scientific Title:Acronym	The effects of gait training combined with electromyography-triggered neuromuscular electrical stimulation in patients with stroke
Region	Japan

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

Objectives
Narrative objectives1	This study investigated whether gait training combined with electromyography-triggered neuromuscular electrical stimulation on hip abductor and ankle dorsiflexor muscles affected stroke patients' gait performance.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	10-meter walking test trunk acceleration
Key secondary outcomes	fugl-meyer assessment (the lower extremity) stroke impairment assessment set (foot-pat test) modified ashworth scale

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	gait training with electromyography-triggered neuromuscular electrical stimulation on hip abductor and ankle dorsiflexor muscles
Interventions/Control_2	gait training with electromyography-triggered neuromuscular electrical stimulation on ankle dorsiflexor muscle
Interventions/Control_3	gait training
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Consent to participate in the study 2) The ability to walk without support for at least 10-meters 3) The score of SIAS foot-pat test is 1 or more 4) Capability of communicating and understanding instructions
Key exclusion criteria	1) Contraindications for electrical stimulation 2) Severe sensory deficits 3) Neurological condition unrelated to stroke hemiparesis
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Tsubasa Middle name Last name Mitsutake
Organization	Fukuoka International University of Health and Welfare
Division name	Department of Physical Therapy, Faculty of Medicine
Zip code	814-0001
Address	3-6-40 Momochihama, Sawara, Fukuoka
TEL	092-832-1200
Email	t-mitsutake@takagigakuen.ac.jp

Public contact
Name of contact person	1st name Tsubasa Middle name Last name Mitsutake
Organization	Fukuoka International University of Health and Welfare
Division name	Department of Physical Therapy, Faculty of Medicine
Zip code	814-0001
Address	3-6-40 Momochihama, Sawara, Fukuoka
TEL	092-832-1200
Homepage URL
Email	t-mitsutake@takagigakuen.ac.jp

Sponsor
Institute	Department of Physical Therapy, Faculty of Medicine, Fukuoka International University of Health and Welfare
Institute
Department

Funding Source
Organization	Takeda Science Foundation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Fukuoka International University of Health and Welfare
Address	3-6-40 Momochihama, Sawara, Fukuoka
Tel	092-832-1200
Email	fiuhw-rinri@takagigakuen.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 06 Month 01 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	Terminated
Date of protocol fixation	2020 Year 05 Month 01 Day
Date of IRB	2020 Year 06 Month 10 Day
Anticipated trial start date	2020 Year 06 Month 11 Day
Last follow-up date	2021 Year 05 Month 31 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 03 Month 23 Day
Last modified on	2021 Year 09 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045516