UMIN-CTR Clinical Trial

Basic information
Public title	A study of transcutaneous electrical stimulation over spinal and lower limb on lower limb muscle strength in patients with stroke
Acronym	A study of transcutaneous electrical stimulation over spinal and lower limb
Scientific Title	The combined effects of trans-spinal direct current stimulation and neuromuscular electrical stimulation on lower limb muscle strength in patients with stroke
Scientific Title:Acronym	The combined effects of trans-spinal direct current stimulation and neuromuscular electrical stimulation
Region	Japan

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

Objectives
Narrative objectives1	The study is to investigate the combined effects of trans-spinal direct current stimulation and neuromuscular electrical stimulation on muscle strength recovery in patients with stroke
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Muscle strength of ankle dorsiflexion on affected side
Key secondary outcomes	Motor function of lower extremity Gait ability Surface electromyography Gait analysis

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	tsDCS and NMES (20 minutes, 15 sessions)
Interventions/Control_2	tsDCS and sham NMES (20 minutes, 15 sessions)
Interventions/Control_3	Sham tsDCS and NMES (20minutes, 15 sessions)
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	40 years-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	1) First episode of unilateral hemiparetic stroke occurring within the six-month period prior to enrolment 2) Stroke Impairment Assessment Scale Foot-pat-test score more than 1 3) No severe cognitive impairment (Mini-Mental State Examination: MMSE>24)
Key exclusion criteria	1) Sensory loss on affected side 2) Difficult to daily communication 3) Implanted electronic pacing or defibrillation devices 4) Sever internal and/or musculoskeletal disorders 5) Sever higher brain dysfunction and/or mental illness
Target sample size	45

Research contact person
Name of lead principal investigator	1st name Tadaki Middle name Last name Koseki
Organization	Yamagata saisei hospital
Division name	Department of Rehabilitation
Zip code	990-8545
Address	79-1, Okimachi, Yamagata-shi, Yamagata
TEL	023-682-1111
Email	d.tadaki.koseki@yachts.ac.jp

Public contact
Name of contact person	1st name Tadaki Middle name Last name Koseki
Organization	Yamagata saisei hospital
Division name	Department of Rehabilitation
Zip code	990-8545
Address	79-1, Okimachi, Yamagata-shi, Yamagata
TEL	023-682-1111
Homepage URL
Email	d.tadaki.koseki@yachts.ac.jp

Sponsor
Institute	Yamagata saisei hospital, Department of Rehabilitation
Institute
Department

Funding Source
Organization	Self funding
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	Yamagata saisei hospital
Address	79-1, Okimachi, Yamagata-shi, Yamagata
Tel	023-682-1111
Email	d.tadaki.koseki@yachts.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	済生会山形済生病院（山形県）

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 09 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	Enrolling by invitation
Date of protocol fixation	2021 Year 01 Month 10 Day
Date of IRB	2021 Year 02 Month 19 Day
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2026 Year 03 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	2021 Year 03 Month 09 Day
Last modified on	2021 Year 03 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049759