UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039908
Receipt number R000045516
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
Date of disclosure of the study information 2020/06/01
Last modified on 2021/09/24 17:05:49

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045516


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name