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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034580
Receipt No. R000039417
Scientific Title Immediate effect of gait training with functional electrical stimulation to the tibialis anterior and the gluteus medius on the gait pattern in patients with stroke
Date of disclosure of the study information 2018/10/20
Last modified on 2019/10/24

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Basic information
Public title Immediate effect of gait training with functional electrical stimulation to the tibialis anterior and the gluteus medius on the gait pattern in patients with stroke
Acronym Immediate effect of gait training with functional electrical stimulation on the gait pattern in stroke patients
Scientific Title Immediate effect of gait training with functional electrical stimulation to the tibialis anterior and the gluteus medius on the gait pattern in patients with stroke
Scientific Title:Acronym Immediate effect of gait training with functional electrical stimulation on the gait pattern in stroke patients
Region
Japan

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

Objectives
Narrative objectives1 To determine the immediate effect of gait training with functional electrical stimulation to the tibialis anterior and the gluteus medius on the gait pattern in patients with stroke.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 10m walk test
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Gait training with functional electrical stimulation
Interventions/Control_2
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
90 years-old >
Gender Male and Female
Key inclusion criteria (1)Post-stroke hemiparesis
(2)The ability to walk at least 14m
(3)Stable medical condition
Key exclusion criteria (1) Severe cardiopulmonary disease
(2) Severe sensory disturbance or severe ataxia or severe higher brain dysfunction
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Sota
Middle name
Last name Araki s
Organization Acras Central Hospital
Division name Department of rehabilitation
Zip code 890-0031
Address 1 -121-5 Takeoka,Kagoshima,Japan
TEL 099-203-0100
Email arakisota@gmail.com

Public contact
Name of contact person
1st name sota
Middle name
Last name Araki
Organization Acras Central Hospital
Division name Department of rehabilitation
Zip code 890-0031
Address 1 -121-5 Takeoka,Kagoshima,Japan
TEL 099-203-0100
Homepage URL
Email arakisota@gmail.com

Sponsor
Institute Acras Central Hospital
Institute
Department

Funding Source
Organization None
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 Acras Central Hospital
Address 1 -121-5 Takeoka,Kagoshima,Japan
Tel 099-203-0100
Email acras_hp@yahoo.co.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
2018 Year 10 Month 20 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
2018 Year 10 Month 03 Day
Date of IRB
2018 Year 07 Month 04 Day
Anticipated trial start date
2018 Year 10 Month 03 Day
Last follow-up date
2023 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 19 Day
Last modified on
2019 Year 10 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039417

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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