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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025482
Receipt No. R000029327
Scientific Title The effects of foot drop stimulator controlled by a tilt sensor combined with integrated volitional control electrical stimulation on gait performance in stroke patients
Date of disclosure of the study information 2017/01/04
Last modified on 2018/07/08

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Basic information
Public title The effects of foot drop stimulator controlled by a tilt sensor combined with integrated volitional control electrical stimulation on gait performance in stroke patients
Acronym The effects of foot drop stimulator controlled combined with integrated volitional control electrical stimulation in stroke patients
Scientific Title The effects of foot drop stimulator controlled by a tilt sensor combined with integrated volitional control electrical stimulation on gait performance in stroke patients
Scientific Title:Acronym The effects of foot drop stimulator controlled combined with integrated volitional control electrical stimulation in stroke patients
Region
Japan

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

Objectives
Narrative objectives1 To investigate whether or not foot drop stimulator controlled combined with integrated volitional control electrical stimulation would improve gait performance of patients with post-stroke
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Root mean squares of trunk acceleration during walking
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 Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Foot drop stimulator controlled combined with integrated volitional control electrical stimulation in addition to usual rehabilitation program
Interventions/Control_2 Integrated volitional control electrical stimulation in addition to usual rehabilitation program
Interventions/Control_3 Usual rehabilitation program alone
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) First-time stroke with a duration of less than 6 months from the onset of stroke
3) The ability to walk without support for at least 30-meters
4) The score of SIAS foot-pat test is 1 or more.
5) 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 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsubasa Mitsutake
Organization Shiroishi Kyoritsu Hospital
Division name Department of Rehabilitation
Zip code
Address 1296 Fukuta, Shiroishi-cho, Kishima-gun, Saga
TEL 0952-84-6060
Email mitutuba1012@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tsubasa Mitsutake
Organization Shiroishi Kyoritsu Hospital
Division name Department of Rehabilitation
Zip code
Address 1296 Fukuta, Shiroishi-cho, Kishima-gun, Saga
TEL 0952-84-6060
Homepage URL
Email mitutuba1012@gmail.com

Sponsor
Institute Shiroishi Kyoritsu Hospital
Institute
Department

Funding Source
Organization nothing
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 白石共立病院(佐賀県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 04 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 Completed
Date of protocol fixation
2017 Year 01 Month 04 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 11 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 30 Day
Last modified on
2018 Year 07 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029327

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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