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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020569
Receipt No. R000023749
Scientific Title The effect of functional electrical stimulation (WalkAide®)in the patients with brain injury: A pilot trial
Date of disclosure of the study information 2016/01/14
Last modified on 2016/01/30

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Basic information
Public title The effect of functional electrical stimulation (WalkAide®)in the patients with brain injury: A pilot trial
Acronym The effect of functional electrical stimulation
Scientific Title The effect of functional electrical stimulation (WalkAide®)in the patients with brain injury: A pilot trial
Scientific Title:Acronym The effect of functional electrical stimulation
Region
Japan

Condition
Condition Hemiplegic patients with brain injury
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of functional electrical stimulation for gait exercise
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 10m-walk test at baseline and after 8-week intervention
Key secondary outcomes Fugl-Meyer Assessment, Bnnstrom stage, dified Ashworth Scale, 6 minute walk test, Functional independence Measure: FIM, Frenchay Activities Index, Stroke impact 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 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Gait training with functionalelectrical stimulation (FES). Intervention with FES is scheduled 40min/day, five times a week, for 8 weeks.
Interventions/Control_2 Gait training with ankle-foot orthosis (AFO)
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
80 years-old >
Gender Male and Female
Key inclusion criteria hemiplegic patients with brain injury; stable condition; Brunnstrom recovery of lower limb >III; informed consent
Key exclusion criteria severe higher brain dysfunction; severe dementia; poor consciousness; previous gait disturbance; severe sensory disturbance; skin disease
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Matsumoto
Organization Kagoshima University
Division name Dept. of Rehabilitation
Zip code
Address 3930-7 Takachiho, Makizono-cho, Kirishima City
TEL 0995-78-2538
Email shushu@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuji Matsumoto
Organization Kagoshima University
Division name Dept. of Rehabilitation
Zip code
Address 3930-7 Takachiho, Makizono-cho, Kirishima City
TEL 0995-78-2538
Homepage URL
Email shushu@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University
Institute
Department

Funding Source
Organization Kagoshima University
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
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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2014 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 01 Month 14 Day
Last modified on
2016 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023749

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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