UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020569
Receipt number 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 22:42:32

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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 or person

Institute

Kagoshima University

Institute

Department

Personal name



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

Value
https://center6.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