UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033772
Receipt number R000038485
Scientific Title Investigation of intervention effect by the Integrated Volitional control Electrical Stimulation (IVES) to ankle dorsiflexor muscle of in in the convalescent stroke patients
Date of disclosure of the study information 2018/08/16
Last modified on 2019/09/17 16:32:41

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Basic information

Public title

Investigation of intervention effect by the Integrated Volitional control Electrical Stimulation (IVES) to ankle dorsiflexor muscle of in in the convalescent stroke patients

Acronym

Investigation of intervention effect by the Integrated Volitional control Electrical Stimulation (IVES) to ankle dorsiflexor muscle of in in the convalescent stroke patients

Scientific Title

Investigation of intervention effect by the Integrated Volitional control Electrical Stimulation (IVES) to ankle dorsiflexor muscle of in in the convalescent stroke patients

Scientific Title:Acronym

Investigation of intervention effect by the Integrated Volitional control Electrical Stimulation (IVES) to ankle dorsiflexor muscle of in in the convalescent stroke patients

Region

Japan


Condition

Condition

hemiplegic patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to Examine the effect of using IVES for hemiplegic patients with cerebrovascular disorder admitted to the rehabilitation ward of the Chiba Tokushukai Hospital

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Active-range of motion of ankle dorsiflex

Key secondary outcomes

Passive-range of motion of ankle dorsiflex
Muscular strength of ankle dorsiflexor muscle by the Hand-Held Daynamomater
6-Minute Walk Test (6MWT)
Fugl-Meyer Assessment
Brunnstrom recovery stage
IVES settings
Modified Ashworth Scale
Amount of assistance for walking
Maximum Gait speed
stride
Gait rate
Angle transition of ankle dorsiflexion during standing
Angle transition of ankle dorsiflexion during Gait


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

IVES

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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

hemiplegic patients
Level IV or higher on lower limb BRS
Patient who able to keep sitting or standing position by watching or self-reliance
Patients who can practice gait training assisted by occupational therapists or physical therapists

Key exclusion criteria

Severe aphasia , Severe dementia
Patients who cannot working IVES (Abandonment , Disapproval , Complete sensory paralysis)
Patients who are judged as difficult to gait by the doctor

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kikuko Ikeda

Organization

CHIBA TOKUSHUKAI HOSPITAL

Division name

Rehabilitation

Zip code


Address

2-11-1 Takanedai,Funabasi-shi,Chiba,Japan

TEL

047-466-7111

Email

xgmny681@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takahisa Kotaki

Organization

CHIBA TOKUSHUKAI HOSPITAL

Division name

Rehabilitation

Zip code


Address

2-11-1 Takanedai,Funabasi-shi,Chiba,Japan

TEL

047-466-7111

Homepage URL


Email

t.kotaki1012@gmail.com


Sponsor or person

Institute

CHIBA TOKUSHUKAI HOSPITAL

Institute

Department

Personal name



Funding Source

Organization

CHIBA TOKUSHUKAI HOSPITAL

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



Other administrative information

Date of disclosure of the study information

2018 Year 08 Month 16 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

2018 Year 03 Month 23 Day

Date of IRB

2018 Year 06 Month 15 Day

Anticipated trial start date

2018 Year 08 Month 01 Day

Last follow-up date

2018 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 08 Month 15 Day

Last modified on

2019 Year 09 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038485


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name