UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015039
Receipt number R000017498
Scientific Title Effects of patterned electrical stimulation on gait disturbance in patients with stroke.
Date of disclosure of the study information 2014/09/03
Last modified on 2018/10/14 20:26:57

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Basic information

Public title

Effects of patterned electrical stimulation on gait disturbance in patients with stroke.

Acronym

Effects of patterned electrical stimulation.

Scientific Title

Effects of patterned electrical stimulation on gait disturbance in patients with stroke.

Scientific Title:Acronym

Effects of patterned electrical stimulation.

Region

Japan


Condition

Condition

Post-stroke patients

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine effects of patterned electrical stimulation on gait disturbance in patients with stroke.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Electrophysiological assessment

Key secondary outcomes

Motor function of lower extremity, excitability of motor cortex assessed with transcranial magnetic stimulation(TMS), coherence analysis, gait analysis


Base

Study type

Interventional


Study design

Basic design

Cross-over

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

Maneuver

Interventions/Control_1

Combination of patterned electrical stimulation with voluntary contraction.

Interventions/Control_2

Combination of patterned electrical stimulation with foot orthosis.

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

Patients group:
Hemiparetic stroke patients with motor disability of lower extremity, over and equal to 120 days after stroke, no medical history of fracture and injury by fall within three months. FIM score of locomotion (ambulatory) is greater than 5 with/without T-cane and orthosis, FIM score of cognitive comprehension is greater than 4, SIAS position sense is greater than 0, SIAS visuospatial cognition is greater than 1, no clear cognitive dysfunction, agreement to participate in the research.

Healthy group:
A person shall not have medical history of musculoskeletal (lower extremity) and nervous system disease. Agreement to participate in the research.

Key exclusion criteria

Patients group:
A person shall not have epilepsy or its previous history, implanted electronic pacing or defibrillation devices.

Patients and healthy groups:
A person shall not have contraindications to gait:
serious cardiac disease: unstable angina, myocardial infarction shortly after symptom onset, decompensated congestive heart failure, acute cor pulmonale, uncontrolled arrhythmia, serious aortic stenosis, active myocarditis, endocarditis, etc.,
uncontrolled hypertension,
acute systemic disease or fever,
complication of recent pulmonary embolism, acute cor pulmonale or serious pulmonary hypertension, complication of serious liver or renal dysfunction, complication of serious orthopedic disease which bars gait capability,
complication of serious cognitive dysfunction, other metabolic abnormality (acute thyroiditis, etc.), pregnant.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Meigen Liu

Organization

Keio University School of Medicine

Division name

Department of Rehabilitation Medicine

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3833

Email

meigenliukeio@mac.com


Public contact

Name of contact person

1st name
Middle name
Last name Michiyuki Kawakami

Organization

Keio University School of Medicine

Division name

Department of Rehabilitation Medicine

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

03-5363-3833

Homepage URL


Email

michiyukikawakami@hotmail.com


Sponsor or person

Institute

Keio University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tokyo Bay Rehabilitation Hospital

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

2014 Year 09 Month 03 Day


Related information

URL releasing protocol


Publication of results

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

Completed

Date of protocol fixation

2014 Year 01 Month 22 Day

Date of IRB


Anticipated trial start date

2014 Year 04 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

2014 Year 09 Month 03 Day

Last modified on

2018 Year 10 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017498


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name