UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000036573
Receipt number R000041669
Scientific Title Validation of the effect of foot drop suppression equipment for stroke hemiplegia.
Date of disclosure of the study information 2019/04/22
Last modified on 2019/04/22 15:19:40

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Basic information

Public title

Validation of the effect of foot drop suppression equipment for stroke hemiplegia.

Acronym

Validation of the effect of foot drop suppression equipment for stroke hemiplegia.

Scientific Title

Validation of the effect of foot drop suppression equipment for stroke hemiplegia.

Scientific Title:Acronym

Validation of the effect of foot drop suppression equipment for stroke hemiplegia.

Region

Japan


Condition

Condition

Stroke hemiplegia

Classification by specialty

Rehabilitation medicine Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the rehabilitation effect of the device to prevent the foot drop of hemiplegic person

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1.Walking speed,stride length
2.Center of gravity
3.Floor reaction force
4.Joint angle

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is 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

To train by using the device three times a week.

Interventions/Control_2

To perform regular physical therapy training for a week.

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

50 years-old <=

Age-upper limit

75 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Things that can stand alone at Brunstrom Stage III (Recovery degree of motor paralysis) or higher
2.Have sufficient joint mobility (5 degrees dorsiflexion to 30 degrees dorsiflexion)
3. Those without sense of loss
4. Mini Mental State Examination (dementia diagnostic test) More than 23 points
5. Frontal Assessment Battery (frontal lobe disorder screening test) More than 12 points

Key exclusion criteria

1. Uncontrolled heart failure
2. Acute myocardial infarction
3. Active myocarditis or pericarditis
4. Unstable angina
5. Acute systemic embolism or pulmonary embolism
6. Acute infection
7. Thrombotic phlebitis
8. Ventricular tachycardia or intractable ventricular arrhythmia
9. Severe ventricular outflow tract obstruction
Ten. Uncontrolled arterial hypertension or pulmonary hypertension
11. At the same time, if you are in the target of another intervention study (verified with your physical therapist)
12. Excessive contracture

Target sample size

15


Research contact person

Name of lead principal investigator

1st name Iwata
Middle name
Last name Hiroyasu

Organization

Waseda University

Division name

Faculty science and engineering

Zip code

162-0042

Address

27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 P

TEL

03-3203-4427

Email

jubi@waseda.jp


Public contact

Name of contact person

1st name Iwata
Middle name
Last name Hiroyasu

Organization

Waseda University

Division name

Faculty science and engineering

Zip code

162-0042

Address

27 Waseda-cyo, Shinjuku-ku, Tokyo 162-0044, Japan Green Computing Systems Reserch Organization 603 P

TEL

03-3203-4427

Homepage URL


Email

jubi@waseda.jp


Sponsor or person

Institute

Waseda University

Institute

Department

Personal name



Funding Source

Organization

Waseda University

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor

Akiba Hospital

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Waseda University

Address

1-104, Totsukamachi, Shinjuku-ku, Tokyo Building 9, 2F

Tel

03-5272-1639

Email

rinri@list.waseda.jp


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

秋葉病院


Other administrative information

Date of disclosure of the study information

2019 Year 04 Month 22 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

Preinitiation

Date of protocol fixation

2019 Year 05 Month 01 Day

Date of IRB


Anticipated trial start date

2019 Year 05 Month 01 Day

Last follow-up date

2022 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 04 Month 22 Day

Last modified on

2019 Year 04 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041669


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name