UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033556
Receipt number R000038265
Scientific Title Verification of effectiveness using gait exercise assist robot in patients with hemiplegia
Date of disclosure of the study information 2018/07/31
Last modified on 2022/11/01 15:42:36

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Basic information

Public title

Verification of effectiveness using gait exercise assist robot in patients with hemiplegia

Acronym

Study on gait exercise assist robot in patients with hemiplegia

Scientific Title

Verification of effectiveness using gait exercise assist robot in patients with hemiplegia

Scientific Title:Acronym

Study on gait exercise assist robot in patients with hemiplegia

Region

Japan


Condition

Condition

stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to verify the effectiveness with gait exercise assist robot in severe hemiplegic patients who need knee-ankle-foot orthosis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

improvement in efficiency of FIM-walk

Key secondary outcomes

Stroke Impairment Assessment Set (SIAS),
gait velocity


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The interventions for the subjects are the training with gait exercise assist robot (Wel-walk).
The frequency of the interventions for inpatients is 40 minutes a day and five times a week. The maximum period is eight weeks.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Inpatients with hemiplegia in a rehabilitation ward
The general condition is stable
Standing and walking training is permitted by the doctor.
Patients require the knee-ankle-foot orthosis to stand and walk by the judgement ofthe rehabilitation doctor.
Informed-consent has been obtained

Key exclusion criteria

High-blood pressure (systolic blood pressure >= 180 mmHg or diastolic blood pressure >= 120 mmHg or resting heart rate >= 120/min)
Restricted exercise due to heart function or respiratory function disorder
Hearing or visual impairment
Dementia or severe higher brain dysfunction

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Izumi
Middle name
Last name Kondo

Organization

National Center for Geriatrics and Gerontology

Division name

Department of Rehabilitation medicine

Zip code

474-8511

Address

7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan

TEL

0562-46-2311

Email

ik7710@ncgg.go.jp


Public contact

Name of contact person

1st name Izumi
Middle name
Last name Kondo

Organization

National Center for Geriatrics and Gerontology

Division name

Department of Rehabilitation medicine

Zip code

474-8511

Address

7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan

TEL

0562-46-2311

Homepage URL


Email

ik7710@ncgg.go.jp


Sponsor or person

Institute

National Center for Geriatrics and Gerontology

Institute

Department

Personal name



Funding Source

Organization

National Center for Geriatrics and Gerontology

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

National Center for Geriatrics and Gerontology

Address

7-430, Morioka-cho, Obu-shi, Aichi, 474-8511, Japan

Tel

0562-46-2311

Email

ik7710@ncgg.go.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



Other administrative information

Date of disclosure of the study information

2018 Year 07 Month 31 Day


Related information

URL releasing protocol

https://www.jstage.jst.go.jp/article/jpts/34/11/34_2022-064/_article/-char/en

Publication of results

Unpublished


Result

URL related to results and publications

https://www.jstage.jst.go.jp/article/jpts/34/11/34_2022-064/_article/-char/en

Number of participants that the trial has enrolled

16

Results

Nine patients were able to walk 10 m at supervision or independent level.
Seven patients required assistance.

Results date posted

2022 Year 11 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

16 stroke patients as the participants of the study
age 67 years(SD:13)
female n=9

Participant flow

Written informed consent was obtained from each participant or from the participant's family prior to participation.

Adverse events

no

Outcome measures

10m walking assistance
SIAS(Stroke Impairment Assessment Set)

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2015 Year 09 Month 01 Day

Date of IRB

2015 Year 10 Month 01 Day

Anticipated trial start date

2015 Year 09 Month 01 Day

Last follow-up date

2021 Year 03 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

2018 Year 07 Month 30 Day

Last modified on

2022 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038265


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name