UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022335
Receipt number R000025743
Scientific Title Effects of Rehabilitation using the Hybrid Assistive Limb in Stroke Patients
Date of disclosure of the study information 2016/05/17
Last modified on 2017/11/20 13:37:26

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Basic information

Public title

Effects of Rehabilitation using the Hybrid Assistive Limb in Stroke Patients

Acronym

Effects of Rehabilitation using the HAL in Stroke Patients

Scientific Title

Effects of Rehabilitation using the Hybrid Assistive Limb in Stroke Patients

Scientific Title:Acronym

Effects of Rehabilitation using the HAL in Stroke Patients

Region

Japan


Condition

Condition

Post-stroke patients

Classification by specialty

Neurology Neurosurgery Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the efficacy of gait training using a single-leg version of the Hybrid Assistive Limb (HAL) on the paretic side with conventional gait training in individuals with stroke.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Functional Ambulation Category.

Outcome measures are evaluate prior to training, after 12 sessions (4 weeks), and at 8 and 12 weeks after intervention initiation.

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

HAL group perform gait training using the HAL 3 times a week with a total of 12 HAL training sessions (4 weeks).

Interventions/Control_2

Conventional group perform conventional gait training (CGT) 3 times a week with a total of 12 CGT training sessions (4 weeks).

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

Hemiparesis resulting from unilateral ischemic or hemorrhagic stroke
Time since stroke onset of within six months

Key exclusion criteria

1) Patients did not consent in this study.
2) Patients not ambulating prior to stroke.
3) Patients with a score of 4 or 5 on the Functional Ambulation Category.
4) Patients with severe disturbance of consciousness (II or III on the Japan Coma Scale).
5) Patients with severe cardiac disease (New York Heart Association Classification of III or IV) .
6) Patients with size limitations for the robotic orthosis.
7) Persons on whom it was impossible to paste an electrode because of skin disease.
8) Persons who had an implanted pacemaker.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hisako Yanagi

Organization

University of Tsukuba

Division name

Faculty of Medicine

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki 305-8577, Japan.

TEL

029-853-3496

Email

hyanagi@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiroki Watanabe

Organization

University of Tsukuba

Division name

Faculty of Medicine

Zip code


Address

1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575, Japan.

TEL

029-853-1131

Homepage URL


Email

watanabe.hiroki.gb@u.tsukuba.ac.jp


Sponsor or person

Institute

University of Tsukuba

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


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

筑波記念病院(茨城県)


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 17 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

Main results already published

Date of protocol fixation

2013 Year 02 Month 06 Day

Date of IRB


Anticipated trial start date

2013 Year 02 Month 06 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 05 Month 17 Day

Last modified on

2017 Year 11 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025743


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name