UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019559
Receipt number R000022508
Scientific Title Research for effectiveness on walking ability of patients with impairment of low extremities by robot-suit "HAL"
Date of disclosure of the study information 2015/10/29
Last modified on 2017/05/01 15:45:01

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Basic information

Public title

Research for effectiveness on walking ability of patients with impairment of low extremities by robot-suit "HAL"

Acronym

effectiveness on walking ability by robot-suit "HAL"

Scientific Title

Research for effectiveness on walking ability of patients with impairment of low extremities by robot-suit "HAL"

Scientific Title:Acronym

effectiveness on walking ability by robot-suit "HAL"

Region

Japan


Condition

Condition

impairment of low extremities

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate whether stand up and walk ability of patients with impairment of low extremities improve or not by robot-suit "HAL".

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Two times a week rehabilitation were performed for 5 weeks.
We evaluate stand up and walk ability at the end of 5 weeks rehabilitation.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

We investigate whether rehabilitation using robot suit HAL(Cyberdyne) for patients with chronic impairment of low extremities results in their functional improvement or not.
Two times (30-40 mins) a week rehabilitation were performed for 5 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

20 years-old <=

Age-upper limit

100 years-old >=

Gender

Male and Female

Key inclusion criteria

chronic impairment of low extremities
possible to stand up with assistance
possible to sit
weight under 80kg
height 145cm - 185cm
obtained informed consent for the study

Key exclusion criteria

severe joint disorders
dementia unable to obey instructions from therapists

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tatsuo Kobayashi

Organization

National Defense Medical College

Division name

Rehabilitation

Zip code


Address

3-2, Namiki, Tokorozawa

TEL

04-2995-1511

Email

tkobayas@ndmc.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tatsuo Kobayashi

Organization

National Defense Medical College

Division name

Rehabilitation

Zip code


Address

3-2, Namiki, Tokorozawa

TEL

04-2995-1511

Homepage URL


Email

tkobayas@ndmc.ac.jp


Sponsor or person

Institute

National Defense Medical College

Institute

Department

Personal name



Funding Source

Organization

National Defense Medical College

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

防衛医科大学校


Other administrative information

Date of disclosure of the study information

2015 Year 10 Month 29 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results

It took several time exercises to accustomed to the use of "HAL".
In possible gait group patients with abnormal walking patterns got improvement, but patients with weak muscle strength owing to their disease could not get improvement.
In impossible gait group some patients could not continue rehabilitation exercise owing to their low stamina. The patient who could walk using "HAL" need to use bilateral side canes.

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

2011 Year 10 Month 31 Day

Date of IRB


Anticipated trial start date

2011 Year 12 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2016 Year 11 Month 01 Day


Other

Other related information



Management information

Registered date

2015 Year 10 Month 29 Day

Last modified on

2017 Year 05 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022508


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name