UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023469
Receipt number R000022507
Scientific Title Usefulness of wearable robot "Bionic Leg" in rehabilitation
Date of disclosure of the study information 2016/08/03
Last modified on 2019/08/06 09:21:23

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Basic information

Public title

Usefulness of wearable robot "Bionic Leg" in rehabilitation

Acronym

Usefulness of"Bionic Leg"

Scientific Title

Usefulness of wearable robot "Bionic Leg" in rehabilitation

Scientific Title:Acronym

Usefulness of"Bionic Leg"

Region

Japan


Condition

Condition

disuse syndrome

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We investigate whether "Bionic leg" is useful or not in order to prevent deconditioning or recover from disuse syndrome.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Ratio of improvement of patients who can stand up from bed owing to usage of "Bionic Leg"

Key secondary outcomes

Improvement of FIM score until discharge from the hospital


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

Maneuver

Interventions/Control_1

Patients with difficulty of standing up are performed rehabilitation using Vionic Leg.

Interventions/Control_2

Patients with difficulty of standing up are performed ordinary rehabilitation.

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients performed rehabilitation at National Defense Medical College Hospital
Weight 50 - 135 kg
possible of sitting
unable to stand up
informed consent is obtained

Key exclusion criteria

impossible of sitting
dementia unable to understand instructions of therapists

Target sample size

240


Research contact person

Name of lead principal investigator

1st name Tatsuo
Middle name
Last name Kobayashi

Organization

National Defense Medical College

Division name

Rehabilitation

Zip code

359-8513

Address

3-2, Namiki, Tokorozawa

TEL

04-2995-1511

Email

tkobayas@ndmc.ac.jp


Public contact

Name of contact person

1st name Tatsuo
Middle name
Last name Tatsuo Kobayashi

Organization

National Defense Medical College

Division name

Rehabilitation

Zip code

359-8513

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

National Defense Medical College

Address

3-2, Namiki, Tokorozawa, Saitama

Tel

0429951511

Email

tkobayas@ndmc.ac.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

防衛医科大学校


Other administrative information

Date of disclosure of the study information

2016 Year 08 Month 03 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

0

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

Terminated

Date of protocol fixation

2016 Year 08 Month 03 Day

Date of IRB

2016 Year 05 Month 11 Day

Anticipated trial start date

2016 Year 08 Month 03 Day

Last follow-up date

2019 Year 08 Month 05 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 08 Month 03 Day

Last modified on

2019 Year 08 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022507


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name