UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031194
Receipt number R000035611
Scientific Title The effects of gait training using an ankle-foot orthosis with a modular exoskeletal robot actuated by pneumatic artificial muscles
Date of disclosure of the study information 2018/02/07
Last modified on 2019/08/10 20:00:56

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Basic information

Public title

The effects of gait training using an ankle-foot orthosis with a modular exoskeletal robot actuated by pneumatic artificial muscles

Acronym

The effects of gait training using a powered ankle-foot orthosis

Scientific Title

The effects of gait training using an ankle-foot orthosis with a modular exoskeletal robot actuated by pneumatic artificial muscles

Scientific Title:Acronym

The effects of gait training using a powered ankle-foot orthosis

Region

Japan


Condition

Condition

Stroke patients with hemiparesis

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The treatment effects of hemiparetic gait training using an ankle-foot orthosis with a modular exoskeletal robot

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The changes of ankle movements during hemiparetic gait just after and after 1 month of treatments

Key secondary outcomes

The kinematic changes during hemiparetic gait
The changes of EMG patterns during hemiparetic gait
Muscular powers during stepping
Gait speeds
Gait Assessment and Intervention Tool scores


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Ankle robot gait trainings (15 sessions, 30 minutes/session)

Interventions/Control_2

Conventional gait training (15 sessions, 30 minutes/session)

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Passive ankle range of motion of 40 degrees or more
The ankle proprioceptive ability of about 10 degrees
Independent indoor walking with an ankle-foot orthosis

Key exclusion criteria

Sensory loss of paretic foot
Neuromuscular or joint diseases affecting gait
Severe aphasia or cognitive disorders

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Kimitaka
Middle name
Last name Hase

Organization

Kansai Medical University

Division name

Physical Medicine of Rehabilitation

Zip code

573-1191

Address

3-1 Shinmachi 2 Chome, Hirakata City, Osaka

TEL

+81-72-804-0101

Email

hasekim@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name Kimitaka
Middle name
Last name Hase

Organization

Kansai Medical University

Division name

Physical Medicine of Rehabilitation

Zip code

573-1191

Address

3-1 Shinmachi 2 Chome, Hirakata City, Osaka

TEL

+81-72-804-0101

Homepage URL


Email

hasekim@hirakata.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical University

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics committees of the Kansai Medical University hospital

Address

2-3-1, Shinmachi, Hirakata, Osaka

Tel

+81-72-804-0101

Email

kmu@esct.bvits.com


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 02 Month 07 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

19

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

Completed

Date of protocol fixation

2017 Year 12 Month 08 Day

Date of IRB

2018 Year 02 Month 20 Day

Anticipated trial start date

2018 Year 03 Month 19 Day

Last follow-up date

2019 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 02 Month 07 Day

Last modified on

2019 Year 08 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035611


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name