UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000018097
Receipt number R000020945
Scientific Title The effect of long term intervention using orthosis transforming sensory modality on gait in patiants with hemiparesis
Date of disclosure of the study information 2015/09/01
Last modified on 2021/10/02 12:28:10

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Basic information

Public title

The effect of long term intervention using orthosis transforming sensory modality on gait in patiants with hemiparesis

Acronym

The effect of long term intervention using orthosis transforming sensory modality on gait in patiants with hemiparesis

Scientific Title

The effect of long term intervention using orthosis transforming sensory modality on gait in patiants with hemiparesis

Scientific Title:Acronym

The effect of long term intervention using orthosis transforming sensory modality on gait in patiants with hemiparesis

Region

Japan


Condition

Condition

patients with hemiparesis due to brain tumor or stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to evaluate utility of long term intervention using the orthosis transforming sensory modality in gait with hemiparesis.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II,III


Assessment

Primary outcomes

gait speed, stride length, gait cycle time

Key secondary outcomes

kinematic data and kinetic data during gait


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Placebo

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

The subjects wear the orthosis transforming sensory modality and received 30 minutes of locomotion training on a treadmill.The orthosis makes sound when load at the heel or the distal condyle of a fifth metatarsal bone on the paretic side in stance phase during gait is input.

Interventions/Control_2

The subjects do not wear the orthosis transforming sensory modality and received 30 minutes of locomotion training on a treadmill.

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

1) unilateral cerebral lesions due to stroke or brain tumor confirmed by computed tomography or magnetic resonance imaging
2) the ability to follow verbal commands.
3) the first stroke over six monthes
4) the ability to walk for 30 minutes in which rest is taken

Key exclusion criteria

1)a history of orthopedic problems
2)diabetic peripheral neuropathy
3)brainstem or cerebellar lesions
4)unilateral spatial neglect

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shin-Ichi Izumi

Organization

Tohoku University

Division name

Graduate school of Biomedical Engineering

Zip code


Address

2-1 Seiryo-cho, Aoba-ku, Sendai, Japan

TEL

022-717-7338

Email

izumis@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yusuke Sekiguchi

Organization

Tohoku University

Division name

Department of Rehabilitation

Zip code


Address

1-1 Seiryo-cho, Aoba-ku, Sendai, Japan

TEL

022-717-7677

Homepage URL


Email

yusuke5547@yahoo.co.jp


Sponsor or person

Institute

Department of Physical Medicine and Rehabilitation,Tohoku University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


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



Other administrative information

Date of disclosure of the study information

2015 Year 09 Month 01 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


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

2015 Year 08 Month 15 Day

Date of IRB

2015 Year 10 Month 06 Day

Anticipated trial start date

2015 Year 10 Month 06 Day

Last follow-up date

2019 Year 08 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 06 Month 26 Day

Last modified on

2021 Year 10 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020945


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name