UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021807
Receipt number R000025147
Scientific Title Development and assessment of elastic foot-up orthosis for patients with mild hemiparesis (equinovarus foot) or drop foot.
Date of disclosure of the study information 2016/04/07
Last modified on 2017/04/07 18:19:48

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Basic information

Public title

Development and assessment of elastic foot-up orthosis for patients with mild hemiparesis (equinovarus foot) or drop foot.

Acronym

Study of elastic foot-up orthosis for equinovarus foot or drop foot

Scientific Title

Development and assessment of elastic foot-up orthosis for patients with mild hemiparesis (equinovarus foot) or drop foot.

Scientific Title:Acronym

Study of elastic foot-up orthosis for equinovarus foot or drop foot

Region

Japan


Condition

Condition

Mild hemiplegia
Drop foot

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Development of elastic foot-up orthosis for equinovarus or drop foot

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The changes of temporal gait parameters by using the experimental elastic foot-up orthosis

Key secondary outcomes

Questionnaire about a feeling of wearing the experimental elastic foot-up orthosis


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


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

Walking with a elastic foot-up orthosis

Interventions/Control_2

Walking with a plastic ankle foot orthosis

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

Mild hemiparetic patients (Brunnstrom stage 4,5)
Drop foot

Key exclusion criteria

Persons who have diseases causing lower limb pain such as rheumatoid arthritis
Persons who have some kind of disorder on cognitive, psychiatric, and psychological function

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kimitaka Hase

Organization

Kansai Medical University Hospital

Division name

Department of Rehabilitation Medicine

Zip code


Address

2-3-1 Shinmachi, Hirakata, Osaka

TEL

+81-72-804-2780

Email

hasekim@hirakata.kmu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kimitaka Hase

Organization

Kansai Medical University Hospital

Division name

Department of Rehabilitation Medicine

Zip code


Address

2-3-1 Shinmachi, Hirakata, Osaka

TEL

+81-72-804-2780

Homepage URL


Email

hasekim@hirakata.kmu.ac.jp


Sponsor or person

Institute

Kansai Medical University

Institute

Department

Personal name



Funding Source

Organization

self-sustaining

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Ohi manufacturing Co.,Ltd

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

2016 Year 04 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


Results

The elastic foot-up orthosis for equinovarus or drop foot in the patients with less severe hemiparesis was effective in improving gait performance. The subjective scores on the feeling of wearing the elastic foot-up orthosis were better than them of wearing a shoehorn AFO.

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

2016 Year 04 Month 07 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 20 Day

Last follow-up date

2016 Year 12 Month 13 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2016 Year 12 Month 13 Day


Other

Other related information



Management information

Registered date

2016 Year 04 Month 06 Day

Last modified on

2017 Year 04 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025147


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name