UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development and assessment of elastic foot-up orthosis for patients with mild hemiparesis (equinovarus foot) or drop foot.
Title of the study (Brief title)	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	Kimitaka Hase
Organization	Kansai Medical University Hospital
Division name	Department of Rehabilitation Medicine
Address	2-3-1 Shinmachi, Hirakata, Osaka
TEL	+81-72-804-2780
Email	hasekim@hirakata.kmu.ac.jp

Public contact
Name of contact person	Kimitaka Hase
Organization	Kansai Medical University Hospital
Division name	Department of Rehabilitation Medicine
Address	2-3-1 Shinmachi, Hirakata, Osaka
TEL	+81-72-804-2780
Homepage URL
Email	hasekim@hirakata.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 07 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
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.
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025147