UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of an ankle-foot orthosis with dorsiflexion resistance on stance phase in hemiplegic gait
Title of the study (Brief title)	The effect of an ankle-foot orthosis with dorsiflexion resistance on stance phase in hemiplegic gait
Region	Japan

Condition
Condition	stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of an ankle-foot orthosis with dorsiflexion resistance on stance phase in hemiplegic gait
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Electromyography
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	ankle-foot orthosis with dorsiflexion resistance
Interventions/Control_2
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	ability to walk independently
Key exclusion criteria	1.walking with assistance 2.gait symptoms from parkinsonism or ataxia 3.gait symptoms due to orthopedic disease 4.limitation of activity due to heart disease 5.difficulty understanding experimental tasks due to cognitive problems 6.contracture inhibiting dorsiflexion beyond neutral
Target sample size	30

Research contact person
Name of lead principal investigator	Yutaka Okada
Organization	Kawasaki Junior College of Rehabilitation
Division name	Division of Physical Therapy
Address	672, Matsushima, Kurashiki Okayama
TEL	086-464-1179
Email	okayu@med.kawasaki-m.ac.jp

Public contact
Name of contact person	Yutaka Okada
Organization	kawasaki Junior College of Rehabilitation
Division name	Division of Physical Therapy
Address	672, Matsushima, Kurashiki Okayama
TEL	086-464-1179
Homepage URL
Email	okayu@med.kawasaki-m.ac.jp

Sponsor
Institute	Kawasaki Medical University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2012 Year 03 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 03 Month 26 Day
Anticipated trial start date	2012 Year 04 Month 01 Day
Last follow-up date	2017 Year 04 Month 21 Day
Date of closure to data entry	2019 Year 02 Month 19 Day
Date trial data considered complete	2019 Year 02 Month 19 Day
Date analysis concluded	2019 Year 02 Month 19 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.jstage.jst.go.jp/article/jspo/31/1/31_52/_article/-char/ja/
Results
Other related information

Management information
Registered date	2012 Year 03 Month 01 Day
Last modified on	2019 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008742