UMIN-CTR Clinical Trial

Basic information
Public title	Validity and effect of lower extremity orthosis with simple sensor in patients with hemiparesis
Acronym	Validity and effect of lower extremity orthosis with simple sensor in patients with hemiparesis
Scientific Title	Validity and effect of lower extremity orthosis with simple sensor in patients with hemiparesis
Scientific Title:Acronym	Validity and effect of lower extremity orthosis with simple sensor in patients with hemiparesis
Region	Japan

Condition
Condition	healthy controls patients with hemiparesis due to stroke
Classification by specialty	Rehabilitation medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The objective is to examine the effect of the combination of hip orthosis and ankle orthosis, which we developed. The objective is to examine the validity of the kinetic and kinematic parameters which is measured by the newly developed sensor, using three dimentional motion analysis system.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	The comparison of the kinematic and kinetic parameters among the conditions.
Key secondary outcomes	The consistency of the data that are measured using three dimensional motion analysis system and that are measured using the newly developed sensor.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	The patients with hemiparesis due to stroke and healthy controls wearing hip and ankle orthosises walk along a 7m walkway under nine conditions of elastic dampars. The subjects walk along a 7m walkway at self-selected comfortable speed. The controls walk along a 7m walkway at slowly and fast speeds.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) The inclusion criteria for subjects with hemiparesis due to stroke were as follows: 1) unilateral cerebral lesions confirmed by computed tomography or magnetic resonance imaging; 2) the ability to walk at least 7 m without assistive devices; 3) the ability to follow verbal commands; 4) 20 years of age or more; and 5) performing rehabilitation at Tohoku university hospital. The inclusion criteria for controls included 2) and 3).
Key exclusion criteria	The subjects with hemiparesis and controls were excluded if they had the following: 1) diabetic peripheral neuropathy; 2) a history of orthopedic problems; 3) brainstem or cerebellar lesions; and 4) unilateral spactial neglect.The score of visuospatial perception in SIAS(stroke impairment assessmnet set) is less than 2. The exclusion criteria for controls were as follows: 1) a history of a disorder of the central nervous system and peripheral neuropathy and 2) a history of orthopedic problems.
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	Department of Physical Medicine and Rehabilitation
Zip code
Address	2-1 Seiryo-cho, Aoba-ku, Sendai
TEL	022-717-7677
Email	izumis@bme.tohoku.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yusuke Sekiguchi
Organization	Tohoku University Hospital
Division name	Department of Rehabilitation
Zip code
Address	1-1 Seiryo-cho, Aoba-ku, Sendai
TEL	022-717-7677
Homepage URL
Email	yusuke5547@yahoo.co.jp

Sponsor
Institute	Tohoku University
Institute
Department

Funding Source
Organization	The Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor	NEC Corporation
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	東北大学病院（宮城県）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 10 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	Main results already published
Date of protocol fixation	2016 Year 10 Month 10 Day
Date of IRB	2016 Year 10 Month 05 Day
Anticipated trial start date	2016 Year 11 Month 01 Day
Last follow-up date	2017 Year 11 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	2016 Year 09 Month 25 Day
Last modified on	2019 Year 10 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027808