UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024152
Receipt No. R000027808
Scientific Title Validity and effect of lower extremity orthosis with simple sensor in patients with hemiparesis
Date of disclosure of the study information 2016/10/10
Last modified on 2016/09/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Preinitiation
Date of protocol fixation
2016 Year 10 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
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
2016 Year 09 Month 25 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.