UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024152 |
|---|---|
| Receipt number | 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 | 2019/10/25 20:40:07 |
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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
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
yusuke5547@yahoo.co.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027808
