UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017402 |
|---|---|
| Receipt number | R000020187 |
| Scientific Title | The effect of orthosis transforming sensory modality on gait in patiants with hemiparesis |
| Date of disclosure of the study information | 2015/05/03 |
| Last modified on | 2017/10/11 05:43:29 |
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Basic information
Public title
The effect of orthosis transforming sensory modality on gait in patiants with hemiparesis
Acronym
The examination of the effect of orthosis transforming sensory modality
Scientific Title
The effect of orthosis transforming sensory modality on gait in patiants with hemiparesis
Scientific Title:Acronym
The examination of the effect of orthosis transforming sensory modality
Region
| Japan |
Condition
Condition
patients with hemiparesis due to brain tumor or stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate utility of the orthosis transforming sensory modality in gait with hemiparesis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
gait speed, stride length, gait cycle time
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The subjects wear the orthosis transforming sensory modality. The orthosis makes sound when load at the heel on the paretic side in stance phase during gait is input.
Interventions/Control_2
The subjects wear the orthosis transforming sensory modality.The orthosis makes sound when load at the distal condyle of a fifth metatarsal bone on the paretic side in stance phase during gait is input.
Interventions/Control_3
The subjects wear the orthosis transforming sensory modality.The orthosis makes sound when load at the heel or the distal condyle of a fifth metatarsal bone on the paretic side in stance phase during gait is input.
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
1) unilateral cerebral lesions due to stroke or brain tumor confirmed by computed tomography or magnetic resonance imaging
2) the ability to walk at least 7 min without assistive devices
3) the ability to follow verbal commands.
Key exclusion criteria
1)a history of orthopedic problems
2)diabetic peripheral neuropathy
3)brainstem or cerebellar lesions
4)unilateral spatial neglect
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin-Ichi Izumi |
Organization
Tohoku University
Division name
Graduate school of Biomedical Engineering
Zip code
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Japan
TEL
022-717-7338
izumis@med.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, Japan
TEL
022-717-7677
Homepage URL
yusuke5547@yahoo.co.jp
Sponsor or person
Institute
Department of Physical Medicine and Rehabilitation,Tohoku University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
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
| 2015 | Year | 05 | Month | 03 | 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
| 2015 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | 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
| 2015 | Year | 05 | Month | 02 | Day |
Last modified on
| 2017 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020187
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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