UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040226 |
|---|---|
| Receipt number | R000045888 |
| Scientific Title | The effects of ankle-foot orthosis with dorsiflexion resistance using spring-cam mechanism on gait in patients with hemiapresis |
| Date of disclosure of the study information | 2020/04/25 |
| Last modified on | 2023/04/26 16:31:47 |
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Basic information
Public title
The effects of a new orthosis that assists movement of the ankle during gait in patients with hemiparesis
Acronym
The effects of a new orthosis on gait in patients with hemiparesis
Scientific Title
The effects of ankle-foot orthosis with dorsiflexion resistance using spring-cam mechanism on gait in patients with hemiapresis
Scientific Title:Acronym
The effects of ankle-foot orthosis with dorsiflexion resistance on gait
Region
| Japan |
Condition
Condition
patients with hemiparesis due to brain damage
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine effects of ankle-foot orthosis with dorsiflexion resistance using spring-cam on gait in patients with hemiapresis due to brain damage
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
kinematic and kinetic parameters during gait
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
walking training with the ankle-foot orthosis with dorsiflexion resistance using spring-cam mechanism for three minutes
Interventions/Control_2
walking training with a traditional ankle-foot orthosis for three minutes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.patients with hemiparesis due to stroke or brain tumor
2.recovery or chronic phase
3.the ability to walk at least 7m without assistive devices
4.the ability to walk continuously for 3minutes
5.the ability to follow verbal commands
Key exclusion criteria
1.a history of orthopedic problems interfering with gait
2.brainstem or cerevellar lesions
3.abnormal mental status
4.higher brain dysfunction, which skewed measurements
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shin-ichi |
| Middle name | |
| Last name | Izumi |
Organization
Tohoku University Graduate School of Biomedical Engineering
Division name
Department of Physical Medicine and Rehabilitation
Zip code
9808575
Address
2-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL
0227177338
izumis@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sekiguchi |
Organization
Tohoku University Hospital
Division name
Department of Rehabilitation
Zip code
9808574
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
TEL
0227177677
Homepage URL
yusuke.sekiguchi.b2@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
SEKISUI CHEMICAL CO.,LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University Hospital Ethics Committee
Address
1-1 Seiryo-cho, Aoba-ku, Sendai, Miyagi, Japan
Tel
022-728-4105
ec@rinri.hosp.tohoku.ac.jp
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
| 2020 | Year | 04 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
17
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
| 2020 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 23 | Day |
Last modified on
| 2023 | Year | 04 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045888
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
