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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040226
Receipt No. 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 2020/04/23

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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
Email 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
Email yusuke.sekiguchi.b2@tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email 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 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
2020 Year 04 Month 24 Day
Date of IRB
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
2020 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045888

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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