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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000041889
Receipt No. R000047672
Scientific Title Immediate effect of dorsiflexion angle of ankle foot orthosis on the spatiotemporal parameters of gait in chronic stroke individuals
Date of disclosure of the study information 2020/10/01
Last modified on 2020/11/05

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Basic information
Public title Immediate effect of dorsiflexion angle of ankle foot orthosis on the spatiotemporal parameters of gait in chronic stroke individuals
Acronym Immediate effect of dorsiflexion angle of ankle foot orthosis on the spatiotemporal parameters of gait in chronic stroke individuals
Scientific Title Immediate effect of dorsiflexion angle of ankle foot orthosis on the spatiotemporal parameters of gait in chronic stroke individuals
Scientific Title:Acronym Immediate effect of dorsiflexion angle of ankle foot orthosis on the spatiotemporal parameters of gait in chronic stroke individuals
Region
Japan

Condition
Condition Stroke individuals
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the immediate effects of dorsiflexion angle of ankle-foot orthosis on the spatiotemporal parameters of gait in chronic stroke individuals using a sheet-type foot pressure sensor
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Walking speed(m/s)
Key secondary outcomes Step length(m)
Stride length(m)
Step width(m)
Cadence(steps/min)
Percentage of the single support phase(%)
Percentage of the double support phase(%)

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Perform the 10-m walk test and walk on a sheet-type foot pressure sensor without AFO
Interventions/Control_2 Perform the 10-m walk test and walk on a sheet-type foot pressure sensor with APS-AFO(5 degree of dorsalflexion;fixed)
Interventions/Control_3 Perform the 10-m walk test and walk on a sheet-type foot pressure sensor with APS-AFO(-5 degree of plantarflexion,20 degree of dorsalflexion;restricted)
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)More than 6 months after diagnosis of hemiparesis caused by first ever cerebral hemorrhage or cerebral infarction.
2)Aged 20-79 years.
3)At least Functional Ambulation Category 4, with or without walking device.
4)Being able to follow simple verbal instructions.
5)Regularly use an ankle-foot orthosis.
Key exclusion criteria History of neuromuscular disease, spinal disease, or cerebral palsy
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Nobuyuki
Middle name
Last name Kawate
Organization Showa University
Division name Department of rehabilitation medicine
Zip code 227-8518
Address 2-1-1 Fujigaoka,Aoba-ku,Yokohama,Kanagawa
TEL 045-974-2221
Email kawate@med.showa-u.ac.jp

Public contact
Name of contact person
1st name Eri
Middle name
Last name Nojiri
Organization Showa University
Division name Department of rehabilitation medicine
Zip code 227-8518
Address 2-1-1 Fujigaoka,Aoba-ku,Yokohama,Kanagawa
TEL 045-974-2221
Homepage URL
Email n.e.ktan.1111@gmail.com

Sponsor
Institute Showa Univerisity
Institute
Department

Funding Source
Organization non
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Showa Univerisity Fujigaoka Hospital Institutional Review Board
Address 1-30 Fujigaoka,Aoba-ku,Yokohama,Kanagawa
Tel 045-974-6329
Email f-irb@cmed.showa-u.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

Other administrative information
Date of disclosure of the study information
2020 Year 10 Month 01 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 Open public recruiting
Date of protocol fixation
2020 Year 08 Month 27 Day
Date of IRB
2020 Year 09 Month 30 Day
Anticipated trial start date
2020 Year 10 Month 10 Day
Last follow-up date
2021 Year 03 Month 31 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 09 Month 24 Day
Last modified on
2020 Year 11 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047672

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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