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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007422
Receipt No. R000008742
Scientific Title The effect of an ankle-foot orthosis with dorsiflexion resistance on stance phase in hemiplegic gait
Date of disclosure of the study information 2012/03/02
Last modified on 2019/02/19

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Basic information
Public title The effect of an ankle-foot orthosis with dorsiflexion resistance on stance phase in hemiplegic gait
Acronym The effect of an ankle-foot orthosis with dorsiflexion resistance on stance phase in hemiplegic gait
Scientific Title The effect of an ankle-foot orthosis with dorsiflexion resistance on stance phase in hemiplegic gait
Scientific Title:Acronym The effect of an ankle-foot orthosis with dorsiflexion resistance on stance phase in hemiplegic gait
Region
Japan

Condition
Condition stroke
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of an ankle-foot orthosis with dorsiflexion resistance on stance phase in hemiplegic gait
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Electromyography
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 ankle-foot orthosis with dorsiflexion resistance
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

Not applicable
Gender Male and Female
Key inclusion criteria ability to walk independently
Key exclusion criteria 1.walking with assistance
2.gait symptoms from parkinsonism or ataxia
3.gait symptoms due to orthopedic disease
4.limitation of activity due to heart disease
5.difficulty understanding experimental tasks due to cognitive problems
6.contracture inhibiting dorsiflexion beyond neutral
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Okada
Organization Kawasaki Junior College of Rehabilitation
Division name Division of Physical Therapy
Zip code
Address 672, Matsushima, Kurashiki Okayama
TEL 086-464-1179
Email okayu@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Okada
Organization kawasaki Junior College of Rehabilitation
Division name Division of Physical Therapy
Zip code
Address 672, Matsushima, Kurashiki Okayama
TEL 086-464-1179
Homepage URL
Email okayu@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical University
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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
2012 Year 03 Month 02 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.jstage.jst.go.jp/article/jspo/31/1/31_52/_article/-char/ja/
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 Completed
Date of protocol fixation
2012 Year 03 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2017 Year 04 Month 21 Day
Date of closure to data entry
2019 Year 02 Month 19 Day
Date trial data considered complete
2019 Year 02 Month 19 Day
Date analysis concluded
2019 Year 02 Month 19 Day

Other
Other related information

Management information
Registered date
2012 Year 03 Month 01 Day
Last modified on
2019 Year 02 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008742

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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