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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028126
Receipt No. R000032197
Scientific Title Effect of dorsiflexion resistance of an ankle foot orthosis on the gait of stroke patients in recovery phase
Date of disclosure of the study information 2017/08/01
Last modified on 2018/04/04

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Basic information
Public title Effect of dorsiflexion resistance of an ankle foot orthosis on the gait of stroke patients in recovery phase
Acronym Effect of dorsiflexion resistance of an ankle foot orthosis on the gait of stroke patients in recovery phase
Scientific Title Effect of dorsiflexion resistance of an ankle foot orthosis on the gait of stroke patients in recovery phase
Scientific Title:Acronym Effect of dorsiflexion resistance of an ankle foot orthosis on the gait of stroke patients in recovery phase
Region
Japan

Condition
Condition Cerebrovascular disease
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To know the effect of dorsiflexion resistance of an AFO on the gait of stroke patients in recovery phase
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Gait speed before and after 2week gait training using AFOs
Key secondary outcomes Kinematic and kinetic parameters in gait before and after 2week gait training using AFOs

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Plastic AFO without mechanical ankle joint
Gait training using an AFO by physio-therapists onece a day for 1 hour for 2 weeks
Interventions/Control_2 Plastic AFO with mechanical ankle joint with an oil damper
Gait training using an AFO by physio-therapists onece a day for 1 hour for 2 weeks
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
40 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria Stroke patients
Less than 6 months since onset
Taking rehabilitation program at a hospital
Having gait training by physio therapists using AFOs

Key exclusion criteria Difficulty to understand oral instruction
Expected to disuse of an AFO in 2 weeks
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumiko Yamamoto
Organization International University of Health & Welfare
Division name Graduate school
Zip code
Address 1-3-3, MinamiAoyama, Minato-ku, Tokyo, Japan
TEL 03-6406-8632
Email sumiko-y@iuhw.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Sumiko Yamamoto
Organization International University of Health & Welfare
Division name Graduate school
Zip code
Address 1-3-3, MinamiAoyama, Minato-ku, Tokyo, Japan
TEL 03-6406-8632
Homepage URL
Email sumiko-y@iuhw.ac.jp

Sponsor
Institute International University of Health & Welfare
Institute
Department

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 Nakaizu Rehabilitation Center
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 農協共済中伊豆リハビリテーションセンター(静岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 25 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 05 Month 31 Day
Date trial data considered complete
2019 Year 06 Month 30 Day
Date analysis concluded
2020 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 07 Day
Last modified on
2018 Year 04 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032197

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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