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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035275
Receipt No. R000040189
Scientific Title Adaptation of Ankle foot orthosis to gait disturbance in post-stroke
Date of disclosure of the study information 2018/12/26
Last modified on 2018/12/17

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Basic information
Public title Adaptation of Ankle foot orthosis to gait disturbance in post-stroke
Acronym Adaptation of Ankle foot orthosis to gait disturbance in post-stroke
Scientific Title Adaptation of Ankle foot orthosis to gait disturbance in post-stroke
Scientific Title:Acronym Adaptation of Ankle foot orthosis to gait disturbance in post-stroke
Region
Japan

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

Objectives
Narrative objectives1 To investigate the adaptation of Ankle foot orthosis to gait disturbance in post-stroke cases
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Spatiotemporal parameters during gait in different conditions of Ankle foot orthosis(gait speed, step length, duration of single leg stance and double support)
Key secondary outcomes Muscle activities of lower limbs during gait in different conditions of Ankle foot orthosis
Gait parameters without Ankle foot orthosis

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Ankle foot orthosis(ankle joint plantar-dorsiflexion stop)
Interventions/Control_2 Ankle foot orthosis(ankle joint dorsiflexion free and plantar flexion stop)
Interventions/Control_3 Ankle foot orthosis(ankle joint dorsiflexion free and plantarflexion oil damper)
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. can 10 meters walk without assist
2.MMSE 24 scores or more
Key exclusion criteria 1. Other neurological disorders and orthopedic disease
2.lower limbs pain
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Naruhito Hasui
Organization Kio University
Division name Department of Neurorehabilitation, Graduate School of Health Science
Zip code
Address 4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL +81-745-54-1601
Email reha.pt1016@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Naruhito Hasui
Organization Kio University
Division name Department of Neurorehabilitation, Graduate School of Health Science
Zip code
Address 4-2-2 umami-naka koryo-cho, kitakatsuragi-gun, Nara, 635-0832 JAPAN
TEL +81-745-54-1601
Homepage URL
Email reha.pt1016@gmail.com

Sponsor
Institute Kio University
Institute
Department

Funding Source
Organization No
Organization
Division
Category of Funding Organization Other
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 宝塚リハビリテーション病院(兵庫県)

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 26 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 No longer recruiting
Date of protocol fixation
2017 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 17 Day
Last modified on
2018 Year 12 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040189

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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