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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034581
Receipt No. R000039219
Scientific Title Clinical study to verify the effectiveness of a knee ankle foot orthosis with MR fluid in the knee joint
Date of disclosure of the study information 2018/10/20
Last modified on 2019/04/22

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Basic information
Public title Clinical study to verify the effectiveness of a knee ankle foot orthosis with MR fluid in the knee joint
Acronym Effectiveness of MR-KAFO
Scientific Title Clinical study to verify the effectiveness of a knee ankle foot orthosis with MR fluid in the knee joint
Scientific Title:Acronym Effectiveness of MR-KAFO
Region
Japan

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

Objectives
Narrative objectives1 The purpose of this research is to verify whether the knee ankle foot orthosis (KAFO) with (magneto-rheological (MR) fluid in the knee joint (MR-KAFO) would be more useful than the conventional KAFO.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Evaluation items are neurological findings, severity of paralysis (Brunnstrome stage, SIAS), measurement of range of motion in the joints, manual muscle testing in the sound side, activities of daily living (FIM), walking evaluation. In addition, we listen to opinions on whether physical therapists are easy to use in their gait training.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 The MR-KAFO is used for gait training of patients with severe hemiplegia due to acute onset stroke.
Interventions/Control_2 Medical histories are investigated for patients who have performed gait training using a conventional KAFO.
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
41 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria 1) Patients with acute first stroke, who receive rehabilitation training from the earliest onset
2) Patients with severe hemiplegia, who can not walk with the AFO
Key exclusion criteria 1) Patients who have no adaptation for gait training due to prolonged consciousness disturbance
2) Patients who do not understand the contents of gait training at all or refuse to train, because of severe aphasia or higher brain dysfunction.
3) Patients who are strongly tired and can not perform the gait training, because of complications such as heart diseases and kidney diseases.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kozo
Middle name
Last name Hanayama
Organization Kawasaki Medical School
Division name Rehabilitation Medicine
Zip code 701-0192
Address 577 Matsushima, Kurashiki-City, Okayama
TEL 0864621111
Email hanayama@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name Akio
Middle name
Last name Tsubahara
Organization Kawasaki University of Medical Welfare
Division name Rehabilitation
Zip code 701-0193
Address 288 Matsushima, Kurashiki-City, Okayama
TEL 0864621111
Homepage URL
Email atsuba@mw.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Kawasaki University of Medical Welfare
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kawasaki Medical School
Address 577 Matsushima, Kurashiki-City, Okayama
Tel 086-462-1111
Email kenkyuhou@med.kawasaki-m.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 川崎医科大学附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 20 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
2018 Year 10 Month 20 Day
Date of IRB
2018 Year 12 Month 05 Day
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2020 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
2018 Year 10 Month 20 Day
Last modified on
2019 Year 04 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039219

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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