UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032094
Receipt No. R000036618
Scientific Title Clinical assessment of a knee ankle foot orthosis with braking knee joint
Date of disclosure of the study information 2018/06/01
Last modified on 2019/04/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Clinical assessment of a knee ankle foot orthosis with braking knee joint
Acronym Clinical assessment of a knee ankle foot orshosis with braking knee joint
Scientific Title Clinical assessment of a knee ankle foot orthosis with braking knee joint
Scientific Title:Acronym Clinical assessment of a knee ankle foot orshosis with braking knee joint
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 the Knee Ankle Foot Orthosis with mechanical knee joint containing electro attractive material 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 Trunk movement during gait before and after gait training using the orthosis
Key secondary outcomes Gait speed and kinematic and kinetic gait parameters before and after gait trining using the orthosis

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Gait training using a Knee Ankle Foot Orthosis with a mechanical knee joint using electro attractive material
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
40 years-old <=
Age-upper limit
79 years-old >=
Gender Male and Female
Key inclusion criteria Stroke patients in revovery phase, taking rehabilitation program at hoipitals, having gait trainig by physiotherapists using Knee Ankle Foot Orshoses
Key exclusion criteria Difficulty to understand oral instruction
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Sumiko
Middle name
Last name Yamamoto
Organization International University of Health and Welfare
Division name Graduate school
Zip code 107-8402
Address 4-1-26, Akasaka, Minato-ku, Tokyo, Japan
TEL +81-3-5574-3874
Email sumiko-y@iuhw.ac.jp

Public contact
Name of contact person
1st name Sumiko
Middle name
Last name Yamamoto
Organization International University of Health and Welfare
Division name Graduate school
Zip code 107-8402
Address 4-1-26, Akasaka, Minato-ku, Tokyo, Japan
TEL +81-3-5574-3874
Homepage URL
Email sumiko-y@iuhw.ac.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

Funding Source
Organization The Fujikura Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization International University of Health & Welfare
Address 4-1-26, Akasaka, MInato-ku, Tokyo, Japan ,
Tel 09046630750
Email sumiko-y@iuhw.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 千里リハビリテーション病院(大阪府)、海老名総合病院(神奈川県)、中伊豆リハビリテーションセンター(静岡県)、ねりま健育会病院(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 06 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 05 Month 31 Day
Date trial data considered complete
2020 Year 06 Month 30 Day
Date analysis concluded
2020 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 04 Day
Last modified on
2019 Year 04 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036618

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.