UMIN-CTR Clinical Trial

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	Terminated
Date of protocol fixation	2018 Year 05 Month 25 Day
Date of IRB	2017 Year 08 Month 04 Day
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	2022 Year 10 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036618