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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020567
Receipt No. R000023748
Scientific Title The effect of knee-ankle-foot orthosis with a novel knee-joint in post-stroke patients; A pilot study
Date of disclosure of the study information 2016/01/14
Last modified on 2016/01/30

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Basic information
Public title The effect of knee-ankle-foot orthosis with a novel knee-joint in post-stroke patients; A pilot study
Acronym The effect of knee-ankle-foot orthosis with a novel knee-joint
Scientific Title The effect of knee-ankle-foot orthosis with a novel knee-joint in post-stroke patients; A pilot study
Scientific Title:Acronym The effect of knee-ankle-foot orthosis with a novel knee-joint
Region
Japan

Condition
Condition Hemiplegic patients with brain injury
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of knee-ankle-foot orthosis with a novel knee jouint
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Surface EMG recordings before and after rehabilitation intervention
Key secondary outcomes video analysis, 10m-walk test, Fugl-Meyer Assessment, Brunnstrom stage, Modified Ashworth Scale, 6 minute walk test, Functional independence Measure (FIM), Frenchay Activities Index, Stroke Impact Scale

Base
Study type Interventional

Study design
Basic design Parallel
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 knee-ankle-foot orthosis (KAFO) with a novel knee joint. Intervention with the KAFO is scheduled 60 min/day, five times a week, for 8 weeks.
Interventions/Control_2 conventional knee-ankle-foot orthosis
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
20 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria hemiplegia due to stroke; stable condition; need a knee-ankle-foot orthosis; informed consent
Key exclusion criteria severe higher brain dysfunction; severe dementia; poor consciousness; previous gait dusturbance; severe sensory disturbance; severe skin disease
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Matsumoto
Organization Kagoshima University
Division name Dept. of Rehabilitation
Zip code
Address 3930-7 Takachiho, Makizono-cho, Kirishima City
TEL 0995-78-2538
Email shushu@m.kufm.kagoshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuji Matsumoto
Organization Kagoshima University
Division name Dept. of Rehabilitation
Zip code
Address 3930-7 Takachiho, Makizono-cho, Kirishima City
TEL 0995-78-2538
Homepage URL
Email shushu@m.kufm.kagoshima-u.ac.jp

Sponsor
Institute Kagoshima University
Institute
Department

Funding Source
Organization Kagoshima University
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 14 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2014 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 01 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
2016 Year 01 Month 14 Day
Last modified on
2016 Year 01 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023748

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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