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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000021367
Receipt No. R000024643
Scientific Title Evaluation on a robotic ankle-foot orthosis with the support of plantar flexion motion
Date of disclosure of the study information 2016/04/01
Last modified on 2016/03/06

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Basic information
Public title Evaluation on a robotic ankle-foot orthosis with the support of plantar flexion motion
Acronym Robotic ankle-foot orthosis with plantar flexion support
Scientific Title Evaluation on a robotic ankle-foot orthosis with the support of plantar flexion motion
Scientific Title:Acronym Robotic ankle-foot orthosis with plantar flexion support
Region
Japan

Condition
Condition Hemiparesis patients (right ankle) with stroke or other neurological diseases
Classification by specialty
Neurology Neurosurgery Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Performance evaluation of the robotic ankle-foot orthosis with plantar flexion support
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measurement of body movement and EMG such as limbs, torso, and floor reaction force during walking with the the robotic AFO
Key secondary outcomes

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Educational,Counseling,Training
Type of intervention
Device,equipment
Interventions/Control_1 Supporting the plantar flexion motion by using the robotic ankle-foot orthosis
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
20 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria - hemiparesis patients with stroke or other neurological diseases
- able to walk without AFO in a short distance
- Able to use AFO, such as double Klenzak ankle joint brace
- Up to 80kg weight, 26.5cm foot length
- No mental health problem, and sufficient to perform the experiment
Key exclusion criteria - Any patients with spasticity and solid contraction interfere with keeping standing posture
- Patient with dizziness or blood pressure drop problems during the gait training
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Yamazaki
Organization University of Tsukuba
Division name Department of Orthopaedics Surgery, Faculty of Medicine
Zip code
Address 2-1-1 Amakubo, Tsukuba, Ibaraki
TEL 029-853-3219
Email masashiy@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Suzuki
Organization University of Tsukuba
Division name Center for Cybernics Resaerch
Zip code
Address 1-1-1 Tennodai, Tsukuba, Ibaraki
TEL 029-853-5761
Homepage URL
Email kenji@ieee.org

Sponsor
Institute University of Tsukuba Hospital
Institute
Department

Funding Source
Organization Center for Cybernics Research, University of Tsukuba
Organization
Division
Category of Funding Organization
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 04 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
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 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 03 Month 06 Day
Last modified on
2016 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024643

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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