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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031194
Receipt No. R000035611
Scientific Title The effects of gait training using an ankle-foot orthosis with a modular exoskeletal robot actuated by pneumatic artificial muscles
Date of disclosure of the study information 2018/02/07
Last modified on 2019/08/10

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Basic information
Public title The effects of gait training using an ankle-foot orthosis with a modular exoskeletal robot actuated by pneumatic artificial muscles
Acronym The effects of gait training using a powered ankle-foot orthosis
Scientific Title The effects of gait training using an ankle-foot orthosis with a modular exoskeletal robot actuated by pneumatic artificial muscles
Scientific Title:Acronym The effects of gait training using a powered ankle-foot orthosis
Region
Japan

Condition
Condition Stroke patients with hemiparesis
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The treatment effects of hemiparetic gait training using an ankle-foot orthosis with a modular exoskeletal robot
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The changes of ankle movements during hemiparetic gait just after and after 1 month of treatments
Key secondary outcomes The kinematic changes during hemiparetic gait
The changes of EMG patterns during hemiparetic gait
Muscular powers during stepping
Gait speeds
Gait Assessment and Intervention Tool scores

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Ankle robot gait trainings (15 sessions, 30 minutes/session)
Interventions/Control_2 Conventional gait training (15 sessions, 30 minutes/session)
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

Not applicable
Gender Male and Female
Key inclusion criteria Passive ankle range of motion of 40 degrees or more
The ankle proprioceptive ability of about 10 degrees
Independent indoor walking with an ankle-foot orthosis
Key exclusion criteria Sensory loss of paretic foot
Neuromuscular or joint diseases affecting gait
Severe aphasia or cognitive disorders
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kimitaka
Middle name
Last name Hase
Organization Kansai Medical University
Division name Physical Medicine of Rehabilitation
Zip code 573-1191
Address 3-1 Shinmachi 2 Chome, Hirakata City, Osaka
TEL +81-72-804-0101
Email hasekim@hirakata.kmu.ac.jp

Public contact
Name of contact person
1st name Kimitaka
Middle name
Last name Hase
Organization Kansai Medical University
Division name Physical Medicine of Rehabilitation
Zip code 573-1191
Address 3-1 Shinmachi 2 Chome, Hirakata City, Osaka
TEL +81-72-804-0101
Homepage URL
Email hasekim@hirakata.kmu.ac.jp

Sponsor
Institute Kansai Medical University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Ethics committees of the Kansai Medical University hospital
Address 2-3-1, Shinmachi, Hirakata, Osaka
Tel +81-72-804-0101
Email kmu@esct.bvits.com

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
2018 Year 02 Month 07 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 19
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 Completed
Date of protocol fixation
2017 Year 12 Month 08 Day
Date of IRB
2018 Year 02 Month 20 Day
Anticipated trial start date
2018 Year 03 Month 19 Day
Last follow-up date
2019 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 02 Month 07 Day
Last modified on
2019 Year 08 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035611

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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