UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030678
Receipt No. R000035026
Scientific Title Clinical Application of an Exoskeleton Robot for patients with Stroke
Date of disclosure of the study information 2018/01/05
Last modified on 2019/07/01

* 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 Application of an Exoskeleton Robot for patients with Stroke
Acronym Clinical Application of an Exoskeleton Robot for patients with Stroke
Scientific Title Clinical Application of an Exoskeleton Robot for patients with Stroke
Scientific Title:Acronym Clinical Application of an Exoskeleton Robot for patients with Stroke
Region
Japan

Condition
Condition Stroke
Classification by specialty
Neurology Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 It is commonly accepted that task-oriented training is beneficial to improve upper extremity function of stroke patients. However recent randomized controlled trials have failed to prove dose dependent effect of such intervention (Weinstein, JAMA 2015, Lang, Ann Neurol 2016). Although quality of intervention might be another determinant of the effective training, objective description of such intervention remains unclear. To establish evidence based rehabilitative strategies, it is ideal to record quality and quantity of each single practice. We assumed that exoskeleton robot could be a efficient and safe tool for providing real-time monitoring and feedback during upper extremity practice.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Torques of upper extremity wearing the exoskeleton robot
Key secondary outcomes Fugl-Meyer Assessment, Nine-hole Peg Test, Action Research Arm Test, grip power, Modified Ashworth Scale, kinematic data from the exoskeleton robot and motion analysis system

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 A newly developed upper extremity exoskeleton robot driven by pneumatic artificial muscles can assist shoulder flexion with various degrees of conditions.Subjects were instructed to flex the shoulder from 0 to 120 degrees with elbow extended, forearm and wrist neutral with each degree of assistance. Torques of the shoulder and elbow and wrist were measured during the task to evaluate relationship between subjects' effort and abnormal flexor synergy of the paretic upper extremity.
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

Not applicable
Gender Male and Female
Key inclusion criteria Hemiparetic patients with stroke
Key exclusion criteria dementia(MMSE<24), severe aphasia, severe sensory disturbance or pain, contracture of the upper extremity, skin trouble
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Miyai
Organization Morinomiya Hospital
Division name Neurorehabilitation Research Institute
Zip code 5360025
Address 2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
TEL 06-6969-0111
Email miyai@omichikai.or.jp

Public contact
Name of contact person
1st name Misako
Middle name
Last name Miyata
Organization Morinomiya Hospital
Division name Officer
Zip code 5360025
Address 2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
TEL 06-6969-0111
Homepage URL
Email miyata@omichikai.or.jp

Sponsor
Institute ATR Computational Neuroscience Labs, Dept. of Brain Robot Interface
Institute
Department

Funding Source
Organization NICT: National Institute of Information and Communications Technology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization IRB
Address 2-1-88 Morinomiya, Joto-ku, Osaka City, Osaka, Japan
Tel 06-6969-0111
Email nrri-jimu@omichikai.or.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 森之宮病院(大阪府)

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 05 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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 08 Day
Date of IRB
2017 Year 02 Month 08 Day
Anticipated trial start date
2018 Year 01 Month 05 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 12 Month 31 Day
Date trial data considered complete
2021 Year 12 Month 31 Day
Date analysis concluded
2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 01 Month 04 Day
Last modified on
2019 Year 07 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035026

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.