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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009269
Receipt No. R000010887
Scientific Title Understanding the upper limb motor control and motor learning with KINARM exoskeleton robot
Date of disclosure of the study information 2012/11/06
Last modified on 2019/04/01

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Basic information
Public title Understanding the upper limb motor control and motor learning with KINARM exoskeleton robot
Acronym Understanding the upper limb motor control and motor learning with KINARM exoskeleton robot
Scientific Title Understanding the upper limb motor control and motor learning with KINARM exoskeleton robot
Scientific Title:Acronym Understanding the upper limb motor control and motor learning with KINARM exoskeleton robot
Region
Japan

Condition
Condition Patients with upper limb impairments and healthy adults
Classification by specialty
Rehabilitation medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To understand the mechanism of upper limb motor control and motor learning using an exoskeleton robot
Basic objectives2 Others
Basic objectives -Others Movement analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Movements parameters measured with KINARM exoskeleton robot
Key secondary outcomes Neurophysiological evaluations (EMG, EEG, TMS)

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 Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Upper limb movement tasks on KINARM exoskeleton robot
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria [Patients]
Impairments in the upper limb
Able to keep sitting position
No apparent cognitive disturbance
Preserved shoulder ROM to perform motor tasks on KINARM
Consent to participate in the study

[Healthy adults]
No past history of musculoskeletal impairments in the upper limbs and neurological diseases
Consent to participate in the study
Key exclusion criteria [Patients]
Past history of seizure
Pacemaker
Implanted shunt and clipping


[Patients and healthy adults]
Contraindications for upper limb exercise.
1. Severe heart diseases: unstable angina, recent myocardial infarction, decompensated congestive heart failure, severe arrhythmia, severe aortic stenosis, active myocarditis, endocarditis etc
2. Uncontrollable hypertension
3. Systemic diseases or fever
4. Recent pulmonary embolism, acute cor pulmonale, severe pulmonary hypertension
5. Severe liver and/or kidney dysfunction
6. Severe orthopedic problems in the upper limb
7. Severe cognitive disturbance, severe psychiatric diseases
8. Other metabolic diseases (acute thyroiditis etc)
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yohei Otaka
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address 35 Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yohei Otaka
Organization Keio University School of Medicine
Division name Department of Rehabilitation Medicine
Zip code
Address
TEL 03-5363-3833
Homepage URL
Email

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization None
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 慶應義塾大学病院 (KEIO UNIVSRSITY HOSPITAL)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 06 Day

Related information
URL releasing protocol No URL for protocol
Publication of results Published

Result
URL related to results and publications https://jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-015-0059-8
Number of participants that the trial has enrolled 102
Results
The robot-derived measures could successfully differentiate between the paretic arm and the non-paretic arm and were valid in comparison to the well-established clinical scales.
Results date posted
2019 Year 04 Month 01 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2015 Year 08 Month 12 Day
Baseline Characteristics
NA
Participant flow
NA
Adverse events
No adverse events related to the study
Outcome measures
Kinematic indices derived from the KINARM exoskeleton device.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 07 Month 30 Day
Date of IRB
2012 Year 07 Month 30 Day
Anticipated trial start date
2012 Year 11 Month 07 Day
Last follow-up date
2018 Year 01 Month 01 Day
Date of closure to data entry
2018 Year 06 Month 30 Day
Date trial data considered complete
2018 Year 06 Month 30 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2012 Year 11 Month 06 Day
Last modified on
2019 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010887

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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