UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030678 |
|---|---|
| Receipt number | 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 | 2023/07/10 18:09:48 |
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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
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
miyata@omichikai.or.jp
Sponsor or person
Institute
ATR Computational Neuroscience Labs, Dept. of Brain Robot Interface
Institute
Department
Personal name
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
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
| Delay expected |
Results Delay Reason
Fixing the Exoskeletal robot's malfunction
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
| 2023 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035026
