UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017476 |
|---|---|
| Receipt number | R000020253 |
| Scientific Title | A feasibility traial of hand exoskeleton robot "Smove" which was designed to support impaired hand grip for post stroke patients in the daily living. |
| Date of disclosure of the study information | 2015/05/09 |
| Last modified on | 2021/05/12 23:14:55 |
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Basic information
Public title
A feasibility traial of hand exoskeleton robot "Smove" which was designed to support impaired hand grip for post stroke patients in the daily living.
Acronym
A feasibility traial of "Smove"
Scientific Title
A feasibility traial of hand exoskeleton robot "Smove" which was designed to support impaired hand grip for post stroke patients in the daily living.
Scientific Title:Acronym
A feasibility traial of "Smove"
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the safty and efficacy of the hand exoskeleton robot "Smove" which was designed to support the daily living of post CVD patients who have impaired uppuer limb movement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The normaloperation of "Smove" on patients.
The sefety of "Smove" on patients.
The improvement in the hand grip or pinch strength of the patients.
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Wear the hand exoskeleton device "Smove" for maximum 1 hour.
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
Stroke survivor (over 5 days after onset) who has paresis in his or her upper limb.
Who is over 20 years old age.
Who can communicate properly.
Whose recovery stage is
Brunnstrom stage=> III in the arm
Brunnstrom stage=> II in the hand
Who can smoothly wear the "Smove" by himself or by caregiver.
Who can make informed concent properly.
(If the patient can't sign on the agreement document, a witness confirm the patient's agreement orally and sign on the agreement document on behalf of the patient)
Key exclusion criteria
The patient whose condition is not suitable for recieving rehabilitation thearapy.
e.g.
JCS =>10, SBP>180, DBP<80, HR >120/min
Body temperature=> 38.0 degree Celsius.
The patient
who has strong pain in his impaired limb
who has strong spascity (Ashworth =>3)
who is recieving some therapy for spascity.
The patient who has other serious condition or allergy.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Hashizume |
Organization
Faculty of medical sciences, Kyushu University
Division name
Department of Advanced Medical Initiatives
Zip code
Address
3-1-1 Maidashi, Higasi-ku, Fukuoka City, Fukuoka, Japan
TEL
092-642-5592
mhashi@dem.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobutaka Mukae |
Organization
Faculty of medical sciences, Kyushu University
Division name
Neurosurgery
Zip code
Address
3-1-1 Maidashi, Higasi-ku, Fukuoka City, Fukuoka, Japan
TEL
092-642-5524
Homepage URL
mukae@ns.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
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
| 2015 | Year | 05 | Month | 09 | 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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2014 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 09 | Day |
Last modified on
| 2021 | Year | 05 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020253
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
