UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022410 |
|---|---|
| Receipt number | R000025826 |
| Scientific Title | A study of safety and efficacy of HAL for hemiparesis due to the brain disease in the research project of [A study for efficacy of functional recovery therapy using the Robot Suit HAL for the motor function disorder due to the cerebrospinal diseases, and construction of regional cooperation program of HAL] |
| Date of disclosure of the study information | 2016/05/23 |
| Last modified on | 2019/11/25 18:00:44 |
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Basic information
Public title
A study of safety and efficacy of HAL for hemiparesis due to the brain disease in the research project of [A study for efficacy of functional recovery therapy using the Robot Suit HAL for the motor function disorder due to the cerebrospinal diseases, and construction of regional cooperation program of HAL]
Acronym
A study of safety and efficacy of HAL for hemiparesis due to the brain disease
Scientific Title
A study of safety and efficacy of HAL for hemiparesis due to the brain disease in the research project of [A study for efficacy of functional recovery therapy using the Robot Suit HAL for the motor function disorder due to the cerebrospinal diseases, and construction of regional cooperation program of HAL]
Scientific Title:Acronym
A study of safety and efficacy of HAL for hemiparesis due to the brain disease
Region
| Japan |
Condition
Condition
Stroke (Cerebral infarction, Cerebral hemorrhage)
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the safety and efficacy of using the HAL (HAL group) to compare the difference of recovery process about gait disorder, motor dysfunction and activities of daily living with conventional physiotherapy (Control group) in individuals brain disease with the hemiparesis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Functional Ambulation Category (FAC)
Key secondary outcomes
Brunnstrom stage (BRs)
12grade hemiplesia functional test
NIHSS
Fugl-meyer assessnment (FMA)
6m-Gait speed, Stride, Cadence, Gait-form
Gait distance for 6 min
modified Rankin Scale (mRS)
Barthel Index (BI)
motor Functional Independence Measure (motor FIM)
MMSE
Duration of hospitalization and research
Frequency of HAL treatment and conventional physiotherapy
Adverse event
EMG
TMS-MEP
F wave, H wave
EEG
fMRI, resting-state fMRI, DTI
Oxidatiove stress index
Platelet aggregation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
HAL group performed gait training using the HAL 3 times a week with a total of 9 HAL training sessions (3 weeks).
Interventions/Control_2
Conventional group performed conventional physical therapy 3 times a week with a total of 9 conventional physical therapy sessions (3 weeks).
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
1)Hemiparesis resulting from unilateral ischemic or hemorrhagic stroke in the acute phase.
2)Age:40-80 years old
3)Time since stroke onset within 7-14 days.
4)Functional Ambulation Category (FAC) 1-2
5)Patient can ensure more than 3 weeks from intervention initiation.
6)Patient with a score of more than 4 on the FAC prior to stroke.
7)Patient can consent by a document. If the handwriting is difficult due to the paralysis, it is assumed to obtain a document consent from ghost-writing user.
8)Patient who can be suitable for HAL (only HAL group)
Key exclusion criteria
1)It is difficult to perform the voluntary movement of the limbs in accordance with the instructions due to the disturbance of consciousness.
2)Patients has a complication, for example, severe cardiac disease and musculoskeletal system which can disturb the treatment using HAL.
3)Patients who investigator or sub investigator deemed inappropriate In this clinical trial.
4)Patients received magnetic stimulation, electrical stimulation and so no, neuromodulation therapy prior to the this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Matsumura |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Neurosurgery
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki Japan
TEL
029-853-3220
a-matsumur@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Aiki |
| Middle name | |
| Last name | Marushima |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Neurosurgery and Stroke
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki Japan
TEL
029-853-3220
Homepage URL
aiki.marushima@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
T-CReDO
Address
1-1-1 Tennodai, Tsukuba, Ibaraki Japan
Tel
029-853-3220
aiki.marushima@md.tsukuba.ac.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
筑波大学附属病院 (茨城県) (University of Tsukuba Hospital)
関連病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 23 | 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
| 2016 | Year | 09 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 09 | Month | 21 | 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
| 2016 | Year | 05 | Month | 23 | Day |
Last modified on
| 2019 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025826
