UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012760 |
|---|---|
| Receipt number | R000014909 |
| Scientific Title | Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with ambulation disability after stroke. |
| Date of disclosure of the study information | 2014/01/07 |
| Last modified on | 2017/07/10 10:33:09 |
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Basic information
Public title
Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with ambulation disability after stroke.
Acronym
Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with ambulation disability after stroke.
Scientific Title
Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with ambulation disability after stroke.
Scientific Title:Acronym
Exploratory study of the Hybrid Assistive Limb (HAL), a wearable robot, on improving mobility in patients with ambulation disability after stroke.
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate efficacy and problem about Motor function and Activity of Daily Living for disabled persons using Hybrid Assistive Limb
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
2 minutes walk test
10m walking test
Functional Ambulation Categories
Key secondary outcomes
Step length
Cadence
Physiological Cost Index (PCI)
Fugl-Meyer Assessment of Motor Recovery after Stroke
Functional Balance Scale
modified Ashworth Scale
Knee-extension torque
Functional Independence Measure (FIM)
Functional Movement Scale
EQ5D
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 | Maneuver |
Interventions/Control_1
Participants will do trial fitting of HAL and then conduct 20 minutes ambulation exercises with HAL, 5 times a week for 5 weeks. Participants will take 40 min usual physical therapy.
Interventions/Control_2
Patients medical records who took 60 min usual physical therapy 5 time a week for 5 weeks will collect.
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient with first stroke
Over 3 months after onset
Less than 10% of the 2 minutes walking test improvement rate in continuous 3 weeks
Able to sit in Wheel chair at least 30 minutes
Key exclusion criteria
Lesion of cerebellum or brain stem
Subarachnoid hemorrhage
Needs severe risk control in physical therapy
Severe cognitive dysfunction
Severe Higher Brain Dysfunction
Severe sensory aphasia
With severe contracture and deformities in lower limb
Body weight above 80kg
User of the active implantable medical devise
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masafumi Mizukami |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Graduated School of Health Sciences
Zip code
Address
4669-2 Ami Ami-machi Ibaraki Japan
TEL
029-840-2162
mizukami@ipu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masafumi Mizukami |
Organization
Ibaraki Prefectural University of Health Sciences
Division name
Graduated School of Health Sciences
Zip code
Address
4669-2 Ami Ami-machi Ibaraki Japan
TEL
029-840-2162
Homepage URL
mizukami@ipu.ac.jp
Sponsor or person
Institute
Ibaraki Prefectural University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
Ibaraki Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
University of Tsukuba
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
茨城県立医療大学付属病院
Ibaraki Prefectural University of Health Sciences Hospital
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2013 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2015 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 01 | Month | 06 | Day |
Last modified on
| 2017 | 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=R000014909
| Research Plan | |
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| Registered date | File name |
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