UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026678 |
|---|---|
| Receipt number | R000027008 |
| Scientific Title | Home-based program using single-joint hybrid assistive limb for upper-limb disability in chronic stroke:a pilot study |
| Date of disclosure of the study information | 2017/03/24 |
| Last modified on | 2019/01/05 22:18:42 |
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Basic information
Public title
Home-based program using single-joint hybrid assistive limb for upper-limb disability in chronic stroke:a pilot study
Acronym
Home-based program using single-joint hybrid assistive limb for upper-limb disability in chronic stroke:a pilot study
Scientific Title
Home-based program using single-joint hybrid assistive limb for upper-limb disability in chronic stroke:a pilot study
Scientific Title:Acronym
Home-based program using single-joint hybrid assistive limb for upper-limb disability in chronic stroke:a pilot study
Region
| Japan |
Condition
Condition
Chronic stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this pilot study is to evaluate the effect of the home-based program using single-joint hybrid assistive limb for upper-limb disability in chronic stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Motor Activity Log
Key secondary outcomes
Action Research Arm Test
Fugl-Meyer Assessment
Wolf Motor Function Test
Triaxial Accelerometry
Near-Infrared Spectroscopy
Canadian Occupational Performance Measure
Patient's global impression scale
Clinical global impression scale
Self-efficacy measure
SF-36
Apathy Scale
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 | Other |
Interventions/Control_1
(Period of intervention)
Visiting home rehabilitation:4 weeks
Telephone and visiting follow:8 weeks
Total:12 weeks
(Interventions)
Visiting home rehabilitation using HAL-SJ 2 times a week(4weeks) and providing rehabilitation practice,and then,follow using telephone,and visiting(8 weeks)
(Intervention time)
HAL-SJ training session time:30 minutes
Conventional occupational therapy:30 minutes
Total 60 minutes
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
| 40 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who are chronic stroke(6 month pass) and from 40 years old to 75 years old.
Motor weakness in upper limb(Brunnstrom recovery stage is between 3-6).
The patients who do not have subluxation of shoulder and elbow.
The patients who do not have serious pain on paralysis upper limb.
The patients who can sign agreement consent.
The patients who can be suitable for HAL-SJ.
The patients who can be received this program.
Key exclusion criteria
without uncontrolable circulation diseases,pulmonary diseases,and kidney disease.
without cognitive function disorder.
without moderate joint disorder and joint contracture..
without moderate involuntary movement, ataxia and abnormal reflexes.
without skin disease.
without mental disease.
the doctor judges that when it is determind in participation of this program.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinari Uehara |
Organization
Fukuoka University Hospital
Division name
Center for Preventive,Anti-aging and Regenerative Medicine
Zip code
Address
7-45-1Nanakuma,Jounan,Fukuoka
TEL
092-801-1011
ueharay@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Hyakutake |
Organization
Fukuoka University Hospital
Division name
Department of Neurosurgery and Rehabilitation
Zip code
Address
7-45-1Nanakuma,Jounan,Fukuoka
TEL
092-801-1011
Homepage URL
hyakutake0081@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University Hospital
Department of Neurosurgery
Center for Preventive,Anti-aging and Regenerative Medicine
Institute
Department
Personal name
Funding Source
Organization
Fukuoka University Hospital
Department of Neurosurgery
Center for Preventive,Anti-aging and Regenerative Medicine
Organization
Division
Category of Funding Organization
Other
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
| 2017 | Year | 03 | Month | 24 | 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 | 08 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 24 | Day |
Last modified on
| 2019 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027008
| 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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