UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025591 |
|---|---|
| Receipt number | R000029379 |
| Scientific Title | Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation |
| Date of disclosure of the study information | 2017/01/13 |
| Last modified on | 2020/03/30 11:00:23 |
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Basic information
Public title
Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation
Acronym
Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation
Scientific Title
Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation
Scientific Title:Acronym
Effectiveness of using a hybrid assistive limb (HAL) in patients with stroke, spinal cord injury, or knee/hip joint injury at acute phase rehabilitation
Region
| Japan |
Condition
Condition
stroke, spinal cord injury, knee/hip joint injury
Classification by specialty
| Orthopedics | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aim to investigate the safety and efficacy of HAL in rehabilitation medicine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of myopotential signals of each lower limb muscle
Key secondary outcomes
1)video image
2)range of motion of the joints in the lower extremities
3)muscle strength of the lower extremities
4)cardiopulmonary function (heart rate, blood pressure, rating of perceived exertion(Borg Scale))
5)satisfaction with the assistance in mobility provided by HAL
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
to walk 10m wearing HAL at the first day and the last day of rehabilitation
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
Subjects who are diagnosed as stroke, spinal cord injury, or knee/hip joint injury
Subjects must satisfy the following conditions for inclusion:
1.who have difficulty walking and cannot walk independently
2.who are fully informed and understand about this study, and then provide the written voluntary consent to participation
Key exclusion criteria
The following patients will be excluded:
1.who are under 20 years old
2.who are determined to have difficulty understanding due to dementia ,higher brain dysfunction and the other reason
3.who have poorly controlled hypertension, heart failure, osteoporosis, and the other disease
4.who are in life-threatening medical condition, and are forbidden exercise by a doctor
5.who are determined as unsuitable subjects by investigators for various other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuo Chosa |
Organization
University of Miyazaki Hospital
Division name
Rehabilitation unit and Orthopaedic Surgery
Zip code
Address
5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL
0985-85-0986
seikei@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Etsuo Chosa |
Organization
University of Miyazaki Hospital
Division name
Rehabilitation unit and Orthopaedic Surgery
Zip code
Address
5200 Kihara Kiyotake Miyazaki 889-1692 JAPAN
TEL
0985-85-0986
Homepage URL
seikei@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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 | 01 | Month | 13 | 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
| 2013 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 14 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 10 | Day |
Last modified on
| 2020 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029379
