UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043325 |
|---|---|
| Receipt number | R000049460 |
| Scientific Title | Effect of using HAL waist type independence support for patients with acute stroke |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/02/14 23:22:33 |
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Basic information
Public title
Effect of using HAL waist type independence support for patients with acute stroke
Acronym
Effect of using HAL waist type independence support for patients with acute stroke
Scientific Title
Effect of using HAL waist type independence support for patients with acute stroke
Scientific Title:Acronym
Effect of using HAL waist type independence support for patients with acute stroke
Region
| Japan |
Condition
Condition
Acute stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examination of the effect of using HAL waist type independence support for patients with acute stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brunnstrom stage
Quadriceps muscle strength
National institute of heath stroke scale
Trunk function
Standing ability
Walking ability
Activities of daily living
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use group
Interventions/Control_2
Non-use group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who were hospitalized for an acute stroke
Those who do not meet the exclusion criteria
Key exclusion criteria
Those with reduced consciousness
Those who have difficulty maintaining a sitting position
Those who suffer from orthopedic disease, neuromuscular disease or heart disease and judge that the use of HAL waist type is inappropriate
Those who have an infectious disease
Those who have poor cognitive function and cannot understand the research
Those with significant higher brain dysfunction
Anderson / Dohi standards or those outside the resting range of the attending physician
Those who have difficulty wearing the HAL waist type
Those who the doctor or therapist in charge deems inappropriate
Those who are pregnant
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Iwata |
Organization
Suzukakaisei Hospital
Division name
Rehabilitation section
Zip code
513-8505
Address
112-1 Kou-cho,Suzuka-shi,Mie
TEL
0593751212
t-f-y.y-s@outlook.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Iwata |
Organization
Suzukakaisei Hospital
Division name
Rehabilitation section
Zip code
513-8505
Address
112-1 Kou-cho,Suzuka-shi,Mie
TEL
0593751212
Homepage URL
t-f-y.y-s@outlook.jp
Sponsor or person
Institute
Social Medical Corporation Houwakai Suzukakaisei Hospital Rehabilitation Section
Institute
Department
Personal name
Funding Source
Organization
None
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
Suzukakaisei Hospital
Address
112-1 Kou-cho,Suzuka-shi,Mie
Tel
0593751212
t-f-y.y-s@outlook.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
鈴鹿回生病院（三重県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 01 | 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
19
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
Brunnstrom stage
Quadriceps muscle strength (locomotive scan)
National Institute of Health Stroke Scale (NIHSS)
Trunk Control Test
Standing ability (Five times sit to stand test, foot pressure center locus)
Walking ability (Time Up and Go, 6m walking test, Functional Ambulation Categories)
Activities of Daily Living (Functional Independence Measure)
Modified Rankin Scale (mRS)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2020 | 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
| 2021 | Year | 02 | Month | 14 | Day |
Last modified on
| 2021 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049460
| 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 |
