UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044593 |
|---|---|
| Receipt number | R000050936 |
| Scientific Title | Can the aggressive gait training contribute to reduce pusher behavior in stroke patients? |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/06/19 14:52:09 |
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Basic information
Public title
Can the aggressive gait training contribute to reduce pusher behavior in stroke patients?
Acronym
Can the aggressive gait training contribute to reduce pusher behavior in stroke patients?
Scientific Title
Can the aggressive gait training contribute to reduce pusher behavior in stroke patients?
Scientific Title:Acronym
Aggressive gait training contribute to the reduce pusher behavior
Region
| Japan |
Condition
Condition
Hemiplegic stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal whether robot-assisit gait training using the Welwalk can reduce pusher behavior in hemiplegic stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of reduce of Burke Lateropulsion Scale after two weeks from start of intervention.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Robot-assisted Gait Training Using Welwalk (2 weeks)
Interventions/Control_2
Conventional gait training using Knee-Ankle- Foot orthosis (2 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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Stroke hemiplegic patients with pusher behavior who admitted to the convalescent ward
Key exclusion criteria
Subjects who can not walk using robots device or Knee-Ankle-Foot orthosis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ueno |
| Middle name | |
| Last name | Shingo |
Organization
Junwakai Memorial Hospital
Division name
Department of Rehabilitation
Zip code
880-2112
Address
1119, Komatsu, Miyazaki city
TEL
0985-47-5555
shingo_ueno@junwakai.com
Public contact
Name of contact person
| 1st name | Ueno |
| Middle name | |
| Last name | Shingo |
Organization
Junwakai Memorial Hospital
Division name
Department of Rehabilitation
Zip code
880-2112
Address
1119, Komatsu, Miyazaki city
TEL
0985-47-5555
Homepage URL
shingo_ueno@junwakai.com
Sponsor or person
Institute
Junwakai Memorial 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
none
Address
none
Tel
none
none
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
| 2021 | Year | 07 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 07 | Month | 06 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 12 | 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 | 06 | Month | 19 | Day |
Last modified on
| 2021 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050936
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| Registered date | File name |
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