UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053106 |
|---|---|
| Receipt number | R000060592 |
| Scientific Title | Comparison of standing and gait training for pusher behavior after stroke ; a series of N-of-1 Trials |
| Date of disclosure of the study information | 2023/12/18 |
| Last modified on | 2024/07/27 17:39:41 |
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Basic information
Public title
Comparison of standing and gait training for pusher behavior after stroke
Acronym
Comparison of physical therapy for pusher behavior after stroke
Scientific Title
Comparison of standing and gait training for pusher behavior after stroke ; a series of N-of-1 Trials
Scientific Title:Acronym
Comparison of physical therapy for pusher behavior after stroke
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the difference in treatment effects between standing and gait training with knee ankle foot orthosis.
Basic objectives2
Others
Basic objectives -Others
To discuss the treatment course of standing and gait training with knee ankle foot orthosis and the treatment course of different severities of pusher behavior.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Burke Lateropulsion Scale (BLS) before and after daily treatment
Key secondary outcomes
Clinical Assessment Scale for Contraversive Pushing (SCP) before and after daily treatment
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Standing training with a knee ankle foot orthosis and gait training with a knee ankle foot orthosis will be randomly assigned and performed 7times each for a total of 14days.
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
| 18 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patient with hemiplegia due to first hemisphere stroke (ischemic or hemorrhage)
Patient admitted to the convalescent rehabilitation ward of Kumamoto Kinoh Hospital
Patient with independent level walking ability before the disease
Patient with pusher behavior on admission evaluation (SCP subscale scores in each section of the scale were >0)
Patients capable of performing 20 minute of standing and gait training
Key exclusion criteria
Patients with illnesses or symptoms that clearly interfere with standing or gait training
Patients who weight more than 80kg
Patients who have difficulty responding to simple instructions
Patients who have been in the hospital for more than 80 days since the onset of stroke
Patients who are unable to obtain consent from themselves or their family members
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiko |
| Middle name | |
| Last name | Sannomiya |
Organization
Juryo Group Kumamoto Kinoh Hospital
Division name
Rehabilitation Department
Zip code
860-8518
Address
6-8-1 Yamamuro, Kita-ku, Kumamoto City, Kumamoto Prefecture
TEL
+81-96-345-8111
tanaka.y@juryo.or.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Tanaka |
Organization
Juryo Group Kumamoto Kinoh Hospital
Division name
Rehabilitation Department
Zip code
860-8518
Address
6-8-1 Yamamuro, Kita-ku, Kumamoto City, Kumamoto Prefecture
TEL
+81-96-345-8111
Homepage URL
tanaka.y@juryo.or.jp
Sponsor or person
Institute
Juryo Group Kumamoto Kinoh Hospital
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukushima Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juryo Goup Kumamoto Kinoh Hospital
Address
6-8-1 Yamamuro, Kita-ku, Kumamoto City, Kumamoto Prefecture
Tel
+81-96-345-8111
tanaka.y@juryo.or.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 18 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 13 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 12 | Month | 14 | Day |
Last modified on
| 2024 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060592
