UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051090 |
|---|---|
| Receipt number | R000058263 |
| Scientific Title | Comparison of treatments for pusher behavior after stroke : a series of N-of-1 trials |
| Date of disclosure of the study information | 2023/05/17 |
| Last modified on | 2023/05/17 21:54:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of treatments for pusher behavior after stroke : a series of N-of-1 trials
Acronym
Comparison of treatments for pusher behavior
Scientific Title
Comparison of treatments for pusher behavior after stroke : a series of N-of-1 trials
Scientific Title:Acronym
Comparison of treatments for pusher behavior
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the most effective treatment for patients with pusher behavior by comparing visual feedback training (conventional therapy), prone position therapy and electrical stimulation therapy using N-of-1 trial. In addition, to conduct N-of-1 trials on multiple cases and investigate the therapeutic effects based on the severity of pusher behavior.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Scale for contraversive pushing and Burke lateropulsion scale before and after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Single cases are randomly assigned conventional therapy for Pusher behavior including visual feedback training; standing/gait training with a knee-ankle-foot orthosis presented using vertical cues, and prone position therapy, electrical stimulation therapy compared for about 3 weeks (15 times).
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
Among stroke patients who were admitted to Kohnan Hospital and prescribed rehabilitation, those who exhibited Pusher behavior (each subscale of Scale for contraversive pushing > 0)
Key exclusion criteria
(1)Age under 20 years old
(2)Patients with infratentorial lesion or bilateral hemispheric lesion
(3)Patients with difficulty performing exercises in standing position for more than 20 minutes (such as maintaining standing posture, standing balance, gait training, etc.)
However, those who can practice in a standing position for 20 minutes or more within 14 days will be eligible at that time.
(4)Patients contraindicated to electrical stimulation therapy (patients with a cardiac pacemaker, those with a history of seizures or those who are expected to have seizures, those with wounds or skin diseases at the electrical stimulation site, patients with malignant tumors, Those with sensory disturbance in the non-paralytic upper limbs, those with deep vein thrombosis)
(5)Patients who it is difficult to perform the prone position (tracheostomy, gastrostomy, and patients with extreme joint range of motion limitation in the hip joint or thoracolumbar spine)
(6)Subjects with an extremely high risk of falling if assisted by a single therapist or evaluator (cases weighing 80 kg or more, for whom assistance by a single caregiver is assumed to be difficult)
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazuto |
| Middle name | |
| Last name | Oki |
Organization
Kohnan Hospital Sendai Japan
Division name
Department of Rehabillitation medicine
Zip code
982-8523
Address
4-20-1,Nagamachiminami,Taihaku-ku,Sendai
TEL
022-248-2131
ookika0525@gmail.com
Public contact
Name of contact person
| 1st name | Kazuto |
| Middle name | |
| Last name | Oki |
Organization
Kohnan Hospital Sendai Japan
Division name
Department of Rehabillitation medicine
Zip code
982-8523
Address
4-20-1,Nagamachiminami,Taihaku-ku,Sendai
TEL
022-248-2131
Homepage URL
ookika0525@gmail.com
Sponsor or person
Institute
Kohnan Hospital Sendai Japan
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Fukushima Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kohnan Hospital Sendai Japan
Address
4-20-1,Nagamachiminami,Taihaku-ku,Sendai
Tel
022-248-2131
ookika0525@gmail.com
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 | 05 | Month | 17 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 10 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 05 | 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 | 05 | Month | 17 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058263
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
