UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060093 |
|---|---|
| Receipt number | R000068726 |
| Scientific Title | Therapeutic effects of delayed visual feedback on cerebrovascular disorder patients exhibiting the pusher behavior: A double-blind randomized crossover trial |
| Date of disclosure of the study information | 2025/12/22 |
| Last modified on | 2025/12/16 00:26:20 |
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Basic information
Public title
A study to investigate the effect of rehabilitation using visual information for people who have difficulty feeling body leaning after stroke.
Acronym
A study to investigate the effects of rehabilitation using visual information on stroke survivors
Scientific Title
Therapeutic effects of delayed visual feedback on cerebrovascular disorder patients exhibiting the pusher behavior: A double-blind randomized crossover trial
Scientific Title:Acronym
A double-blind randomized crossover trial
Region
| Japan |
Condition
Condition
cerebrovascular disease
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of intervention with delayed visual feedback on patients with cerebrovascular disease associated with Pusher behavior.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Burke lateropulsion scale(BLS) (before intervention, after intervention1, after intervention2)
Key secondary outcomes
Scale for Contraversive Pushing (SCP)
Subjective postural vertical(SPV)
Trunk Control Test (TCT)
Eye opening, eye closing, left and right center of gravity trajectory length, left and right center of gravity shift distance, and left and right maximum load ratio using a seat pressure gauge.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Delayed visual feedback. The duration is 1 week, with 30 weight transfers to the nonparalyzed side per day.
Interventions/Control_2
Visual feedback. The duration is 1 week, with 30 weight transfers to the nonparalyzed side per day.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with hemiplegia due to first stroke with or suspected of having Pusher behavior who are hospitalized in a convalescent ward.
Able to understand simple instructions.
Key exclusion criteria
Patients with concurrent disability of submental lesions, bilateral disability, psychiatric disorders, pre-existing orthopedic diseases that interfere with ADL, and sequelae of hemiplegia after stroke.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Kato |
Organization
Moriyama Neurological Center Hospital
Division name
Department of Rehabilitation
Zip code
1340088
Address
7-12-7 Nishikasai, Edogawa, Tokyo
TEL
03-3675-1211
reha-reha@moriyamaikai.or.jp
Public contact
Name of contact person
| 1st name | Yuichi |
| Middle name | |
| Last name | Kato |
Organization
Moriyama Neurological Center Hospital
Division name
Department of Rehabilitation
Zip code
1340088
Address
7-12-7 Nishikasai, Edogawa, Tokyo
TEL
03-3675-1211
Homepage URL
yu1ii10122101@outlook.com
Sponsor or person
Institute
other
Institute
Department
Personal name
Funding Source
Organization
self-purchase
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
N/A
Address
N/A
Tel
N/A
N/A
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
| 2025 | Year | 12 | Month | 22 | 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
| 2025 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 12 | Month | 16 | Day |
Last modified on
| 2025 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068726
