UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049806 |
|---|---|
| Receipt number | R000056727 |
| Scientific Title | Recovery process of vertical perception and daily living in stroke: A retrospective cohort study |
| Date of disclosure of the study information | 2022/12/16 |
| Last modified on | 2022/12/16 14:45:30 |
* 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
Recovery process of vertical perception and daily living in stroke: A retrospective cohort study
Acronym
Recovery process of vertical perception and daily living in stroke: A retrospective cohort study
Scientific Title
Recovery process of vertical perception and daily living in stroke: A retrospective cohort study
Scientific Title:Acronym
Recovery process of vertical perception and daily living in stroke: A retrospective cohort study
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We aimed to investigate the characteristics of the longitudinal recovery process of SPV and activities of daily living after stroke.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study was to investigate the characteristics of the longitudinal recovery process of SPV and activities of daily living in cases of Pusher and hemispatial neglect.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SPV
SPV-EO
FIM
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 60 | years-old | < |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Among the 1,620 persons with stroke admitted to Takenotsuka Noshinkei Rehabilitation Hospital between April 2017 and November 2022, 109 with VP measurements were enrolled after applying the inclusion and exclusion criteria.
Key exclusion criteria
The exclusion criteria were brainstem and cerebellar lesions, multiple cerebral infarctions, hydrocephalus, poor understanding of instructions, and orthopedic musculoskeletal findings, such as fractures, rheumatism, and pain, requiring treatment at the physicians discretion.
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
Ryotokuji University
Division name
physiotherapy
Zip code
279-8567
Address
5-8-1, Akemi, Urayasu, Chiba
TEL
+818012079205
koutas966@gmail.com
Public contact
Name of contact person
| 1st name | Kota |
| Middle name | |
| Last name | Sawa |
Organization
Ryotokuji University
Division name
Physiotherapy
Zip code
279-8567
Address
5-8-1, Akemi
TEL
+818012079205
Homepage URL
koutas966@gmail.com
Sponsor or person
Institute
Ryotokuji University
Institute
Department
Personal name
Funding Source
Organization
Ryotokuji University
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
Ryotokuji University
Address
5-8-1, Akemi
Tel
+818012079205
koutas966@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
| 2022 | Year | 12 | Month | 16 | Day |
Related information
URL releasing protocol
https://www.researchsquare.com/article/rs-1798592/v1
Publication of results
Unpublished
Result
URL related to results and publications
https://www.researchsquare.com/article/rs-1798592/v1
Number of participants that the trial has enrolled
109
Results
Groups B and C had larger SPV variability errors than group A. Furthermore, group B showed a significant improvement in variability errors after 1 month. Furthermore, there was a correlation between the initial SPV eye-opening variability errors and total FIM after 1 month of pusher patients with unilateral spatial neglect in group C.
Results date posted
| 2022 | Year | 12 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Sixteen, 63, and 30 patients were classified into groups A, B, and C, respectively. No significant differences in age, sex, days from the onset of SPV measurement, BRS, and the Pusher and USN severity were found in each group (Table 1).
Participant flow
Among the 1,620 persons with stroke admitted to Takenotsuka Noshinkei Rehabilitation Hospital between April 2017 and November 2022, 109 with VP measurements were enrolled after applying the inclusion and exclusion criteria
Adverse events
None
Outcome measures
Total functional independence measure (FIM), initially and after 1 month. The SPV mean and standard deviation values indicated the directional and variability errors, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 12 | Month | 16 | Day |
Other
Other related information
Overall, 109 patients with stroke were enrolled. Clinical assessments included the SPV and total functional independence measure (FIM), initially and after 1 month. The SPV mean and standard deviation values indicated the directional and variability errors, respectively. Participants were categorized as follows: group A had directional and variability errors within the standard values, group B had directional errors within the standard value range and variability errors greater than the standard values, and group C had directional and variability errors greater than the standard values. In addition, a two-way analysis of variance was performed for SPV and FIM scores (P < 0.05).
Management information
Registered date
| 2022 | Year | 12 | Month | 16 | Day |
Last modified on
| 2022 | 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=R000056727
