UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056341 |
|---|---|
| Receipt number | R000064334 |
| Scientific Title | Impact of Trunk Function and Lower Limb Paralysis on Independence in Activities of Daily Living in Patients With Stroke |
| Date of disclosure of the study information | 2024/12/02 |
| Last modified on | 2024/12/04 15:03:36 |
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Basic information
Public title
Impact of Trunk Function and Lower Limb Paralysis on Independence in Activities of Daily Living in Patients With Stroke
Acronym
Impact of Trunk Function and Lower Limb Paralysis on Independence in Activities of Daily Living in Patients With Stroke
Scientific Title
Impact of Trunk Function and Lower Limb Paralysis on Independence in Activities of Daily Living in Patients With Stroke
Scientific Title:Acronym
Impact of Trunk Function and Lower Limb Paralysis on Independence in Activities of Daily Living in Patients With Stroke
Region
| Japan |
Condition
Condition
Stroke patient
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the extent to which trunk function and lower limb paralysis affect ADL independence, both when evaluated individually and in combination, through stepwise analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Brunnstrom Recovery Stage
Trunk Impairment Scale
Functional Independence Measure
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with first-time stroke and hemiplegia
Key exclusion criteria
Subarachnoid hemorrhage, infratentorial lesions, the inability to comprehend verbal instructions, and lack of consent to participate in the study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takato |
| Middle name | |
| Last name | Nishida |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
4760014
Address
2-172 Fukinodai, Tokai-shi, Aichi
TEL
052-601-6000
tnishida@seijoh-u.ac.jp
Public contact
Name of contact person
| 1st name | Takato |
| Middle name | |
| Last name | Nishida |
Organization
Seijoh University
Division name
Faculty of Rehabilitation and Care
Zip code
476-8588
Address
2-172 Fukinodai, Tokai-shi, Aichi
TEL
052-601-6000
Homepage URL
tnishida@seijoh-u.ac.jp
Sponsor or person
Institute
Seijoh University
Institute
Department
Personal name
Funding Source
Organization
Seijoh 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
Seijoh University
Address
2-172 Fukinodai, Tokai-shi, Aichi
Tel
052-601-6000
tnishida@seijoh-u.ac.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
| 2024 | Year | 12 | Month | 02 | Day |
Related information
URL releasing protocol
https://www.medrxiv.org/content/10.1101/2024.12.02.24318305v1
Publication of results
Published
Result
URL related to results and publications
https://www.medrxiv.org/content/10.1101/2024.12.02.24318305v1
Number of participants that the trial has enrolled
51
Results
Across two regression models, the assessment of trunk and lower limb function in combination significantly improved the accuracy in reflecting ADL independence compared with the assessment of each function individually.
Results date posted
| 2024 | Year | 12 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Age (years) 71.5
Sex (male/female) 29/22
Stroke type (ischemic/hemorrhagic) 29/22
Hemiplegic side (left/right) 27/24
Days since stroke onset (days) 40
Participant flow
This cross-sectional study included patients with first-time stroke and hemiplegia who were admitted to Aichi-Pref Saiseikai Rehabilitation Hospital between July 2017 and October 2018.
The exclusion criteria were subarachnoid hemorrhage, infratentorial lesions, the inability to comprehend verbal instructions, and lack of consent to participate in the study.
The analysis included the data of 51 participants.
Adverse events
N/A
Outcome measures
Age
Sex
Stroke type
Paralyzed side
Days since stroke onset
Brunnstrom Recovery Stage for the lower extremities (BRS-LE)
Trunk Impairment Scale (TIS)
Functional Independence Measure (FIM)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 12 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study
Management information
Registered date
| 2024 | Year | 12 | Month | 02 | Day |
Last modified on
| 2024 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064334
