UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050846 |
|---|---|
| Receipt number | R000057904 |
| Scientific Title | Interaction between rehabilitation engagement and physical characteristics in the recovery of upper limb function after stroke: A prospective cohort study |
| Date of disclosure of the study information | 2023/09/01 |
| Last modified on | 2026/02/04 18:34:26 |
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Basic information
Public title
Interaction between rehabilitation engagement and physical characteristics in the recovery of upper limb function after stroke: A prospective cohort study
Acronym
Interaction between rehabilitation engagement and physical characteristics in the recovery of upper limb function after stroke: A prospective cohort study
Scientific Title
Interaction between rehabilitation engagement and physical characteristics in the recovery of upper limb function after stroke: A prospective cohort study
Scientific Title:Acronym
Interaction between rehabilitation engagement and physical characteristics in the recovery of upper limb function after stroke: A prospective cohort study
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Early finger extension and shoulder abduction are known predictors of upper limb function recovery after stroke.
However, the interaction between these physical characteristics and rehabilitation engagement remains unclear.
Furthermore, their independent contributions-after adjusting for initial severity and cognitive function-have not been fully elucidated.
This prospective cohort study investigated how the interaction between admission physical characteristics (finger
extension or shoulder abduction) and rehabilitation engagement affects upper limb function at three months post-admission.
The primary hypothesis was the presence of a significant interaction between physical characteristics and engagement.
Basic objectives2
Others
Basic objectives -Others
prognosis
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Return to some dexterity on ARAT (ie, ARAT>=10) at 3 months after admission
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) 18years of age or older with a first-ever stroke (ischemic or hemorrhagic)
(2) presence of hemiparesis or monoparesis with independence in activities of daily living (ADL) prior to stroke onset
(3) Action Research Arm Test (ARAT) score 10 or less at admission
(4) an expected hospital stay of at least three months
Key exclusion criteria
(1) severe aphasia, cognitive impairment, or higher brain dysfunction that precluded accurate assessment
(2) severe medical comorbidities or intense pain that restricted participation in rehabilitation
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Kikui |
Organization
Hanshin Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
664-0003
Address
1-59-3 Ohno, Itami, Hyogo, Japan
TEL
072-783-3388
hanri-rihabili@mc-seifuen.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Sakuma |
Organization
Hanshin Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
664-0003
Address
1-59-3 Ohno, Itami, Hyogo, Japan
TEL
072-783-3388
Homepage URL
rehabili@hanshin-rh.jp
Sponsor or person
Institute
Hanshin Rehabilitation Hospital
Institute
Department
Personal name
Funding Source
Organization
nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hanshin Rehabilitation Hospital
Address
1-59-3 Ohno, Itami, Hyogo, Japan
Tel
072-783-3388
s-kikui@mc-seifukai.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 | 09 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective cohort study. From July 2023 to June 2027, Stroke patients whose affected limb ARAT < 10 on admission are consecutively recruited from an inpatient rehabilitation facility (Hanshin Rehabilitation Hospital) in Japan. Duration of recruitment would be prolonged, if the number of registered patients are not many enough. Outcome measures are an affected limb shoulder abduction and finger extension on admission and ARAT after 3 months.
Management information
Registered date
| 2023 | Year | 04 | Month | 14 | Day |
Last modified on
| 2026 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057904
