UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062843 |
|---|---|
| Receipt number | R000071940 |
| Scientific Title | Association Between Acceptance of Disability and Psychosocial Factors in Patients With Stroke During Convalescent Rehabilitation |
| Date of disclosure of the study information | 2026/09/08 |
| Last modified on | 2026/09/08 03:01:51 |
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Basic information
Public title
Association Between Acceptance of Disability and Psychosocial Factors in Patients With Stroke During Convalescent Rehabilitation
Acronym
Association Between Acceptance of Disability and Psychosocial Factors in Patients With Stroke During Convalescent Rehabilitation
Scientific Title
Association Between Acceptance of Disability and Psychosocial Factors in Patients With Stroke During Convalescent Rehabilitation
Scientific Title:Acronym
Association Between Acceptance of Disability and Psychosocial Factors in Patients With Stroke During Convalescent Rehabilitation
Region
| Japan |
Condition
Condition
STROKE
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective of this study is to investigate the cross-sectional association between disability acceptance and psychosocial factors within one week after admission among patients with stroke admitted to a convalescent rehabilitation ward. The secondary objective is to examine longitudinal changes in disability acceptance at 30 and 60 days after admission and to explore their associations with psychosocial factors, physical function, and activities of daily living (ADL).
Basic objectives2
Others
Basic objectives -Others
A prospective observational study investigating the association between disability acceptance and psychosocial factors in patients with stroke during convalescent rehabilitation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Total score of the Acceptance of Illness Scale (AIS) assessed within one week after admission.
Key secondary outcomes
Total scores of the Acceptance of Illness Scale (AIS) at 30 and 60 days after admission and changes in AIS total scores between assessment time points. Brunnstrom Recovery Stage (BRS), Short Physical Performance Battery (SPPB), Functional Independence Measure (FIM), Multidimensional Health Locus of Control Form C (MHLC Form C) subscale scores, and the Japanese short version of the Multidimensional Scale of Perceived Social Support (MSPSS), assessed within one week, at 30 days, and at 60 days after admission, as well as their longitudinal changes.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients aged 65 years or older.
2.Patients with ischemic stroke or intracerebral hemorrhage who are admitted to a convalescent rehabilitation ward.
3.Patients who are able to understand the questionnaire items and respond independently.
4.Patients who have provided written informed consent after receiving sufficient explanation of the study.
Key exclusion criteria
1.Patients with severe cognitive impairment that makes it difficult to understand the study or complete the questionnaires.
2.Patients with aphasia or higher brain dysfunction that interferes with completion of the questionnaires required for the study.
3.Patients with impaired consciousness.
4.Patients who are considered unable to participate in the study due to the influence of psychiatric disorders.
5.Patients who do not provide consent to participate in the study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ryohei |
| Middle name | |
| Last name | Yamada |
Organization
Kio University
Division name
Graduate School of Health Sciences
Zip code
635-0832
Address
4-2-2 Umami-naka, Koryo-cho, Kitakatsuragi-gun, Nara 635-0832, Japan
TEL
0745-54-1601
f6944636@kio.ac.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Yamada |
Organization
Medical Corporation Kyowakai, Senri Chuo Hospital
Division name
Department of Rehabilitation
Zip code
560-0082
Address
1-4-3 Shinsenri-Higashimachi, Toyonaka, Osaka 560-0082, Japan
TEL
06-6834-1100
Homepage URL
f6944636@kio.ac.jp
Sponsor or person
Institute
Kio University
Institute
Department
Personal name
Ryohei Yamada
Funding Source
Organization
Kio University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Senri Chuo Hospital
Address
1-4-3 Shinsenri-Higashimachi, Toyonaka, Osaka 560-0082, Japan
Tel
06-6834-1100
f6944636@kio.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
千里中央病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 08 | 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
| 2026 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 23 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a single-center prospective observational study involving patients with stroke admitted to a convalescent rehabilitation ward. Potential participants will be identified based on admission information and medical records at the convalescent rehabilitation ward of Senri Chuo Hospital, and patients who meet the inclusion and exclusion criteria will be invited to participate. The recruitment period is planned from October 1, 2026 to July 31, 2027. The primary analysis will be a cross-sectional analysis of assessments conducted within one week after admission to investigate the association between disability acceptance and psychosocial factors. As secondary analyses, repeated assessments will be conducted at 30 and 60 days after admission to explore longitudinal changes in disability acceptance and their associations with psychosocial factors, physical function, and activities of daily living (ADL). No study-specific intervention will be performed.
Management information
Registered date
| 2026 | Year | 09 | Month | 08 | Day |
Last modified on
| 2026 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071940
