UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062068 |
|---|---|
| Receipt number | R000058286 |
| Scientific Title | Development of a new system (e-ASUHS) to support the setting of goals for daily activities performed with the affected upper extremity after stroke |
| Date of disclosure of the study information | 2026/06/26 |
| Last modified on | 2026/06/26 15:26:57 |
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Basic information
Public title
Development of a new system (e-ASUHS) to support the setting of goals for daily activities performed with the affected upper extremity after stroke
Acronym
Development of a goal setting support system (e-ASUHS)
Scientific Title
Development of a new system (e-ASUHS) to support the setting of goals for daily activities performed with the affected upper extremity after stroke
Scientific Title:Acronym
Development of a goal setting support system (e-ASUHS)
Region
| Japan |
Condition
Condition
stroke
Classification by specialty
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aims of this study are to provide information necessary for shared decision-making with patients regarding the paretic upper extremity in stroke rehabilitation, to develop a prediction model generalizable across multiple centers using the goal-setting support system e-ASUHS, and to investigate the association between an intervention that facilitates shared decision-making and psychological outcomes. Ultimately, this study seeks to contribute to occupational therapy practice that incorporates shared decision-making for patients with stroke and to enhance their quality of life (QOL).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Upper extremity function, depressive symptoms, quality of life (QOL), and the ability to perform activities of daily living with the paretic upper extremity will be assessed at multiple time points according to the rehabilitation setting. In the acute phase, assessments will be conducted at the initiation of occupational therapy, 1 week after initiation, and at discharge. In the convalescent phase, assessments will be conducted at admission, 1 month after admission, at discharge, and 1 month after discharge. In home-based, day-care, and outpatient rehabilitation settings, assessments will be conducted at the initiation of e-ASUHS, 1 month after initiation, and 6 months after initiation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
e-ASUHS group:
e-ASUHS will be introduced to patients with a wide range of paretic upper extremity function. Participants who consent to receive rehabilitation using e-ASUHS will undergo an e-ASUHS-based intervention, while the remainder of their rehabilitation will be the same as that provided to the control group. In the acute phase, goal setting using e-ASUHS will be conducted once a week, whereas in the convalescent, home-visit, day-care, and outpatient rehabilitation settings, it will be conducted once a month. Participants will also be encouraged to practice the daily activities selected as goals in their everyday lives.
The intervention period will be from admission to discharge in the acute and convalescent rehabilitation settings, and 6 months in the home-visit, day-care, and outpatient rehabilitation settings.
Interventions/Control_2
Control group:
Participants will be assigned to the control group if consent to use e-ASUHS is not obtained, or if the occupational therapist judges that the use of e-ASUHS would be difficult in consideration of the therapeutic relationship with the participant. The control group will receive usual rehabilitation.
The intervention period will be from admission to discharge in the acute and convalescent rehabilitation settings, and 6 months in the home-visit, day-care, and outpatient rehabilitation settings.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria were as follows: (1) patients with upper extremity hemiparesis due to a first-ever cerebral infarction or intracerebral hemorrhage, and (2) patients who provided written informed consent to participate in this study.
Key exclusion criteria
The exclusion criteria were as follows: (1) severe cognitive impairment that made it difficult to follow instructions; (2) inability to maintain a sitting position for more than 30 minutes; (3) severe upper extremity pain; and (4) inability to make decisions clearly regarding participation in the study.
Target sample size
660
Research contact person
Name of lead principal investigator
| 1st name | Aki |
| Middle name | |
| Last name | Watanabe |
Organization
Kanagawa University of Human Services
Division name
Department of Rehabilitation
Zip code
238-8522
Address
1-10-1 Heiseicho, Yokosuka-shi, Kanagawa, Japan
TEL
046-828-2500
akiwat.323@gmail.com
Public contact
Name of contact person
| 1st name | Aki |
| Middle name | |
| Last name | Watanabe |
Organization
Kanagawa University of Human Services
Division name
Department of Rehabilitation
Zip code
238-8522
Address
1-10-1 Heiseicho, Yokosuka-shi, Kanagawa, Japan
TEL
046-828-2500
Homepage URL
akiwat.323@gmail.com
Sponsor or person
Institute
Kanagawa University of Human Services
Institute
Department
Personal name
Aki Watanabe
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
Japanese Association of Occupational Therapist, Pfizer Health Research Foundation
IRB Contact (For public release)
Organization
Kanagawa University of Human Services
Address
1-10-1 Heiseicho, Yokosuka-shi, Kanagawa, Japan
Tel
046-828-2500
akiwat.323@gmail.com
Secondary IDs
Secondary IDs
YES
Study ID_1
Approval No. 182312
Org. issuing International ID_1
Kanagawa University of Human Services
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
神奈川県立保健福祉大学（神奈川県）、国立精神・神経医療研究センター精神保健研究所（東京都）、多摩丘陵リハビリテーション病院（東京都）、琵琶湖中央リハビリテーション病院（滋賀県）、秋山脳神経外科病院（神奈川県）、善常会リハビリテーション病院（愛知県）、手稲渓仁会病院（北海道）、函館病院（北海道）、釧路孝仁会リハビリテーション病院（北海道）、聖隷横浜病院（神奈川県）、九段坂病院（東京都）、川崎協同病院（神奈川県）、奈良セントラル病院（奈良県）、群馬リハビリテーション病院（群馬県）、横浜新緑総合病院（神奈川県）、小波瀬病院（福岡県）、旭川リハビリテーション病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 26 | 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 | 09 | Month | 11 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2026 | Year | 06 | Month | 26 | Day |
Last modified on
| 2026 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058286
