UMIN-ICDS Clinical Trial

Public title

A Study to Evaluate the Effects of the Rehabilitation Goal-Setting Support System (e-ASUHS) in Patients With Acute Stroke

Acronym

e-ASUHS Effect Study in Acute Stroke

Scientific Title

Effects of an e-ASUHS Based Intervention in Patients With Acute Stroke: A Multiple Baseline Single Case Design Study

Scientific Title:Acronym

e-ASUHS Effect Study in Acute Stroke

Region

Japan

Condition

Stroke

Classification by specialty

Neurology	Neurosurgery	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to examine the effects of an intervention using the electronic version of the Activities Specific Upper-Extremity Hemiparesis Scale (e-ASUHS) on depressive symptoms, quality of life (QOL), and upper-extremity function in patients with acute stroke.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Outcomes were generally assessed after each intervention session by the principal investigator or by the participant.

Transient depressive mood was assessed using a patient self rated measure Bui et al. 2024. Assessments were conducted between 2:00 p.m. and 4:00 p.m. At each assessment participants were asked using identical written materials and standardized verbal instructions "We would like to ask you about your current mood. Are you feeling depressed right now." Responses were rated on a 5 point scale 1 not at all 2 slightly 3 moderately 4 considerably 5 extremely depressed and participants were instructed to select the single response that best reflected their current state. This measure was used to monitor within participant fluctuations in depressive mood over time.

Key secondary outcomes

Perceived usefulness was assessed using a patient self rated measure Matsuoka et al. 2025. This measure evaluates the subjective usefulness of the paretic upper extremity using a visual analogue scale VAS. Participants were asked "To what extent do you feel that your affected hand is useful" and responded by marking a point on a VAS ranging from 0 not useful at all to 100 extremely useful.

Health related quality of life QOL was assessed using the EQ 5D 5L a self administered instrument consisting of five items and requiring approximately 5 minutes to complete. The EQ 5D 5L evaluates five domains mobility self care usual activities pain or discomfort and anxiety or depression based on patient self report. The index score ranges from 0 worst health state to 1 full health.

Upper extremity motor function was assessed using the Fugl Meyer Assessment for the Upper Extremity FMA UE. The FMA UE evaluates motor function of the upper limb wrist and hand as well as reflex activity and coordination with a maximum score of 66 points where higher scores indicate better motor function. The FMA UE has been reported to be an optimal measure for assessing upper extremity function in patients with stroke de Blas Zamorano et al. 2025.

The Motor Activity Log MAL was used as a patient self rated outcome measure. The MAL is a semi structured interview that assesses the amount of use and quality of movement of the paretic upper extremity during activities of daily living based on the patient self perception Lang et al. 2008.

Study type

Interventional

Basic design

n-of-1

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Other

Interventions/Control_1

To enhance external validity and generalizability, the data collection period was set to 14 days, during which a baseline phase (A phase) and an intervention phase (B phase) were allocated based on the average length of stay for acute stroke in Japan (ischemic stroke 16 days, intracerebral hemorrhage 20 days, Stroke Data Bank 2025). Both phases lasted at least 2 days (Fujimaki et al. 2022). The intervention was provided once daily, 5 days per week, for 40 to 60 minutes per session by the principal investigator.

A multiple baseline single case design with randomized phase allocation was used. Following Fujimaki et al. (2022), three baseline patterns were applied across participants: 1 AAAABBBBBBBBBB, 2 AAAAAAAABBBBBB, 3 AAAAABBBBBBBBB.

During the baseline phase (A phase), goal setting based on Omori et al. (2018) and task oriented training described by Geller et al. (2023) were implemented. Task oriented training involved repetitive practice of functional tasks to improve activities of daily living (ADL) and upper extremity function.

During the intervention phase (B phase), procedures followed Matsuoka et al. (2021). The electronic version of the Activities Specific Upper extremity Hemiparesis Scale (e ASUHS) is an Excel based goal setting support system that facilitates selection of ADL tasks according to upper extremity function (Matsuoka et al. 2023). Participant information and upper extremity function including the Fugl Meyer Assessment for the Upper Extremity (FMA UE) were entered, achievable tasks were automatically highlighted to support shared decision making, task oriented training was conducted, and progress was monitored using a checklist.

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

Age-lower limit

18

years-old

<=

Age-upper limit

100

years-old

>=

Gender

Male and Female

Key inclusion criteria

Participants were required to meet all of the following inclusion criteria.

1 Patients diagnosed with stroke at Akiyama Neurosurgical Hospital.

2 Within 1 month of stroke onset YS An CS et al. 2021.

3 Aged 18 years or older regardless of sex.

4 Presence of upper extremity paresis.

5 Presence of depressive symptoms defined as a Patient Health Questionnaire 9 PHQ 9 score of 5 or higher.

Key exclusion criteria

Participants were excluded if they met any of the following criteria.

Difficulty following instructed tasks due to cognitive impairment higher brain dysfunction or impaired consciousness.

Inability to maintain a sitting position for 30 minutes or longer including wheelchair sitting.

Presence of severe pain in the upper extremity.

Inability to make clear decisions.

Unknown date of stroke onset.

No history of psychiatric disorders.

Target sample size

3

Name of lead principal investigator

1st name	Tatsuya
Middle name
Last name	Iwasaki

Organization

Akiyama Neurosurgical Hospital

Division name

Department of Rehabilitation

Zip code

2330012

Address

2-10-36, Kaminagaya, Konan ward, Yokohama city, Kanagawa prefecture,Japan

TEL

0458461001

Email

tatsuyaiwa0130@yahoo.co.jp

Name of contact person

1st name	Tatsuya
Middle name
Last name	Iwasaki

Organization

Akiyama Neurosurgical Hospital

Division name

Department of Rehabilitation

Zip code

2330012

Address

2-10-36, Kaminagaya, Konan ward, Yokohama city, Kanagawa prefecture,Japan

TEL

0458461001

Homepage URL

Email

tatsuyaiwa0130@yahoo.co.jp

Institute

Akiyama Neurosurgical Hospital

Institute

Department

Personal name

Tatsuya Iwasaki

Organization

Akiyama Neurosurgical Hospital

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Akiyama Neurosurgical Hospital

Address

2-10-36, Kaminagaya, Konan ward, Yokohama city, Kanagawa prefecture,Japan

Tel

0458461001

Email

tatsuyaiwa0130@yahoo.co.jp

Secondary IDs

YES

Study ID_1

2026-1

Org. issuing International ID_1

Akiyama Neurosurgical Hospital

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

02

Month

12

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2026

Year

02

Month

08

Day

Date of IRB

2026

Year

02

Month

12

Day

Anticipated trial start date

2026

Year

02

Month

13

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

01

Month

23

Day

Last modified on

2026

Year

02

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069171