UMIN-ICDS Clinical Trial

Unique ID issued by UMIN	UMIN000061859
Receipt number	R000070516
Scientific Title	Development of a Prediction Model for Recovery of Upper Limb Motor Function in Patients with Stroke in the Subacute Phase
Date of disclosure of the study information	2026/06/30
Last modified on	2026/06/10 17:26:29

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Basic information

Public title

Development of a Prediction Model for Recovery of Upper Limb Motor Function in Patients with Stroke in the Subacute Phase

Acronym

Development of a Prediction Model for Recovery of Upper Limb Motor Function in Patients with Stroke in the Subacute Phase

Scientific Title

Development of a Prediction Model for Recovery of Upper Limb Motor Function in Patients with Stroke in the Subacute Phase

Scientific Title:Acronym

Development of a Prediction Model for Recovery of Upper Limb Motor Function in Patients with Stroke in the Subacute Phase

Region

Japan

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

The aim of this study is to develop a prediction model for the severity of upper limb motor impairment at 1, 2, and 3 months after the initial assessment, based on admission data from patients with moderate to severe upper limb motor impairment after stroke in the subacute phase.

Basic objectives2

Others

Basic objectives -Others

Development and validation of a prognostic prediction model for recovery of upper limb motor function in patients with stroke in the subacute phase

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Assessment

Primary outcomes

Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores at 1, 2, and 3 months after the initial assessment.

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) Stroke patients with cerebral infarction or intracerebral hemorrhage whose onset occurred between April 1, 2025 and March 31, 2028.
2) 18 years or older at the initial assessment.
3) Time from stroke onset to the initial assessment between 7 and 56 days.
4) Fugl-Meyer Assessment for Upper Extremity score of 47 or lower at the initial assessment.
5) Continued hospitalization for at least 1 month after the initial assessment.

Key exclusion criteria

1) Subarachnoid hemorrhage.
2) Inability to receive at least 3 units of rehabilitation therapy on 20% or more of hospitalization days.
3) Upper limb pain interfering with rehabilitation for improvement of upper limb motor function.
4) Missing values in three or more predictor variables.
5) Cerebellar ataxia ipsilateral to an infratentorial lesion.
6) Bilateral upper limb motor paresis due to recurrent stroke, making the Thumb Localizing Test difficult to perform.

Target sample size

1000

Research contact person

Name of lead principal investigator

1st name Naoya

Middle name

Last name Anmoto

Organization

Nagoya City University Rehabilitation Hospital

Division name

Division of Occupational Therapy, Department of Rehabilitation Medicine

Zip code

467-8604

Address

1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Aichi, Japan

TEL

052-680-8123

Email

anmoto@med.nagoya-cu.ac.jp

Public contact

Name of contact person

1st name Naoya

Middle name

Last name Anmoto

Organization

Nagoya City University Rehabilitation Hospital

Division name

Division of Occupational Therapy, Department of Rehabilitation Medicine

Zip code

467-8604

Address

1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Aichi, Japan

TEL

052-680-8123

Homepage URL

Email

anmoto@med.nagoya-cu.ac.jp

Sponsor or person

Institute

Nagoya City University Rehabilitation Hospital

Institute

Department

Personal name

Naoya Anmoto

Funding Source

Organization

Japan Science and Technology Agency (JST)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Other related organizations

Co-sponsor

Graduate School of Rehabilitation Science, Osaka Metropolitan University, Osaka, Japan
Department of Rehabilitation, School of Health Sciences, Tokyo University of Technology, Tokyo, Japan

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Nagoya City University Rehabilitation Hospital

Address

1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Aichi, Japan

Tel

052-680-8123

Email

anmoto@med.nagoya-cu.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

社会福祉法人済生会山形済生病院（山形県）
医療法人社団健育会健育会ねりま病院（東京都）
長野県厚生農業協同組合連合会鹿教湯三才山リハビリテーションセンター（長野県）
医療法人えいしん会岸和田リハビリテーション病院（大阪府）
医療法人相生会福岡みらい病院（福岡県）
昭和医科大学　藤が丘リハビリテーション病院（神奈川県）
社会福祉法人農協共済中伊豆リハビリテーションセンター（静岡県）
伊丹恒生脳神経外科病院（兵庫県）
社会医療法人愛生会上飯田リハビリテーション病院（愛知県）
医療法人啓仁会豊川さくら病院（愛知県）
社会福祉法人恩賜財団済生会東神奈川リハビリテーション病院（神奈川県）
医療法人偕行会偕行会リハビリテーション病院（愛知県）
医療法人川崎病院（福岡県）
名古屋市立大学医学部附属みらい光生病院（愛知県）

Other administrative information

Date of disclosure of the study information

2026 Year 06 Month 30 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

2026 Year 04 Month 05 Day

Date of IRB

2026 Year 05 Month 16 Day

Anticipated trial start date

2026 Year 06 Month 01 Day

Last follow-up date

2028 Year 06 Month 30 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

This is a multicenter observational study using clinical data from approximately 1,000 patients with stroke in the subacute phase collected from approximately 15 institutions. Clinical information and assessment measures related to upper limb motor function obtained at the initial assessment during usual care and usual rehabilitation will be used as predictor variables. Fugl-Meyer Assessment for Upper Extremity scores at 1, 2, and 3 months after the initial assessment will be used as outcome variables. Data from 700 patients will be used as the training dataset, and data from 300 patients will be used as the validation dataset. A prognostic prediction model for recovery of upper limb motor function will be developed using decision tree analysis, and its predictive performance will be evaluated using the validation dataset.

Management information

Registered date

2026 Year 06 Month 10 Day

Last modified on

2026 Year 06 Month 10 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070516