UMIN-ICDS Clinical Trial

Unique ID issued by UMIN	UMIN000062404
Receipt number	R000071033
Scientific Title	Development and Evaluation of a "Three-Layer Governance" Implementation Strategy to Overcome Workforce Juniorization Risk in Subacute Rehabilitation Organizations: A Multicenter Prospective-Retrospective Hybrid Cohort Study
Date of disclosure of the study information	2026/07/30
Last modified on	2026/07/30 13:44:58

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Basic information

Public title

Development and Evaluation of a "Three-Layer Governance" Implementation Strategy to Overcome Workforce Juniorization Risk in Subacute Rehabilitation Organizations: A Multicenter Prospective-Retrospective Hybrid Cohort Study

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

All conditions for which patients may be admitted to the post-acute rehabilitation ward

Classification by specialty

Neurology Orthopedics Neurosurgery

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To overcome the organizational risks associated with the trend towards younger staff in convalescent rehabilitation wards, we will develop a 'three-tier governance' model that integrates AI-powered movement analysis training (Hard), organizational coordination (Soft), and the fostering of psychological safety (Heart). The aim of this study is to verify, using a multi-centre difference-in-differences (DiD) analysis, the effects of this model on the standardization of therapists' skills, the reduction of staff's physical and mental workload, improvements in ward performance indicators (FIM gain and reduction in length of stay), and the reduction of staff turnover.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Improvement in rehabilitation facility performance indicators (including Functional Independence Measure (FIM) gain and length of stay)

Key secondary outcomes

Changes in staff years of experience
Staff turnover rate (annual retention rate)

Base

Study type

Interventional

Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Institution is considered as a block.

Blocking

YES

Concealment

No need to know

Intervention

No. of arms

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment Behavior,custom

Interventions/Control_1

[Intervention Group: Hanabatake Hospital]
Duration: Continuous implementation for 12 months starting July 2026.
Content: Introduction of a 'three-tier governance' model.
1. Hard (As needed): Transfer technique feedback using AI video analysis (VP-Ergono) and introduction of KAFO clinical protocols.
2. Soft (Weekly): Integration of clinical reminders into existing weekly brace rounds for organizational coordination.
3. Heart (Weekly): Weekly leader-staff interviews to monitor mental workload and foster psychological safety.

Interventions/Control_2

[Control Group: Sakurajuji Fukuoka Hospital, Sakurajuji Otemon Hospital, and Sakurajuji Shirokane Rehabilitation Hospital]
Duration: 12 months.
Content: Continuation of conventional education and management systems without the implementation of the three-tier governance model. Note: Sakurajuji Shirokane Rehabilitation Hospital will serve as a complete control group for the initial 12 months, after which it will cross over to the intervention group based on a stepped-wedge design.

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

The subjects of this study must meet the following criteria:
1. Patient data: All patients admitted to the convalescent rehabilitation wards of the target facilities and billed for rehabilitation fees during the study period.
2. Staff data: All staff members (e.g., physical therapists, occupational therapists, speech-language-hearing therapists) engaged in clinical practice in the rehabilitation departments of the target facilities during the study period.

Key exclusion criteria

The exclusion criteria are as follows:
1. Data with clear missing values in key metrics required for evaluation (e.g., admission and discharge FIM scores, length of stay, staff experience years).
2. Patient data of those who could not complete the convalescent rehabilitation program due to death, acute exacerbation, or transfer to another ward/hospital.
3. Patients or staff members who explicitly opted out of having their data used for research purposes.

Target sample size

500

Research contact person

Name of lead principal investigator

1st name Daichi

Middle name

Last name Yoshida

Organization

Fukuoka Sakurajuji Medical Corporation Hanabatake Hospital / Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)

Division name

Rehabilitation Department

Zip code

838-0214

Address

914 Nishimachi, Kurume City, Fukuoka Prefecture

TEL

09092057660

Email

mugonjikkou@yahoo.co.jp

Public contact

Name of contact person

1st name daichi

Middle name

Last name yoshida

Organization

Fukuoka Sakurajuji Medical Corporation Hanabatake Hospital

Division name

Rehabilitation Department

Zip code

838-0214

Address

914 Nishimachi, Kurume City, Fukuoka Prefecture

TEL

09092057660

Homepage URL

Email

mugonjikkou@yahoo.co.jp

Sponsor or person

Institute

Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)

Institute

Department

Personal name

daichi yoshida

Funding Source

Organization

Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Other related organizations

Co-sponsor

Kwansei Gakuin University

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)

Address

5-11 Watanabe-dori 3-chome, Chuo Ward, Fukuoka City

Tel

092-791-1100

Email

mugonjikkou@yahoo.co.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2026 Year 07 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

Open public recruiting

Date of protocol fixation

2026 Year 06 Month 27 Day

Date of IRB

2026 Year 06 Month 29 Day

Anticipated trial start date

2026 Year 07 Month 01 Day

Last follow-up date

2029 Year 06 Month 30 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 07 Month 30 Day

Last modified on

2026 Year 07 Month 30 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071033