UMIN-CTR Clinical Trial

Public title

Effects of AI-based real-time feedback on low back load during patient transfer assistance: a randomized controlled trial

Acronym

AI-Transfer Feedback Trial

Scientific Title

Immediate effects of AI-based real-time feedback of lumbar moment on biomechanical low back load during patient transfer: a randomized controlled trial

Scientific Title:Acronym

AI-Transfer RCT

Region

Japan

Condition

Low back load during patient transfer assistance in healthcare workers (healthy volunteers)

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the immediate effects of AI-based real-time feedback of lumbar moment waveforms, derived from markerless motion analysis (VP-Ergono), in addition to standard transfer instruction and review of participants' own video, on biomechanical low back load (peak lumbar moment and cumulative lumbar load) during patient transfer among healthcare workers who routinely perform transfer assistance. The association between changes in mechanical load and acute subjective burden (pre-to-post changes in pain and fatigue) is also examined. This is a single-session, immediate intervention; effects on chronic low back pain are not evaluated. The direction of change in lumbar load is not prespecified.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Co-primary outcomes (both derived from markerless motion analysis of video; between-group comparison of pre-to-post change): (1) peak lumbar moment (Nm) during patient transfer, and (2) cumulative lumbar load (Nm x s, natural-log transformed). Multiplicity is adjusted by the Bonferroni method (two-sided alpha = 0.025 for each). The direction of change is not prespecified; two-sided tests are used.

Key secondary outcomes

Secondary outcomes: (1) pain VAS/NRS (change from immediately before to immediately after the transfer task), (2) fatigue VAS/NRS (same), (3) median %RVE of the right multifidus (surface EMG, primary interest), (4) median %RVE of the left multifidus (control). Exploratory outcomes: integrated EMG (limited to recordings with adequate electrode contact), rate of change in lumbar moment, right-left asymmetry, and group-by-professional-category and group-by-history-of-low-back-pain interactions (hypothesis-generating).

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Numbered container method

No. of arms

2

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment

Behavior,custom

Interventions/Control_1

In addition to standard transfer instruction, participants review video of their own transfer performance and receive real-time feedback of lumbar moment waveforms derived from markerless motion analysis (VP-Ergono) (single session).

Interventions/Control_2

In addition to standard transfer instruction, participants review video of their own transfer performance without presentation of lumbar moment waveforms (single session). Both groups receive standard instruction and video review, so the between-group difference is limited to the presence or absence of AI feedback (waveform presentation).

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Physical therapists, occupational therapists, speech-language-hearing therapists, nurses, and care workers employed by the medical corporation who provide written informed consent.

Key exclusion criteria

Individuals with severe acute low back pain or neurological symptoms that make it difficult to perform the measurement task; and individuals whom the principal investigator judges to be unsuitable for participation.

Target sample size

60

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

830-0038

Address

914 Nishimachi, Kurume City, Fukuoka Prefecture

TEL

0942-32-4565

Email

mugonjikkou@yahoo.co.jp

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

830-0038

Address

914 Nishimachi, Kurume City, Fukuoka Prefecture

TEL

09092057660

Homepage URL

Email

mugonjikkou@yahoo.co.jp

Institute

Fukuoka Sakurajuji Medical Corporation (Sakurajuji Advanced Rehabilitation Center SACRA)

Institute

Department

Personal name

Daichi Yoshida

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Faculty of Rehabilitation, Nishi Kyushu University

Name of secondary funder(s)

Organization

Institutional Review Board of Sakurajyuji Fukuoka Hospital

Address

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

Tel

092-791-1100

Email

mugonjikkou@yahoo.co.jp

Secondary IDs

YES

Study ID_1

25K13431

Org. issuing International ID_1

Japan Society for the Promotion of Science (JSPS)

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人福岡桜十字　花畑病院（福岡県）

Date of disclosure of the study information

2026

Year

08

Month

10

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

Open public recruiting

Date of protocol fixation

2026

Year

02

Month

17

Day

Date of IRB

2026

Year

02

Month

17

Day

Anticipated trial start date

2026

Year

02

Month

18

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 related information

This trial is registered retrospectively (the first participant was measured on February 18, 2026; UMIN registration occurred thereafter). Thirteen participants had been allocated before UMIN registration; all are included in the trial to preserve the randomness of the allocation sequence. Data from the internal pilot are used only for blinded re-estimation of nuisance parameters (variance and correlation), with no between-group comparison. If the pre-registered allocations are unbalanced, subsequent allocations will be adjusted so that each arm reaches 30 participants (total unchanged). The professional composition is 40 rehabilitation professionals to 20 nursing and care workers (approximately 2:1). Speech-language-hearing therapists are covered by the ethics approval but are excluded from the primary analysis by prespecification because of their low frequency of transfer assistance. Outcome assessment and analysis are performed under blinding using file names that contain no allocation information. The primary analysis is ANCOVA with baseline value, professional category, age, years of experience, BMI, and history of low back pain as covariates.

Registered date

2026

Year

08

Month

10

Day

Last modified on

2026

Year

08

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069425