UMIN-CTR Clinical Trial

Public title

A Study of the Relationship Between the Timing of Mobilization and Safety and Recovery in Patients with Acute Aneurysmal Subarachnoid Hemorrhage

Acronym

Mobilization in aSAH Study

Scientific Title

Impact of Mobilization Timing on Safety and Effectiveness in Patients with Acute Aneurysmal Subarachnoid Hemorrhage: A Target Trial Emulation Study

Scientific Title:Acronym

Impact of Mobilization Timing on Safety and Effectiveness in Patients with Acute Aneurysmal Subarachnoid Hemorrhage

Region

Japan

Condition

Acute Aneurysmal Subarachnoid Hemorrhage

Classification by specialty

Neurology	Neurosurgery	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The aim of this study is to investigate the impact of the timing of mobilization by nurses, physical therapists, occupational therapists, and speech-language pathologists on safety (cerebral infarction associated with cerebral vasospasm) and effectiveness (complications, activities of daily living, discharge destination, length of hospital stay, physical function, and cognitive function) in patients with acute aneurysmal subarachnoid hemorrhage.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Occurrence and onset date of delayed cerebral infarction associated with cerebral vasospasm

Key secondary outcomes

Occurrence and onset date of postoperative complications
Activities of daily living (ADL) at discharge assessed by the Barthel Index and Nursing care needs assessment category B: turning over in bed
Discharge destination
Length of hospital stay
Brunnstrom Recovery Stage
Japanese Nursing Care Needs Assessment B items ability to understand medical and nursing instructions and presence of unsafe behaviors

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients meeting all of the following criteria were included:
1. Adults aged 18 years or older with aneurysmal subarachnoid hemorrhage (SAH) within 3 days of rupture.
2. Patients who underwent surgical treatment.
3. Patients with Hunt and Hess grades I to III, representing mild to moderate severity of SAH.

Key exclusion criteria

Patients meeting any of the following criteria were excluded:
Required assistance with activities of daily living before admission (pre-stroke modified Rankin Scale [mRS] score >= 4).
Developed aneurysmal subarachnoid hemorrhage during hospitalization.
Had contraindications to rehabilitation.
Had severe respiratory or cardiovascular disease at admission.
Had concomitant lower extremity fractures.

Target sample size

300

Name of lead principal investigator

1st name	Tatsuya
Middle name
Last name	Iwasaki

Organization

Akiyama Neurosurgical Hospital

Division name

Department of Rehabilitation

Zip code

233-0012

Address

2-10-36, Kaminagaya, Yokohama, Kanagawa,Japan

TEL

0458461001

Email

62514501.xrx@kuhs.ac.jp

Name of contact person

1st name	Tatsuya
Middle name
Last name	Iwasaki

Organization

Akiyama Neurosurgical Hospital

Division name

Department of Rehabilitation

Zip code

233-0012

Address

2-10-36, Kaminagaya, Yokohama, Kanagawa,Japan

TEL

0458461001

Homepage URL

Email

62514501.xrx@kuhs.ac.jp

Institute

Kanagawa University of Human Services

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science(JSPS)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Kanagawa University of Human Services

Address

Kanagawa University of Human Services

Tel

046-828-2530

Email

kenkyuurinri@kuhs.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

11

Month

05

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

Preinitiation

Date of protocol fixation

2026

Year

11

Month

30

Day

Date of IRB

2026

Year

10

Month

29

Day

Anticipated trial start date

2026

Year

12

Month

01

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

[Exposure]
As this was a retrospective observational study, the exposure was defined as the timing of mobilization initiation. The operational definition of initial mobilization was as follows: initial mobilization was defined as the first performance of any of the following activities: sitting on the edge of the bed, standing, wheelchair transfer, or walking, performed with the involvement of a nurse, physical therapist, occupational therapist, or speech-language-hearing therapist. The requirement for assistance was not considered. Mobilization was considered to have occurred when it was performed at least once per day.
The date of mobilization initiation was defined as the day on which mobilization was first performed, with the day of disease onset designated as day 0.
Patients were classified into two treatment strategies:
Early mobilization strategy: initiation of mobilization within 7 days after onset.
Delayed mobilization strategy: no initiation of mobilization within 7 days after onset.

[Overview of Statistical Analysis]
Propensity scores were estimated using baseline confounders identified based on a directed acyclic graph (DAG). Inverse probability of treatment weighting (IPTW) was applied using the estimated propensity scores to balance baseline confounders between the two strategies. Outcomes were compared using weighted regression models adjusted for the prespecified confounding factors.
Sensitivity analyses were conducted by modifying the definition of the mobilization initiation window. In addition, competing risk analysis accounting for death as a competing event was performed to assess the robustness of the primary findings.

Registered date

2026

Year

06

Month

14

Day

Last modified on

2026

Year

11

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070825