UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000063553
Receipt number R000072727
Scientific Title Comparison of TUG Completion Times and Discriminative Ability for Gait Independence Between Turning Directions in Patients With Subacute Stroke
Date of disclosure of the study information 2026/11/06
Last modified on 2026/11/06 23:02:51

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Basic information

Public title

A Study Comparing Test Completion Times and the Ability to Identify Independent Walking Between Turning Directions in Patients Recovering From Stroke Before Hospital Discharge

Acronym

Stroke Turning and Walking Independence Study

Scientific Title

Comparison of TUG Completion Times and Discriminative Ability for Gait Independence Between Turning Directions in Patients With Subacute Stroke

Scientific Title:Acronym

Stroke TUG Turning-Direction Study

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Neurology Neurosurgery Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study was to examine differences in Timed Up and Go (TUG) completion times between turning directions and determine whether these differences vary according to gait independence in patients with subacute stroke.

Basic objectives2

Others

Basic objectives -Others

The objective of this study was to compare the ability of the Timed Up and Go (TUG) test performed in each turning direction to discriminate between independent and non-independent walking in patients with subacute stroke.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Timed Up and Go Test

Key secondary outcomes

10-m Walk test, Fugl-Meyer Assessment, Functional Independence Measure, Mini-Mental State Examination, Functional ambulation categories


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with first-ever ischemic stroke or intracerebral hemorrhage who were admitted to a convalescent rehabilitation ward between January 2024 and May 2026.
2. Patients with medical records containing Timed Up and Go Test (TUG) results for both affected- and unaffected-side turning and Functional Ambulation Categories (FAC) scores assessed within 30 days before discharge.

Key exclusion criteria

1. Patients with subarachnoid hemorrhage.
2. Patients with bilateral or cerebellar lesions.
3. Patients with difficulty walking.
4. Patients with difficulty understanding verbal instructions.
5. Patients with a Mini-Mental State Examination (MMSE) score below 20.
6. Patients with missing data required for the analysis.

Target sample size

150


Research contact person

Name of lead principal investigator

1st name Takayuki
Middle name
Last name Maru

Organization

Ishikawa Hospital

Division name

Department of Rehabilitation

Zip code

671-0021

Address

2-150 Bessho, Bessho-cho, Himeji, Hyogo

TEL

079-252-5235

Email

puyaji1204@gmail.com


Public contact

Name of contact person

1st name Takayuki
Middle name
Last name Maru

Organization

Ishikawa Hospital

Division name

Department of Rehabilitation

Zip code

671-0021

Address

2-150 Bessho, Bessho-cho, Himeji, Hyogo

TEL

079-252-5235

Homepage URL


Email

puyaji1204@gmail.com


Sponsor or person

Institute

other

Institute

Department

Personal name



Funding Source

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ishikawa Hospital

Address

2-150 Bessho, Bessho-cho, Himeji, Hyogo

Tel

079-252-5235

Email

puyaji1204@gmail.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

石川病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2026 Year 11 Month 06 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

147

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

Completed

Date of protocol fixation

2025 Year 01 Month 01 Day

Date of IRB

2025 Year 10 Month 14 Day

Anticipated trial start date

2025 Year 10 Month 14 Day

Last follow-up date

2026 Year 05 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

This was a single-center, retrospective cross-sectional study. Medical records of patients with first-time stroke admitted to a convalescent rehabilitation ward between January 2024 and May 2026 were retrospectively reviewed. A total of 120 patients were included in the analysis based on the eligibility criteria. TUG completion times with turning toward the affected and unaffected sides, measured within 30 days before discharge, were compared, and their associations with gait independence assessed using the Functional Ambulation Categories (FAC) were examined. Receiver operating characteristic (ROC) analysis was also performed to compare the ability of TUG in each turning direction to discriminate gait independence.


Management information

Registered date

2026 Year 11 Month 06 Day

Last modified on

2026 Year 11 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072727