UMIN-ICDS Clinical Trial

Public title

Development of a Prognostic Prediction System for Walking Independence in Patients with Subacute Stroke

Acronym

Development of a Prognostic Prediction System for Walking Independence in Patients with Subacute Stroke

Scientific Title

Development of a Prognostic Prediction System for Walking Independence in Patients with Subacute Stroke

Scientific Title:Acronym

Development of a Prognostic Prediction System for Walking Independence in Patients with Subacute Stroke

Region

Japan

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Re-acquisition of gait is one of the main goals of physical therapy in stroke patients. Many stroke patients in the convalescent unit require therapeutic intervention to regain ambulation and social reintegration even after physical therapy in the acute care ward is completed. However, there have been no prospective studies that have comprehensively incorporated factors that affect walking independence at the time of admission to a convalescent unit. Factors that affect walking independence include not only physical function, but also cognitive function, higher brain dysfunction, and the presence or absence of voiding disorders. Therefore, it is necessary to develop a clinical prediction equation created with all of these factors as predictors.
In addition, most of the past prognostic studies on walking independence have defined walking independence as independence in level walking, and have not predicted important outcomes in returning to social life, such as outdoor walking and stair climbing.
It is very important to clarify the level of walking independence during the period after stroke onset in order to set treatment goals, adjust the post-discharge environment, and determine the duration of inpatient treatment.
Therefore, the purpose of this study is to predict the level of ambulatory independence for patients who are not independent in walking outdoors at the time of admission to the rehabilitation ward, by period of time after admission to the convalescent unit.

Basic objectives2

Others

Basic objectives -Others

The purpose of this study is to predict the level of ambulatory independence for patients who are not independent in walking outdoors at the time of admission to the rehabilitation ward, by period of time after admission to the convalescent unit.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

During hospitalization, patients will be assessed for ambulation independence every 2 weeks from onset using the Functional Ambulation Categories. For patients who are not able to walk outdoors independently at discharge, FAC will be assessed every 4 weeks from onset after discharge. The study period will be up to 24 weeks after onset. Once the patient is ambulatory, the gait independence survey will be terminated.

Key secondary outcomes

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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Patients with a stroke (cerebral infarction/cerebral hemorrhage) who have been admitted to a convalescent unit and have undergone physical therapy.
(2) Age over 20 years old.

Key exclusion criteria

(1) Patients who had difficulty in walking alone before the stroke.
(2) Those who have difficulty in understanding instructions.
(3) Patients for whom the physician or physiotherapist judged that it is dangerous to evaluate at the time of admission to the unit.
(4) Patients who were able to walk outdoors independently within one week of admission to the convalescent unit.

Target sample size

140

Name of lead principal investigator

1st name	Shuntaro
Middle name
Last name	Tamura

Organization

Fujioka General Hospital

Division name

Department of Rehabilitation

Zip code

375-8503

Address

813-1, nakakurisu, fujioka, gunma, Japan

TEL

0274223311

Email

m12204013@gunma-u.ac.jp

Name of contact person

1st name	Shuntaro
Middle name
Last name	Tamura

Organization

Fujioka General Hospital

Division name

Department of Rehabilitation

Zip code

375-0015

Address

813-1, nakakurisu, fujioka, gunma, Japan

TEL

0274223311

Homepage URL

Email

m12204013@gunma-u.ac.jp

Institute

Fujioka General Hospital

Institute

Department

Personal name

Shuntaro Tamura

Organization

self-procurement

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Fujioka General Hospital

Address

813-1, nakakurisu, fujioka, gunma, Japan

Tel

0274223311

Email

m12204013@gunma-u.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

2023

Year

04

Month

01

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

Enrolling by invitation

Date of protocol fixation

2023

Year

01

Month

15

Day

Date of IRB

2023

Year

02

Month

22

Day

Anticipated trial start date

2023

Year

04

Month

01

Day

Last follow-up date

2024

Year

10

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Research procedure
In this study, basic information will be collected from patients with stroke admitted to a convalescent unit and assessed at the time of admission within one week.

0 Basic information.
(1) Age, (2) gender, (3) medical history, (4) number of days since onset, (5) Body Mass Index, (6) level of walking independence before onset (Functional Ambulation Categories; FAC).

Assessment at the time of admission
(1) Knee extension muscle strength on the paralysed side
(2) Berg Balance Scale (BBS)
(3) Mini-Mental State Examination (MMSE)
(4) Hemispatial neglect (Linear bisection test)
(5) Functional Independence Measure (FIM)

Thereafter, walking independence is assessed by FAC every two weeks from onset during hospitalisation. For patients who are not able to walk outdoors independently at discharge, the FAC is also assessed every four weeks from onset after discharge. The study period is limited to a maximum of 24 weeks from onset. For subjects who have achieved independent outdoor ambulation, the gait independence survey will be terminated at that point.
The assessment of FAC during hospitalisation is determined from interviews with rehabilitation staff, nurses and doctors other than the subject's physiotherapist, and from records. Post-discharge assessments are made by interviewing the subject or family members by telephone or mail to assess the implementation of the gait. If the subject is admitted to a facility, a document is attached to the information form at the time of admission to the facility to inform the subject in advance of participation in the study and the post-discharge survey, and the assessment is made by interviewing the facility staff by telephone or by post about the progress of the subject's gait.

Registered date

2023

Year

03

Month

18

Day

Last modified on

2024

Year

03

Month

18

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057609