UMIN-CTR Clinical Trial

Public title

Minimal clinically important change in the assessment of lower limb motor function in people with acute stroke.

Acronym

MIC-FMALE in patients with stroke

Scientific Title

The minimal clinically important change of the Fugl-Meyer Assessment lower extremity motor scale in patients with acute stroke.

Scientific Title:Acronym

The MIC in FMA lower extremity motor score in patients with acute stroke

Region

Japan

Condition

stroke

Classification by specialty

Neurology	Neurosurgery	Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To investigate the Minimal Clinically Important Change in the Fugl-Meyer Assessment lower extremity motor scale in patients with acute stroke.

Basic objectives2

Others

Basic objectives -Others

To investigate the cut-off points of the Fugl-Meyer Assessment lower extremity motor scale for clinically important values of other standardized assessment tools.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Fugl-Meyer Assessment Lower Extremity Motor Scale
Global rating scale of change (Patient perspective)
Global rating scale of change (Therapist perspective)

Key secondary outcomes

Short Physical Performance Battery
Functional Ambulation Categories
Trunk Control Test
Timed Up and Go test
Functional Independence Measure
Five sit to stand test

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

stroke (cerebral hemorrhage or cerebral infarction)

Key exclusion criteria

(1) Patients who have difficulty understanding instructions due to severe disturbance of consciousness
(2) Patients with a history of mental illness or severe cognitive decline
(3) Patients who have difficulty understanding instructions due to severe aphasia
(4) Patients with a history of locomotor or internal disorders that limit activities of daily living (ADL)
(5) Patients who did not give their consent
(6) Patients with FMA-LE motor score of 30 or higher at baseline

Target sample size

100

Name of lead principal investigator

1st name	Tetsuharu
Middle name
Last name	Nakazono

Organization

Kiatasato University Hospital

Division name

Department of Rehabilitation

Zip code

252-0375

Address

1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan

TEL

0427788413

Email

ptnaka@kitasato-u.ac.jp

Name of contact person

1st name	Tetsuharu
Middle name
Last name	Nakazono

Organization

KItasato University Hospital

Division name

Department of Rehabilitation

Zip code

252-0375

Address

1-15-1, Kitasato, Minami-ku, Sagamihara-city, Japan

TEL

0427788413

Homepage URL

Email

ptnaka@kitasato-u.ac.jp

Institute

Kitasato University Hospital

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

KItasato University Hospital

Address

1-15-1,Kitasato,Minami-ku,Sagamihara,Japan

Tel

0427788413

Email

ptnaka@kitasato-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

北里大学病院

Date of disclosure of the study information

2023

Year

09

Month

23

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

2023

Year

09

Month

12

Day

Date of IRB

2023

Year

09

Month

27

Day

Anticipated trial start date

2023

Year

09

Month

29

Day

Last follow-up date

2025

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Study design: prospective single-center study

Data collection will start in September 2023. The present study includes a sample of convenience of patients hospitalized at the departments of rehabilitation in a university hospital in Japan speaking Japanese. Patients fulfilling inclusion criteria who agreed to participate will be included. The Fugl-Meyer assessment, Global rating scale of change (GRC), Short physical performance battery, Functional ambulation categories, Trunk control test, Functional independence measure Timed up and go test are employed.

Statistical analysis: The Receiver Operating Characteristic (ROC) curve will be used as a splitter to divide the participants into two groups: participants who present changes and participants who do not present changes in the FMA-LE scores based on the average on the GRC (patients and their therapist) which classified to be two groups of GRC < 6 or GRC > 5. The optimal MCID will be determined by the Youden index.

Sample size estimation: The COSMIN recommendation was the basis of the sample size estimation in this study. A sample size of 100 patients evaluated as "very good" was considered the minimum required sample size.

Registered date

2023

Year

09

Month

23

Day

Last modified on

2024

Year

11

Month

25

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059285