UMIN-ICDS Clinical Trial

Public title

Perceptual judgment ability of individuals with stroke when avoiding obstacles

Acronym

Perceptual judgment ability of individuals with stroke when avoiding obstacles

Scientific Title

Perceptual judgment ability of individuals with stroke when avoiding obstacles

Scientific Title:Acronym

Perceptual judgment ability of individuals with stroke when avoiding obstacles

Region

Japan

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine whether individuals with stroke can correctly judge whether or not they rotate their bodies when avoiding obstacles (when passing through narrow spaces), use the staircase method, a psychophysical technique.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Relative values of perceptual judgment tasks

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

90

years-old

>

Gender

Male and Female

Key inclusion criteria

The participants had residual hemiparesis. The inclusion criteria were as follows: (a) walking for at least 1 month after a first-time stroke, (b) ability to walk independently >100 m with or without an assistive device and (c) no range of motion restrictions that affected passing behavior such as trunk rotation restrictions.

Key exclusion criteria

The exclusion criteria were as follows: (a) neurological, orthopedic, or other disorders that could affect walking; (b) history of visual deficits; (c) visual field deficits and visual spatial neglect; and (d) score below 24 on the Mini Mental State Examination (MMSE).

Target sample size

20

Name of lead principal investigator

1st name	Daisuke
Middle name
Last name	Muroi

Organization

Chiba Prefectural University of Health and Sciences

Division name

Department of Rehabilitation Sciences, Division of Physical Therapy

Zip code

260-0801

Address

645-1 Nitona-cho, Chiba Chuo-ku, Chiba, 260-0801, Japan.

TEL

043-305-2132

Email

mutyon88@hotmail.com

Name of contact person

1st name	Daisuke
Middle name
Last name	Muroi

Organization

Chiba Prefectural University of Health and Sciences

Division name

Department of Rehabilitation Sciences, Division of Physical Therapy

Zip code

260-0801

Address

645-1 Nitona-cho, Chiba Chuo-ku, Chiba, 260-0801, Japan.

TEL

043-305-2132

Homepage URL

Email

mutyon88@hotmail.com

Institute

Chiba Prefectural University of Health and Sciences
Department of Rehabilitation Sciences, Division of Physical Therapy

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Kameda medical center

Name of secondary funder(s)

Organization

Kameda medical center

Address

929 Higashicho, Kamogawa, Chiba 296-8602, Japan

Tel

04-7092-2211

Email

clinical_research@kameda.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

04

Month

21

Day

URL releasing protocol

None

Publication of results

Unpublished

URL related to results and publications

None

Number of participants that the trial has enrolled

20

Results

A major effect was observed in the between-participant factor (with stroke fall, without stroke fall, age-matched) (F (2, 28) = 7.66, p < 0.005). Multiple comparison tests showed that the stroke fall group had a significantly lower relative value than the other two groups. Furthermore, the results of the one-sample t-test showed that the stroke fall group had a significantly lower relative value than 1.0 in all observation conditions.

Results date posted

2026

Year

04

Month

21

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Twenty individuals with stroke (nine females) participated. The mean age was 63.9 years (SD = 8.3). Eleven healthy individuals also participated as control participants. Participants in the stroke group were patients in a subacute hospital or had been discharged from a subacute hospital. The mean time from the onset of stroke to testing was 22.0 months (ranging from 1 to 110 months).

Participant flow

Testing was approved by the Ethics Committee of the Kameda Medical Center (approval number 15-080), and all subjects gave written informed consent.The inclusion criteria for stroke patients were: (1) no dementia (MMSE-J score of 24 or higher), (2) motor paralysis due to unilateral brain lesions, (3) no visual impairment, visual field defects, or hemispatial neglect, (4) ability to walk 10 meters 15 times back and forth without assistance, regardless of the use of walking aids or orthotics, and (5) no other neurological or orthopedic diseases affecting walking.

Adverse events

None

Outcome measures

Relative values in perceptual judgment tasks, Mini-Mental State Examination, Timed up and go test, Brunnstrom Recovery Stage

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2015

Year

12

Month

05

Day

Date of IRB

2015

Year

12

Month

15

Day

Anticipated trial start date

2015

Year

12

Month

15

Day

Last follow-up date

2016

Year

03

Month

15

Day

Date of closure to data entry

2016

Year

03

Month

15

Day

Date trial data considered complete

2016

Year

03

Month

15

Day

Date analysis concluded

Other related information

The experimental task was to judge the passability of an aperture. Participants stood at the starting position. They observed apertures of various widths and reported whether they believed they would be able to pass though the aperture without making any contact. A series of apertures was presented to participants using the staircase method. In this method, a series of opening widths was presented in either an ascending or descending order with consecutive 2-cm intervals. The presentation of the series was terminated when the participants alternated their response (i.e., from passable to impassable, or from impassable to passable) a total of six times. Each participant performed one ascending series and one descending series. The perceptual judgment task was performed under four observation conditions: (1) walking condition, (2) standing at 4 m, (3) standing at 1 m, (4) wheelchair condition. Opening widths ranged from 30 cm to 80 cm. In the walking condition, participants initially stood 4 m away from the aperture while looking downward. Upon an auditory cue, they raised their head and walked toward the aperture, stopping at a distance of 1 m. Immediately after stopping, they judged whether the aperture was passable. Vision was then occluded using a white board (42*58 cm). In the standing conditions (4 m and 1 m), participants remained at the designated position and observed the aperture for a duration equivalent to that in the walking condition. After observation, their vision was occluded, and they provided their judgment. In the wheelchair condition, the procedure was identical to the walking condition except that participants were seated in a wheelchair and moved by the experimenter at a speed comparable to their walking speed.

Registered date

2026

Year

04

Month

21

Day

Last modified on

2026

Year

04

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070169