UMIN-ICDS Clinical Trial

Public title

Examination of a safe aperture passage method for stroke patients with hemiplegia

Acronym

Examination of a safe aperture passage method for stroke patients with hemiplegia

Scientific Title

Examination of a safe aperture passage method for stroke patients with hemiplegia

Scientific Title:Acronym

Examination of a safe aperture passage method for stroke patients with hemiplegia

Region

Japan

Condition

Stroke patients with hemiplegia

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify the spontaneous aperture-passing behavior of stroke patients.
Moreover, to examine whether instructing stroke patients to enter a narrow aperture from the paralyzed side contributes to reducing the collision rate.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

collision rate, head rotarion angle, shoulder rotation angle, pelvis rotarion angle, crossing pattern

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

50

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

043-305-2169

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

043-305-2169

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

2023

Year

08

Month

15

Day

URL releasing protocol

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0170119

Publication of results

Partially published

URL related to results and publications

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0170119

Number of participants that the trial has enrolled

23

Results

Individuals with stroke with previous falls were less likely to have a collision when penetrating from the paretic side. The stroke fall group was likely to experience more collisions
because of deleterious changes in body rotation angle and movement speed in narrow apertures. Moreover, individuals with stroke have many unexpected collisions, but the decline in anticipatory ability was not unique to the stroke fall group.

Results date posted

2023

Year

08

Month

12

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2017

Year

01

Month

19

Day

Baseline Characteristics

Twenty-five individuals with stroke (including 10 females) with a mean age of 66.9 years (standard deviation [SD] = 5.7) participated. Participants were categorized into two groups based on their fall history: stroke fall group and stroke non-fall group. Participants categorized into stroke fall group reported that they had fallen within the past 12 months. Twelve individuals were categorized in the stroke fall group (mean age: 67.9, [SD] = 4.0 years) and 13 individuals were categorized in the stroke non-fall group (mean age: 65.2, [SD] = 7.1 years).

Participant flow

The study participants were patients who were currently staying in a subacute hospital or had been discharged from a subacute hospital. The mean time from the onset of stroke to testing was 25.9 (range, 1-123) months.

Adverse events

None

Outcome measures

collision rate, percentage of collision frequency classified according to the body side, absolute angles of shoulder rotation, absolute deviation of the upper-body midpoint from the center of the doorway, absolute movement speed of crossing

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

06

Month

05

Day

Date of IRB

2013

Year

06

Month

10

Day

Anticipated trial start date

2013

Year

08

Month

01

Day

Last follow-up date

2018

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

First experimental task was spontaneous walking through apertures of various widths. Participants were asked to approach and walk through an aperture without making any contact with a creen. There were four different aperture widths: 0.9, 1.0, 1.1, and 1.2 times the width of participants' shoulders. The participants performed a total of 12 main trials (three trials for each of the four aperture widths). In the second expriment, each participant performed the walking task under each of the two conditions: penetration from the paretic side and penetration from the non-paretic side. The participants performed a total of 12 main trials per side (three trials for each of the four aperture widths). A total of 24 trials were conducted per participant.

Registered date

2023

Year

08

Month

12

Day

Last modified on

2023

Year

08

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059214