UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043986
Receipt number R000050235
Scientific Title Walking through an aperture while leading paretic side training for patients with unilateral spatial neglect
Date of disclosure of the study information 2021/04/21
Last modified on 2023/03/01 11:42:31

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Basic information

Public title

Walking through an aperture while leading paretic side training for patients with unilateral spatial neglect

Acronym

Walking through an aperture training for patients with unilateral spatial neglect

Scientific Title

Walking through an aperture while leading paretic side training for patients with unilateral spatial neglect

Scientific Title:Acronym

Walking through an aperture training for patients with unilateral spatial neglect

Region

Japan


Condition

Condition

Stroke

Classification by specialty

Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate whether obstacle avoidance training that passing through a narrow aperture from the paretic side contributes to the improvement of contact rate, walking ability, and balance ability for the stroke patients with unilateral spatial neglect.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The mean percentage of contacts with the frame of an aperture (The timing of the measurement is before and after the intervention)

Key secondary outcomes

The following assessment excluding the falls incident is carried out before and after the intervention.
10m walking test (10MWT)
Timed up and Go Test (TUG)
Berg Blance Scale (BBS)
Catherine Bergego Scale (CBS)
Walking speed and trunk rotation angle at the time of passage


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

In the intervention periods for three weeks, participants through a narrow aperture (0.9, 1.0.1.1, 1.2 times of their shoulder width) in the walking path of 5 m, five times a week for 40 minutes. If they decide that it is necessary to rotate, they penetrate an aperture from the paretic side.
In the control or follow up periods for three weeks, participants received regular physical therapy intervention.

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


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Participants were patients with unilateral spatial neglect in a subacute hospital and they had residual hemiparesis.
The inclusion criteria ensured that participants had been walking for at least one month after a first-time stroke and that they were able to walk independently for more than 100 m with or without an assistive device.

Key exclusion criteria

The exclusion criteria ensured that none of the participants had any indications of the following symptoms: (a) neurological, orthopedic, or other disorders that could affect walking, and (b) a score of less than 24 on the Mini Mental State Examination (MMSE)

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Muroi

Organization

Kameda University of Health Science

Division name

Research Institute

Zip code

296-0001

Address

462 Yokosuka, Kamogawa, Chiba 296-0001, Japan

TEL

0470991211

Email

mutyon88@hotmail.com


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Muroi

Organization

Kameda University of Health Science

Division name

Research Institute

Zip code

296-0001

Address

462 Yokosuka, Kamogawa, Chiba 296-0001, Japan

TEL

0470991211

Homepage URL


Email

mutyon88@gmail.com


Sponsor or person

Institute

Kameda Medical Center

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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

Kameda Medical Center

Address

929 Higashicho, Kamogawa, Chiba 296-8602, Japan

Tel

0470922211

Email

clinical_research@kameda.jp


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



Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 21 Day


Related information

URL releasing protocol

https://www.tandfonline.com/doi/full/10.1080/13554794.2022.2042566

Publication of results

Partially published


Result

URL related to results and publications

https://www.tandfonline.com/doi/full/10.1080/13554794.2022.2042566

Number of participants that the trial has enrolled

1

Results

The intervention improved the continuous
walking distance and balance ability and decreased the number of collisions when walking through the narrow opening; however, it exerted a minimal effect on ADL.

Results date posted

2022 Year 10 Month 22 Day

Results Delayed

Delay expected

Results Delay Reason

Due to a lack of cases.

Date of the first journal publication of results

2022 Year 02 Month 10 Day

Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD

Accepted by an international journal (Neurocase).

IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2018 Year 08 Month 10 Day

Date of IRB

2018 Year 08 Month 10 Day

Anticipated trial start date

2018 Year 08 Month 10 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 31 Day

Date trial data considered complete

2022 Year 03 Month 31 Day

Date analysis concluded

2023 Year 08 Month 31 Day


Other

Other related information



Management information

Registered date

2021 Year 04 Month 20 Day

Last modified on

2023 Year 03 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050235


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name