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UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033926
Receipt No. R000038375
Scientific Title The effects of walking through apertures training in individuals with stroke: a randomized controlled trial
Date of disclosure of the study information 2018/09/01
Last modified on 2019/02/27

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Basic information
Public title The effects of walking through apertures training in individuals with stroke: a randomized controlled trial
Acronym The effects of walking through apertures training in individuals with stroke
Scientific Title The effects of walking through apertures training in individuals with stroke: a randomized controlled trial
Scientific Title:Acronym The effects of walking through apertures training in individuals with stroke
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 partients.
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)
Activities-specific Balance Confidence (ABC) Scale
Walking speed and trunk rotation angle at the time of passage
Falls incident after six months

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 In the intervention group, 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.
Interventions/Control_2 In the control group, participants walk through a sufficiently wide width (180 cm) without rotation at the same place, distance and duration as the intervention group.
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 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, (b) history of visual deficits, (c) visual field deficits and visual spatial neglect, and (d) a score of less than 24 on the Mini Mental State Examination (MMSE)
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daisuke Muroi
Organization Kameda Rehabilitation Hospital
Division name Department of Rehabilitation
Zip code
Address 975-2 Higashicho, Kamogawa, Chiba 296-8602, Japan
TEL 04-7093-1400
Email mutyon88@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Daisuke Muroi
Organization Kameda Rehabilitation Hospital
Division name Department of Rehabilitation
Zip code
Address 975-2 Higashicho, Kamogawa, Chiba 296-8602, Japan
TEL 04-7093-1400
Homepage URL
Email mutyon88@hotmail.com

Sponsor
Institute Kameda Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 亀田リハビリテーション病院(千葉県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 08 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 08 Month 28 Day
Last modified on
2019 Year 02 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038375

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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