UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056244 |
|---|---|
| Receipt number | R000064253 |
| Scientific Title | Walking through apertures in individuals with stroke |
| Date of disclosure of the study information | 2024/11/30 |
| Last modified on | 2024/11/22 18:55:03 |
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Basic information
Public title
Walking through apertures in individuals with stroke
Acronym
Walking through apertures in individuals with stroke
Scientific Title
Walking through apertures in individuals with stroke
Scientific Title:Acronym
Walking through apertures in individuals with stroke
Region
| Japan |
Condition
Condition
individuals with stroke
Classification by specialty
| Neurology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Walking through a narrow aperture requires unique postural configurations, i.e., body rotation in the yaw dimension. Stroke individuals may have difficulty performing the body rotations due to motor paralysis on one side of their body. The present study was therefore designed to investigate how successfully such individuals walk through apertures and how they perform body rotation behavior.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
contact with the frame of an aperture, the absolute body rotation angle, the number of steps necessary to cross an aperture, the body side to penetrate an aperture, the movement speed, and the absolute deviation of the upper-body midpoint from the center of the doorway.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants in the stroke group were patients in a subacute hospital or had been discharged from a subacute hospital. Participants 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 (inclued non-impaired controls) 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.
Target sample size
23
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Muroi |
Organization
Chiba Prefectural University of Health Sciences
Division name
Department of Rehabilitation Sciences, Faculty of Health Care Sciences
Zip code
2600801
Address
645-1 Nitona-cho, Chiba Chuo-ku, Chiba, Japan.
TEL
0433052132
mutyon88@hotmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Muroi |
Organization
Chiba Prefectural University of Health Sciences
Division name
Department of Rehabilitation Sciences, Faculty of Health Care Sciences
Zip code
2600801
Address
645-1 Nitona-cho, Chiba Chuo-ku, Chiba, Japan.
TEL
0433052132
Homepage URL
mutyon88@hotmail.com
Sponsor or person
Institute
Chiba Prefectural University of Health Sciences
Department of Rehabilitation Sciences, Faculty of Health Care Sciences
Daisuke Muroi
Institute
Department
Personal name
Funding Source
Organization
the Japan Society for the Promotion of Science (KAKENHI Grant Number 23K16546)
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 Higashi-cho Kamogawa Chiba, Japan
Tel
0470922211
daisuke.muroi_55@cpuhs.ac.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
| 2024 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0170119
Publication of results
Published
Result
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
46
Results
Stroke fallers made frequent contacts on their paretic side; however, the contacts were not frequent when they penetrated apertures from their paretic side. Although the minimum passable width was greater for stroke fallers, the body rotation angle was comparable among groups. This suggests that frequent contact in stroke fallers was due to insufficient body rotation.
Results date posted
| 2024 | Year | 11 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 01 | Month | 19 | Day |
Baseline Characteristics
Twenty-three individuals with stroke (eleven females) participated. The mean age was 60.7 years (SD = 10.1). Twenty-three age-, gender-, and height-matched healthy individuals also participated as control articipants. 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 15.2 months (ranging from 1 to 78 months).
Participant flow
The experiment consisted of three parts, which included (a) taking clinical measurements and some measurements of participants' characteristics, (b) performing the task of walking through an aperture, and (c) performing a perceptual judgment task regarding aperture passability. Clinical measurements and measurements of participants' characteristics wereconducted first; however, the measurement of the minimum passable width was conducted after performing the two tasks to avoid the possibility that the experience of measuring could affect their performance in these tasks. The order of performing the two tasks was counterbalanced.
Adverse events
None
Outcome measures
Kinematic characteristics at the moment of aperture crossing were described in terms of five measurements: the absolute body rotation angle, the number of steps necessary to cross anaperture (usually representing the steps necessary for body rotation), the body side to penetrate an aperture, the movement speed, and the absolute deviation of the upper-body midpoint from the center of the doorway.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2013 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 30 | Day |
Other
Other related information
The assessment was performed along a straight 6-m path. A door-like opening was located 4 m from the front of where the participants started walking. The opening was created as a space between two projector screens. The width of the opening could be adjusted by changing the location of the edge of each screen. The participants were instructed to walk through an opening without colliding with the screen. There were four different opening widths (cf. 0.9, 1.0, 1.1, 1.2 and 1.3 times the width of the participants' shoulders). As a safety measure for the participants, two therapists stood beside the door apparatus while the participants performed the task. The participants were required to start walking and were permitted to rotate their bodies in any direction when necessary to avoid collisions. They performed 15 trials (three trials for each of the four aperture widths).
Management information
Registered date
| 2024 | Year | 11 | Month | 22 | Day |
Last modified on
| 2024 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064253
