UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033926 |
|---|---|
| Receipt number | 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 | 2025/02/03 09:12:56 |
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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 patients.
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 | Daisuke |
| Middle name | |
| Last name | Muroi |
Organization
Kameda Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
296-0041
Address
975-2 Higashicho, Kamogawa, Chiba 296-8602, Japan
TEL
04-7093-1400
mutyon88@hotmail.com
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Muroi |
Organization
Kameda Rehabilitation Hospital
Division name
Department of Rehabilitation
Zip code
296-0041
Address
975-2 Higashicho, Kamogawa, Chiba 296-8602, Japan
TEL
04-7093-1400
Homepage URL
mutyon88@hotmail.com
Sponsor or person
Institute
Kameda Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (KAKENHI Grant Number 19K19845 [Daisuke Muroi]
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 General Hospital
Address
929 Higashi-cho Kamogawa Chiba, Japan
Tel
04-7092-2211
muroi.daisuke@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
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
38
Results
Collision rate and time to passage of the opening in obstacle avoidance task significantly improved in the T-WTO group compared with those in the R-Control group. Contrastingly, T-WTO did not lead to significant improvements in other outcomes.
Results date posted
| 2021 | Year | 08 | Month | 30 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
under review
Date of the first journal publication of results
| 2022 | Year | 12 | Month | 31 | Day |
Baseline Characteristics
Participant flow
Adverse events
None
Outcome measures
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 at the time of passage
Falls incident after six months
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2021 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 28 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038375
