UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043204 |
|---|---|
| Receipt number | R000049305 |
| Scientific Title | Temporal changes in neuromuscular fatigue and gait ability during extended walking in people with hemiplegia |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2021/08/03 09:27:01 |
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Basic information
Public title
Temporal changes in neuromuscular fatigue and gait ability during extended walking in people with hemiplegia
Acronym
Temporal changes in neuromuscular fatigue and gait
Scientific Title
Temporal changes in neuromuscular fatigue and gait ability during extended walking in people with hemiplegia
Scientific Title:Acronym
Temporal changes in neuromuscular fatigue and gait
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The present study aimed to clarify temporal changes in gait performance and lower limb muscle activity during extended walking in people with stroke hemiplegia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The electromyography amplitude during extended trial involving walking continuously for 20 min at a comfortable speed.
Key secondary outcomes
The walking performance and the instantaneous mean frequency of the electromyography during extended trial involving walking continuously for 20 min at a comfortable speed.
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(i) pyramidal tract damage due to unilateral cerebral lesions in poststroke patients, (ii) a period of at least 6 months since the onset of stroke, (iii) ability to walk independently for more than 20 min continuously and (iv) no pain reported in the body during walking. The exclusion criteria were as follows: (i) history of lower limb joint surgery, (ii) Mini-Mental State Examination score of <24 points, and (iii) treatment received for cardiovascular disease and/or respiratory disease
Key exclusion criteria
(i) history of lower limb joint surgery, (ii) Mini-Mental State Examination score of <24 points, and (iii) treatment received for cardiovascular disease and/or respiratory disease
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Kazuki |
| Middle name | |
| Last name | Fujita |
Organization
Fukui Health Science University
Division name
Faculty of Health Science, Department of Rehabilitation
Zip code
910-3190
Address
55-13-1 Egami Fukui-city
TEL
+81776592201
k.fujita@fukui-hsu.ac.jp
Public contact
Name of contact person
| 1st name | Kazuki |
| Middle name | |
| Last name | Fujita |
Organization
Fukui Health Science University
Division name
Faculty of Health Science, Department of Rehabilitation
Zip code
910-3190
Address
55-13-1 Egami Fukui-city
TEL
+81776592201
Homepage URL
k.fujita@fukui-hsu.ac.jp
Sponsor or person
Institute
Fukui Health Science University
Institute
Department
Personal name
Funding Source
Organization
Fukui Health Science University
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
Nittazuka Medical Welfare Center
Address
58-16-1 Egami, Fukui-city
Tel
0776591300
fgh-hisyo@mopera.net
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 | 02 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Subjects performed an extended walking trial that involved them walking continuously for 20 min at a comfortable speed on the first day of hospitalization. This trial used a 20m horizontal straight walkway, with the subjects walking lengths back and forth. Subjects with a high risk of falling due to toe dragging during the swing phase were allowed to use an ankle foot orthosis, however, to minimize impacts on the data gathered, ORTOP was used in which the plastic body was short, thin, and light. Therefore, this ankle foot orthosis has a weak fixing force and the ankle joint moved slightly when walking. The criteria for discontinuation of a trial were: if subjects exceeded 70% of their maximum heart rate, or the rating of perceived exertion was 6 points or higher.
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2021 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049305
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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