UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050052 |
|---|---|
| Receipt number | R000057021 |
| Scientific Title | The effect of exercise-induced hypoalgesia in patients with hemiplegia after stroke: a randomized controlled trial |
| Date of disclosure of the study information | 2023/01/17 |
| Last modified on | 2025/01/21 18:37:12 |
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Basic information
Public title
The effect of exercise-induced hypoalgesia in patients with hemiplegia after stroke: a randomized controlled trial
Acronym
The effect of exercise-induced hypoalgesia in patients with hemiplegia
Scientific Title
The effect of exercise-induced hypoalgesia in patients with hemiplegia after stroke: a randomized controlled trial
Scientific Title:Acronym
The effect of exercise-induced hypoalgesia in patients with hemiplegia
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 examine the effect of exercise-induced hypoalgesia in patients with hemiplegia after stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Quantitative sensory testing
Key secondary outcomes
Physical function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Usual physiotherapy (40- 60 minutes, seven times a week ) and aerobic exercise (15- 20 minutes, three times a week)
Four weeks
Interventions/Control_2
Usual physiotherapy (60 minutes)
Four weeks
Seven times a week
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)first ever confirmed supratentorial stroke
(2)mini mental status examination of 24 or higher
(3)functional capability to perform lower limb pedaling
Key exclusion criteria
(1)traumatic brain injury, bilateral hemispheric and infratentorial lesions
(2)bodily or visuospatial hemineglect, apraxia, attention disorders and aphasia
(3)pain existed prior to the onset of stroke
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Takako |
| Middle name | |
| Last name | Matsubara |
Organization
Kobe Gakuin University
Division name
Graduate School of Rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, JAPAN
TEL
(078)974-1551
matsubar@reha.kobegakuin.ac.jp
Public contact
Name of contact person
| 1st name | Takako |
| Middle name | |
| Last name | Matsubara |
Organization
Kobe Gakuin University
Division name
Graduate School of Rehabilitation
Zip code
651-2180
Address
518 Arise, Ikawadani-cho, Nishi-ku, Kobe 651-2180, JAPAN
TEL
(078)974-1551
Homepage URL
matsubar@reha.kobegakuin.ac.jp
Sponsor or person
Institute
Kobe Gakuin University
Institute
Department
Personal name
Takako Matsubara
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
/Kobe Gakuin University
Address
518, Arise, Ikawadani-cho, Nishi-ku, Kobe, Japan
Tel
(078) 974-1551
ethic@reha.kobegakuin.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
岸和田リハビリテーション病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | Month | 17 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057021
