UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048465 |
|---|---|
| Receipt number | R000054945 |
| Scientific Title | Effect of Trunk Solution combined with exercise in chronic stroke survivors |
| Date of disclosure of the study information | 2022/07/26 |
| Last modified on | 2023/01/26 12:28:09 |
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Basic information
Public title
Effect of Trunk Solution combined with exercise in chronic stroke survivors
Acronym
Effect of Trunk Solution combined with exercise in chronic stroke survivors
Scientific Title
Effect of Trunk Solution combined with exercise in chronic stroke survivors
Scientific Title:Acronym
Effect of Trunk Solution combined with exercise in chronic stroke survivors
Region
| Japan |
Condition
Condition
chronic stroke survivors
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of Trunk Solution combined with exercise on walking speed in chronic stroke survivors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
walking speed
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Walking exercise with trunk solution
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic stroke victims
(6 months after stroke onset or later)
(Stroke Impairment Assessment - motor function lower limb <15 )
Key exclusion criteria
Barthel IndexI gait items < 10
Difficulty fitting a trunk solution
Progressive disease
Walking speed > 1.0 m/sec
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Kyohei |
| Middle name | |
| Last name | Kuramoto |
Organization
Nishinomiyakaisei hospital
Division name
Rehabilitation department
Zip code
662-0957
Address
1-4 Ohamacho Nishinomiya-shi Hyogo-ken
TEL
0798-33-0601
kuramoto.kyohei@hmw.gr.jp
Public contact
Name of contact person
| 1st name | Kyohei |
| Middle name | |
| Last name | Kuramoto |
Organization
Nishinomiyakaisei hospital
Division name
Rehabilitation department
Zip code
662-0957
Address
1-4 Ohamacho Nishinomiya-shi Hyogo-ken
TEL
0798-33-0601
Homepage URL
kuramoto.kyohei@hmw.gr.jp
Sponsor or person
Institute
Nishinomiyakaisei hospital
Institute
Department
Personal name
Funding Source
Organization
Nishinomiyakaisei hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nishinomiyakaisei hospital ethics comittee
Address
1-4 Ohamacho Nishinomiya-shi Hyogo-ken
Tel
0798-33-0601
kuramoto.kyohei@hmw.gr.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
| 2022 | Year | 07 | Month | 26 | 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
Terminated
Date of protocol fixation
| 2022 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 26 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 07 | Month | 26 | Day |
Last modified on
| 2023 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054945
