UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042313 |
|---|---|
| Receipt number | R000048306 |
| Scientific Title | Functional prognosis prediction for the effect of botulinum toxin therapy on upper limb in post-stroke patients using hierarchical cluster analysis |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2020/11/01 16:02:36 |
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Basic information
Public title
Functional prognosis prediction for the effect of botulinum toxin therapy on upper limb in post-stroke patients using hierarchical cluster analysis
Acronym
The effect of botulinum toxin therapy on upper limb in post-stroke patients using hierarchical cluster analysis
Scientific Title
Functional prognosis prediction for the effect of botulinum toxin therapy on upper limb in post-stroke patients using hierarchical cluster analysis
Scientific Title:Acronym
The effect of botulinum toxin therapy on upper limb in post-stroke patients using hierarchical cluster analysis
Region
| Japan |
Condition
Condition
Post stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By analyzing BoNT-A and intensive rehabilitation for patients with post-stroke upper limb hemiparesis by a more detailed classification of upper limb function, the effect is verifyand the functional prognosis is predicted.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The Fugl-Meyer Assessment (FMA)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
botulinum toxin A + intensive rehabilitation
Interventions/Control_2
usual rehabilitation
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) patients with hemiplegia following a stroke that involved upper limb spasticity (with a Modified Ashworth Scale score equal to or greater than 1; (2) >6 months since the onset of stroke; (3) no prior BoNT- A injections; (4) no contraindications for BoNT-A injections.
Key exclusion criteria
(1) taking anti-spasticity medications, and (2) a history of BoNT-A injections.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Takatoshi |
| Middle name | |
| Last name | Hara |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitaion Medicine
Zip code
105-8461
Address
Department of Rehabilitaion Medicine
TEL
+81-3-3433-1111
t_hara1019@jikei.ac.jp
Public contact
Name of contact person
| 1st name | Takatoshi |
| Middle name | |
| Last name | Hara |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitaion Medicine
Zip code
105-8461
Address
3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo 105-8461, Japan
TEL
+81-3-3433-1111
Homepage URL
t_hara1019@jikei.ac.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None declared.
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
The Jikei University School of Medicine
Address
3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo 105-8461, Japan
Tel
+81-3-3433-1111
t_hara1019@jikei.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
| 2020 | Year | 11 | 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
130
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
Completed
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 01 | Day |
Last modified on
| 2020 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048306
