UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032170 |
|---|---|
| Receipt number | R000036702 |
| Scientific Title | Combined effects of botulinum toxin and splinting therapy on upper limb spasticity |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2018/04/10 18:12:13 |
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Basic information
Public title
Combined effects of botulinum toxin and splinting therapy on upper limb spasticity
Acronym
Combined effects of botulinum toxin and splinting therapy on upper limb spasticity
Scientific Title
Combined effects of botulinum toxin and splinting therapy on upper limb spasticity
Scientific Title:Acronym
Combined effects of botulinum toxin and splinting therapy on upper limb spasticity
Region
| Japan | Asia(except Japan) |
Condition
Condition
patients with upper limb spasticity
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine combined effects of botulinum toxin and splinting therapy on upper limb spasticity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
passive range of motion
Key secondary outcomes
Modified Ashworth Scale
Brunnstrom recorvery stage
Disability assessment scale
attachment time of splint
status of implementation of self training
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
botulinum toxin combined with splinting therapy(sleep time, three month period)
Interventions/Control_2
botulinum therapy alone(three month period)
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
1)patients with post-stroke hemiparesis, upper limb spasticity,6 month or more after stroke onset.
2)patients with Brunnstrome recovery stage 2 or 3
Key exclusion criteria
1)patients with no adaptation to botulinum toxin A
2)Patients with disturbance of consciousness or higher brain dysfunction who were considered to be inappropriate to participate in the study
3)Patients with severe limitation of range of motion because of joint contracture
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoya Kitade |
Organization
Hamamatsu City Rehabilitation Hospital
Division name
Rehabilitaition
Zip code
Address
Shizuoka Prefecture Hamamatsu City Wagoukita1-6-1
TEL
053-471-8331
kitade-to@sis.seirei.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoya Kitade |
Organization
Hamamatsu City Rehabilitation Hospital
Division name
Rehabilitaition
Zip code
Address
Shizuoka Prefecture Hamamatsu City Wagoukita1-6-1
TEL
053-471-8331
Homepage URL
kitade-to@sis.seirei.or.jp
Sponsor or person
Institute
Hamamatsu City Rehabilitation Hospital
Institute
Department
Personal name
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
Address
Tel
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
| 2018 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 09 | Day |
Last modified on
| 2018 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036702
