UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033463 |
|---|---|
| Receipt number | R000038158 |
| Scientific Title | The effect of repeated botulinum toxin A therapy combined intensive rehabilitation on lower limb spasticity in post- stroke patients. |
| Date of disclosure of the study information | 2018/07/20 |
| Last modified on | 2018/07/20 21:49:49 |
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Basic information
Public title
The effect of repeated botulinum toxin A therapy combined intensive rehabilitation on lower limb spasticity in post- stroke patients.
Acronym
The effect of repeated botulinum toxin A therapy and intensive rehabilitation
Scientific Title
The effect of repeated botulinum toxin A therapy combined intensive rehabilitation on lower limb spasticity in post- stroke patients.
Scientific Title:Acronym
The effect of repeated botulinum toxin A therapy and intensive rehabilitation
Region
| Japan |
Condition
Condition
Chronic stroke patients
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of the present study was to investigate retrospectively the effect of repetitive botulinum toxin A therapy and intensive rehabilitation on lower limb spasticity in post- stroke patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MAS,ROM,FMA,FRT,TUG,10MWT
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
repetitive botulinum toxin A therapy and intensive rehabilitation
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with hemiplegia following a stroke that involved upper and lower limb spasticity
The MAS of ankle score2 at the cycle
6 months since the onset of stroke
No prior BoNT-A injections
No contraindications for BoNT-A injections
The patient desired additional improvements of hemiplegia.
Key exclusion criteria
Only an upper limb for BoNT-A
Can not walk themselves
Taking antispasticity medications
A history of BoNT-A injections
A history of surgery for spasticity due to stroke
Severe cognitive impairment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takatoshi Hara |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitaion Medicine
Zip code
Address
3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo 105-8461, Japan
TEL
0334331111
t_hara1019@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takatoshi Hara |
Organization
The Jikei University School of Medicine
Division name
Department of Rehabilitaion Medicine
Zip code
Address
3-25-8, Nishi-Shimbashi, Minato-Ku Tokyo 105-8461, Japan
TEL
0334331111
Homepage URL
t_hara1019@yahoo.co.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
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 | 07 | Month | 20 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | 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 | 07 | Month | 20 | Day |
Last modified on
| 2018 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038158
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
