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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033463
Receipt No. 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

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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
Email 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
Email t_hara1019@yahoo.co.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038158

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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