UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015067 |
|---|---|
| Receipt number | R000017438 |
| Scientific Title | The efficacy of combination of botulinum toxin A and functional electrical stimulation in the treatment of upper limb flexor spasticity after stroke |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2014/08/28 22:36:39 |
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Basic information
Public title
The efficacy of combination of botulinum toxin A and functional electrical stimulation in the treatment of upper limb flexor spasticity after stroke
Acronym
The efficacy of combination of botulinum toxin A and functional electrical stimulation in the treatment of upper limb flexor spasticity after stroke
Scientific Title
The efficacy of combination of botulinum toxin A and functional electrical stimulation in the treatment of upper limb flexor spasticity after stroke
Scientific Title:Acronym
The efficacy of combination of botulinum toxin A and functional electrical stimulation in the treatment of upper limb flexor spasticity after stroke
Region
| Japan |
Condition
Condition
Stroke
Classification by specialty
| Neurology | Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the combined efficacy of botulinum toxin A and functional electrical stimulation with upper limb flexor spasticity after stroke
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Fugel-Meyer Assessment
Modified Ashworth Scale
Range of motion
Key secondary outcomes
Motor Activity Log
Activity of daily living
Quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
The combination group of botulinum toxin A injection and functional electrical stimulation
Interventions/Control_2
Control group of only botulinum toxin A injection
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
1)Neurology outpatinents who are treated with botulinum toxin A injection
2)Total injection volume of botulinum toxin A 200-240 units
3)Forearm injection of botulinum toxin A at least 50 units
4)Hemiplegia or monoplegia at least 6 months after stroke
5)Grade 3 as measured by the Modified Ashworth Scale
6)Upper limb flexor spasticity
7)Patients who can follow multi-step instructions
8)Patients who can read control unit
9)Patients who can fit FES instrument
10)Patients who can fit FES instrument by themselves or be fitted by family
11)Patients who can't extend complete fingers in a neutral position
12)Obtained informed consent
Key exclusion criteria
1)Implanted medical electrical equipment including pacemaker
2)Skin lesion at electrode attachment
3)Infection or malignant tumor within upper limb
4)Pregnant woman
5)Patients who have metal implant or arteriovenous shunt for dialysis in the affected forearm and hand
6)Past history of seizure
7)Severe deformity of wrist or fingers
8)Severe limitation of ROM because of past fracture
9)Past history of neurological deficit derived from cervical spine or peripheral nerve
10)No adaptation to botulinum toxin A
11)Not obtained informed consent
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinsuke Katoh |
Organization
Tokushima University Hospital
Division name
Department of Rehabilitation
Zip code
Address
2-50-1 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL
088-633-9313
skatoh@tokushimapu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nori Sato |
Organization
Tokushima University Hospital
Division name
Department of Rehabilitation
Zip code
Address
2-50-1 Kuramoto-cho, Tokushima, 770-8503, Japan
TEL
088-633-9313
Homepage URL
norih@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
France Bed Holdings Co. Ltd.
(Not research fund but free rent of functional electrical stimulation)
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
| 2014 | Year | 10 | 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
| 2014 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | 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
| 2014 | Year | 09 | Month | 05 | Day |
Last modified on
| 2014 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017438
