Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation-pilot Study
NCT ID: NCT03549975
Last Updated: 2018-06-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
20 participants
INTERVENTIONAL
2016-05-18
2017-08-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Botulinum toxin type A injection
Botulinum toxin type A injection followed by functional electrical stimulation
Botulinum Toxin Type A 100 unit/Vial (Product)
Botulinum toxin type A injection followed by functional electrical stimulation
Interventions
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Botulinum Toxin Type A 100 unit/Vial (Product)
Botulinum toxin type A injection followed by functional electrical stimulation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* hemiplegic upper limb spasticity secondary to a unilateral ischemic or hemorrhagic stroke
* fingers and wrist flexor spasticity graded at least 1+ on the Modified Ashworth Scale
* at least 6 months since stroke
Exclusion Criteria
* previous treatment of the upper limb spasticity with neurolytic or surgical procedure
* treatment with botulinum toxin type A in the previous 4 months
* any active device implant
* any neurological disorder, other than stroke causing motor deficits or spasticity
* inability to attend to and/or to cooperate with all outcome measure-related task secondary to cognitive impairment or aphasia
* pregnancy, planned pregnancy, or lactation
* contraindication to botulinum toxin type A
19 Years
ALL
No
Sponsors
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National Rehabilitation Center, Seoul, Korea
OTHER_GOV
Responsible Party
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Joon-Ho Shin
Team manager of Department of Neurorehabilitation
Principal Investigators
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Joon-Ho Shin, MS
Role: PRINCIPAL_INVESTIGATOR
National Rehabilitation Center of Korea
Other Identifiers
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NRC-2016-02-011
Identifier Type: -
Identifier Source: org_study_id
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