Hand Rehabilitation Using Botulinum Toxin and Functional Electrical Stimulation-pilot Study

NCT ID: NCT03549975

Last Updated: 2018-06-08

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-18

Study Completion Date

2017-08-18

Brief Summary

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The investigator tried to find out possibility of functional improvement using botulinum toxin injection targeting finger flexor spasticity with functional electrical stimulation among chronic stroke patients who did not show any improvement in hand function.

Detailed Description

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Conditions

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Stroke Spastic Hemiparesis Spasticity as Sequela of Stroke

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Botulinum toxin type A injection

Botulinum toxin type A injection followed by functional electrical stimulation

Group Type EXPERIMENTAL

Botulinum Toxin Type A 100 unit/Vial (Product)

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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functional electrical stimulation

Eligibility Criteria

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Inclusion Criteria

* age over 18 years
* 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

* fixed contracture
* 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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Rehabilitation Center, Seoul, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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Joon-Ho Shin

Team manager of Department of Neurorehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

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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