Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

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

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-30

Study Completion Date

2016-08-16

Brief Summary

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Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.

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Detailed Description

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This study is "A Multicenter, Prospective, Randomized, Evaluator Blinded, Comparing Phase 4 Study to Evaluate the Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity".

Conditions

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Muscle Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Ultrasonography guidance

Ultrasonography guidance injection of Meditoxin®.

Group Type EXPERIMENTAL

Ultrasonography guidance injection of Meditoxin®.

Intervention Type DRUG

Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance.

Electrical stimulation guidance

Electrical stimulation guidance injection of Meditoxin®.

Group Type EXPERIMENTAL

Electrical stimulation guidance injection of Meditoxin®.

Intervention Type DRUG

Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance.

Manual needle placement

Manual needle placement injection of Meditoxin®.

Group Type EXPERIMENTAL

Manual needle placement injection of Meditoxin®.

Intervention Type DRUG

Meditoxin® will be injected to upper limb spasticity by using the manual needle placement.

Interventions

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Ultrasonography guidance injection of Meditoxin®.

Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance.

Intervention Type DRUG

Electrical stimulation guidance injection of Meditoxin®.

Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance.

Intervention Type DRUG

Manual needle placement injection of Meditoxin®.

Meditoxin® will be injected to upper limb spasticity by using the manual needle placement.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female subject aged over 20.
2. Subjects who has grade 1 + and more spasticity at least one of upper limb muscles as measured on Modified Ashworth Scale after stroke.
3. Subjects who was diagnosed stroke at least 1 month prior to study participation.
4. Subjects or legal representatives who voluntarily decided the participation of the study and signed the informed consent.

Exclusion Criteria

1. Subjects who had spinal injuries to be a factor of spasticity except for stroke prior to study enrollment.
2. Subjects with allergy or hypersensitivity to the Botulinum Toxin.
3. Subjects who have changed the muscle relaxant taking for treatment within past 4 weeks prior to study participation.
4. Subjects who have taken injection treatments using alcohol or phenol in upper limb within past 6 months prior to study participation.
5. Subjects with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis).
6. Subjects who have been injected with botulinum toxin within past 3 months before the injection.
7. Subjects who are pregnant or lactating of disagreed to avoid pregnancy during 3 months study period.
8. Subjects who are scheduled to take part in other clinical trial during the study period.
9. Patients who are not eligible for this study at the medical discretion of the investigator.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No