Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity

Sponsor

Medy-Tox (Industry)

Overall Status

Completed

CT.gov ID

NCT02757404

Collaborator

(none)

Enrollment

Arms

2.6

Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Muscle Spasticity	Drug: Ultrasonography guidance injection of Meditoxin®. Drug: Electrical stimulation guidance injection of Meditoxin®. Drug: Manual needle placement injection of Meditoxin®.	Phase 4

Detailed Description

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".

Study Design

Study Type:

Interventional

Actual Enrollment :

59 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity

Actual Study Start Date :

May 30, 2016

Actual Primary Completion Date :

Aug 16, 2016

Actual Study Completion Date :

Aug 16, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ultrasonography guidance Ultrasonography guidance injection of Meditoxin®.	Drug: Ultrasonography guidance injection of Meditoxin®. Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance.
Experimental: Electrical stimulation guidance Electrical stimulation guidance injection of Meditoxin®.	Drug: Electrical stimulation guidance injection of Meditoxin®. Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance.
Experimental: Manual needle placement Manual needle placement injection of Meditoxin®.	Drug: Manual needle placement injection of Meditoxin®. Meditoxin® will be injected to upper limb spasticity by using the manual needle placement.

Arm

Intervention/Treatment

Experimental: Ultrasonography guidance

Ultrasonography guidance injection of Meditoxin®.

Drug: Ultrasonography guidance injection of Meditoxin®.

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

Experimental: Electrical stimulation guidance

Electrical stimulation guidance injection of Meditoxin®.

Drug: Electrical stimulation guidance injection of Meditoxin®.

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

Experimental: Manual needle placement

Manual needle placement injection of Meditoxin®.

Drug: Manual needle placement injection of Meditoxin®.

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

Outcome Measures

Primary Outcome Measures

Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms. [4 weeks]

Secondary Outcome Measures

Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms. [4 weeks]
Comparison evaluation on improvement rate of range of motion on each joint between 3 arms. [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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