Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Upper Extremities

Study Overview
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Brief Summary
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The aims of this study were to compare the injection locations of key spastic muscles on upper extremity by three different guidance localization methods ( surface anatomy landmark, ultrasonography, electric stimulation) and the effectiveness.

Detailed Description
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Stroke may result in acute or chronic hemiplegia and spasticity in stroke patients. Spasticity in upper extremities may interfere with motor voluntary function, activities of daily living and cause muscle pain. Botulinum toxin type A (BTX-A) has been shown to relieve spasticity and pain in upper extremities of stroke patients. There are no researches to compare the efficiency of BTX-A by different injection guidance methods in stroke patients. The aims of our study were to compare the injection locations of key spastic muscles on upper extremity by three different guidance localization methods ( surface anatomy landmark, ultrasonography, electric stimulation) and the effectiveness. The investigators will enroll 60 hemiplegic stroke patients with upper extremity spasticity more than modified Ashworth scale ( MAS) 1+ and duration more than 6 months. Under different guidance methods (surface anatomy landmark/ ultrasonography /electric stimulation ), BTX-A will be injected to the key spastic muscles on upper extremity. Outcome measures include MAS, motor function ( Brunnstrom stage of upper extremity), range of motion , the degree and visual analog scale of pain , pinch and grasp power，Stroke Impact Scale, Barthel index and upper extremity function (Nine hole peg test，Action Reaearch Arm Test，Wolf Motor Function test，Chedoke Arm and Han Activity Inventory，Fugl-Meyer Assessment Scale，Motor Activity Log). All the assessments will be performed before BTX-A injection and followed up at 4 weeks, 8 weeks, 12 weeks and 24 weeks after injection. After performing all the assessments, investigators will investigate the efficiency of BTX-A by different guidance methods. Four of arms: ultrasonography direct-guidance: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance. ultrasonography indirect-guidance: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography indirect-guidance. electric stimulation guidance: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by electric stimulation guidance. surface anatomy landmark: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by surface anatomy landmark.

Official Title
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Comparison of Surface Landmark, Ultrasonography and Electric Stimulation Guidance for Botulinum Toxin Injections in Stroke Patients With Spasticity on Upper Extremities.

Conditions
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Cerebrovascular Accident

Intervention / Treatment
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* Drug: Botulinum Toxin Type A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first onset. at least onset before 6 months. elbow, wrist and fingers are above Modified Ashworth Scale(MAS) 1+. Mini-Mental State Exam above 24. can follow all of the follow up and instruction. patients never accept botox, phenol and alcohol injections before. Exclusion Criteria: contracture deformity on upper extremity. patients had accepted botox before or had have phenol, alcohol injections and operation 6 months ago. allergy to botox. have neither infection nor skin disorder on inject site. now accept aminoglycoside or other medicine treatment which may affect neuromuscular transition. combine other systemic disease of neurological or skelectomuscular system cognition disorder or aphasia after stroke.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasonography direct-guidance<br>To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance. | Drug: Botulinum Toxin Type A<br>* To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance, Ultrasonography direct-guidance, Electric stimulation and Surface anatomy landmark.<br>* Other names: Botulinum toxin;|
| Experimental: Electric stimulation<br>To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Electric stimulation | Drug: Botulinum Toxin Type A<br>* To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance, Ultrasonography direct-guidance, Electric stimulation and Surface anatomy landmark.<br>* Other names: Botulinum toxin;|
| Active Comparator: Surface anatomy landmark<br>To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Surface anatomy landmark. | Drug: Botulinum Toxin Type A<br>* To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance, Ultrasonography direct-guidance, Electric stimulation and Surface anatomy landmark.<br>* Other names: Botulinum toxin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Muscle Tone at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brunnstrome Stage | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Condition at 6 months | 
| Active Range of Motion | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | 
| 4 Point Categorical Pain Intensity Scale | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | 
| Hand-grasp strength Assessment | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | 
| Pinch Strength Assessment | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | 
| Barthel Index | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | 
| Stroke Impact Scale (SIS) | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | 
| Action Research Arm Test (ARAT) | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | 
| Wolf Motor Function Test | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | 
| Chedoke Arm and Hand Activity Inventory (CAHAI) | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | 
| Fugl-Meyer Assessment | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | 
| Motor Activity Log Scale | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | 
| Nine Hole Peg Test | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stroke, upper extremity, spasticity, botulinum toxin, ultrasonography, electric stimulation