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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
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.
Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
RECRUITINGModified Ashworth Scale
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time frame: Change from Baseline Muscle Tone at 6 months
Brunnstrome Stage
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from Baseline Data at 6 months
Barthel Index
patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time frame: Change from Baseline Data at 6 months
Stroke Impact Scale (SIS)
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patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from Baseline Data at 6 months