Cerebrovascular Accident
Conditions
Keywords
stroke, upper extremity, spasticity, botulinum toxin, ultrasonography, electric stimulation
Brief summary
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
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.
Interventions
DRUGBotulinum Toxin Type A
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.
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Ashworth Scale | Change from Baseline Muscle Tone at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Active Range of Motion | Change from Baseline Data at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
| 4 Point Categorical Pain Intensity Scale | Change from Baseline Data at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
| Hand-grasp strength Assessment | Change from Baseline Data at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
| Pinch Strength Assessment | Change from Baseline Data at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
| Barthel Index | Change from Baseline Data at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
| Stroke Impact Scale (SIS) | Change from Baseline Data at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
| Brunnstrome Stage | Change from Baseline Condition at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
| Wolf Motor Function Test | Change from Baseline Data at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
| Chedoke Arm and Hand Activity Inventory (CAHAI) | Change from Baseline Data at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
| Fugl-Meyer Assessment | Change from Baseline Data at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
| Motor Activity Log Scale | Change from Baseline Data at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
| Nine Hole Peg Test | Change from Baseline Data at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
| Action Research Arm Test (ARAT) | Change from Baseline Data at 6 months | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection |
Countries
Taiwan
Contacts
Primary ContactPong Ya-Ping, MD
Outcome results
None listed