Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Lower Extremities
Status:
Unknown status
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
Summary
Stroke may result in lower extremity spasticity, which interfere with motor voluntary
function and activities of daily living. Botulinum toxin type A (BTX-A) has been shown to
improve lower extremity spasticity of stroke patients. There are no researches to compare the
efficiency of BTX-A injection by different guidance methods in the deep muscles of lower
extremity for stroke patients. The aims of investigator's study were to compare the
effectiveness of BTX-A injection by different guidance methods (palpation of anatomical
landmarks, ultrasonography direct) in deep spastic muscles of lower extremity for stroke
patients with varus spasticity and spastic claw toes , and to study the correlation between
muscles spasticity and elastic properties by the sonoelastography/acoustic radiation force
impulse imaging and follow the change of elastic properties in spastic muscles after BTX-A
injection. We will enroll 80 hemiplegic stroke patients with varus spasticity / spastic claw
toes and duration more than 6 months. Under different guidance methods (palpation of
anatomical landmarks, electric stimulation, ultrasonography direct and indirect methods),
BTX-A will be injected to the flexor digitorum longus and posterior tibialis muscles. If the
patients have moderate hallucis spasticity, flexor hallucis longus muscle will be injected.
The BTX-A dose is 50 units for each muscle. Outcome measures include Modified Ashworth Scale,
Brunnstrom stage, muscle power, range of motion, the visual analog scale of pain, Stroke
Impact Scale, Barthel index and lower extremity function tests, balance test, Goal Attainment
Scale, sonoelastography and acoustic radiation force impulse imaging. All the assessments
will be performed before BTX-A injection and followed up at 1 months, 2 months, 3 months and
6 months after injection. After performing all the assessments, investigator will investigate
the efficiency of BTX-A by different guidance methods.
Phase:
Phase 3
Details
Lead Sponsor:
Chang Gung Memorial Hospital
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A incobotulinumtoxinA onabotulinumtoxinA