Clinical trial NCT02557737: Botulinim Toxin Type A Injections by Different Guidance in Stroke Patients With Spasticity on Upper Extremities
Official title: Comparison of Surface Landmark, Ultrasonography and Electric Stimulation Guidance for Botulinum Toxin Injections in Stroke Patients With Spasticity on Upper Extremities.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cerebrovascular Accident
Keywords: stroke
upper extremity
spasticity
botulinum toxin
ultrasonography
electric stimulation
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-09-23
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Modified Ashworth Scale
timeFrame: Change from Baseline Muscle Tone at 6 months
Secondary outcomes:
measure: Brunnstrome Stage
timeFrame: Change from Baseline Condition at 6 months
measure: Active Range of Motion
timeFrame: Change from Baseline Data at 6 months
measure: 4 Point Categorical Pain Intensity Scale
timeFrame: Change from Baseline Data at 6 months
measure: Hand-grasp strength Assessment
timeFrame: Change from Baseline Data at 6 months
measure: Pinch Strength Assessment
timeFrame: Change from Baseline Data at 6 months
measure: Barthel Index
timeFrame: Change from Baseline Data at 6 months
measure: Stroke Impact Scale (SIS)
timeFrame: Change from Baseline Data at 6 months
measure: Action Research Arm Test (ARAT)
timeFrame: Change from Baseline Data at 6 months
measure: Wolf Motor Function Test
timeFrame: Change from Baseline Data at 6 months
measure: Chedoke Arm and Hand Activity Inventory (CAHAI)
timeFrame: Change from Baseline Data at 6 months
measure: Fugl-Meyer Assessment
timeFrame: Change from Baseline Data at 6 months
measure: Motor Activity Log Scale
timeFrame: Change from Baseline Data at 6 months
measure: Nine Hole Peg Test
timeFrame: Change from Baseline Data at 6 months
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Rehabilitation
name: Pong Ya-Ping, MD
role: STUDY_CHAIR
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