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

Chang Gung Medical Foundation

Status and phase: Unknown; Phase 3

Conditions: Cerebrovascular Accident

Treatments: Drug: Botulinum Toxin Type A

Study type: Interventional

Funder types: Other

Identifiers

NCT02557737

CMRPG8B0222

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Ultrasonography direct-guidance

Experimental group

Description:

To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance.

Treatment:

Drug: Botulinum Toxin Type A

Electric stimulation

Experimental group

Description:

To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Electric stimulation

Treatment:

Drug: Botulinum Toxin Type A

Surface anatomy landmark

Active Comparator group

Description:

To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Surface anatomy landmark.

Treatment:

Drug: Botulinum Toxin Type A