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

Recruiting

Phase 3 Results N/A

Trial Description

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.

Conditions

Interventions

  • Botulinum toxin type A Biological
    Other Names: BOTOX®
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Ultrasonography direct-guidance
    Description: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance.
    ARM 2: Kind: Experimental
    Label: Electric stimulation
    Description: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Electric stimulation
    ARM 3: Kind: Experimental
    Label: Surface anatomy landmark
    Description: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Surface anatomy landmark.
    ARM 4: Kind: Experimental
    Label: Ultrasonography indirect-guidance
    Description: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography indirect-guidance.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Modified Ashworth Scale Change from Baseline Muscle Tone at 6 months No
Secondary Brunnstrome Stage Change from Baseline Condition at 6 months No
Secondary Active Range of Motion Change from Baseline Data at 6 months No
Secondary 4 Point Categorical Pain Intensity Scale Change from Baseline Data at 6 months No
Secondary Hand-grasp strength Assessment Change from Baseline Data at 6 months No
Secondary Pinch Strength Assessment Change from Baseline Data at 6 months No
Secondary Barthel Index Change from Baseline Data at 6 months No
Secondary Stroke Impact Scale (SIS) Change from Baseline Data at 6 months No
Secondary Action Research Arm Test (ARAT) Change from Baseline Data at 6 months No
Secondary Wolf Motor Function Test Change from Baseline Data at 6 months No
Secondary Chedoke Arm and Hand Activity Inventory (CAHAI) Change from Baseline Data at 6 months No
Secondary Fugl-Meyer Assessment Change from Baseline Data at 6 months No
Secondary Motor Activity Log Scale Change from Baseline Data at 6 months No
Secondary Nine Hole Peg Test Change from Baseline Data at 6 months No

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