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

Not yet recruiting

Phase 3 Results N/A

Trial Description

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.

Detailed Description

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, electric stimulation, ultrasonography direct and indirect methods) 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.
Two of arms:
1. ultrasonography direct-guidance: To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance.
2. 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, 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 patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection No
Secondary activities of daily living patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection No
Secondary Berg Balance Test patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection No
Secondary Tinetti Gait Analysis patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection No
Secondary Mini-Mental State Examination patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection No
Secondary Stroke Impact Scale patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection No
Secondary Fugl-Meyer Assessment Score patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection No
Secondary Functional Ambulation Classification patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks and 1 year after injection No

Sponsors