Early Injection of Botulinum Toxin on Motor Function and Gait Pattern in Stroke Patients

Completed

Phase N/A Results N/A

Trial Description

Spasticity, muscle weakness, abnormal gait pattern are co-morbidities commonly seen in stroke patients. They cause disabled condition of patients in activities of daily life and functional performance, and also accidental falls and subsequent fractures.
This study is to evaluate and compare the effects of different phase injection of Botulinum Toxin Type-A at affected limbs on muscle rheological changes, muscle activity, muscle tone, functional performance, gait pattern and energy consumption in stroke patients.

Conditions

Interventions

  • Botox_A Procedure
    ARM 1: Kind: Experimental
    Label: Botox_A
    Description: receiving Botulinum Toxin Type-A (Botox-A, Allergan) at both affected lower extremity (aLE) and upper extremity (aUE)
    ARM 2: Kind: Experimental
    Label: placebo_A
    Description: receiving placebo injection at both aLE & aUE ; receiving Botox-A at both aLE & aUE at 6-month.
  • Botox_B Procedure
    ARM 1: Kind: Experimental
    Label: Botox_B
    Description: receiving Botox-A injection at aLE and placebo injection (sterile normal saline) at aUE.
    ARM 2: Kind: Experimental
    Label: placebo_B
    Description: receiving placebo injection at both aLE & aUE ; receiving Botox-A only at aLE at 6-month.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Change in the muscle tone in upper and lower extremity 4 weeks after injection Yes
Secondary Change in the gait pattern as walking 4 weeks after intervention Yes

Sponsors