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