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

Changhua Christian Hospital80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke Spasticity

Interventions

Botox_APROCEDURE

Botox_BPROCEDURE

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * first-ever stroke, with spasticity within 3-months (MAS=2\~3) * independent walking 10 meters (with assistive devices) Exclusion Criteria: * recurrent stroke, cognition impaired * lower limb fracture * received anti-spasticity injection in the past

Locations (1)

Changhua Christian Hospital

Dawan, Changhua, Taiwan

Outcomes

Primary Outcomes

Change in the muscle tone in upper and lower extremity

use modified Ashworth Scale to access elbow, wrist, ankle joint muscle tone 0: normal 1. slight hypertonus, at the end-range 1+: mild hypertonus, catch when limb is moved (\<1/2) 2. moderate hypertonus,, limbs moves easily (\>1/2) 3. passive movement difficult 4. rigid

Time frame: 4 weeks after injection

Secondary Outcomes

Change in the gait pattern as walking

Time frame: 4 weeks after intervention

Data from ClinicalTrials.gov

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