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

Changhua Christian Medical Foundation

Status: Completed

Conditions: Spasticity; Stroke

Treatments: Procedure: Botox_B; Procedure: Botox_A

Study type: Interventional

Funder types: Other

Identifiers

NCT01817816

CCH-061203

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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80 participants in 4 patient groups, including a placebo group

Botox_A

Experimental group

Description:

receiving Botulinum Toxin Type-A (Botox-A, Allergan) at both affected lower extremity (aLE) and upper extremity (aUE)

Treatment:

Procedure: Botox_A

placebo_A

Placebo Comparator group

Description:

receiving placebo injection at both aLE \& aUE ; receiving Botox-A at both aLE \& aUE at 6-month.

Treatment:

Procedure: Botox_A

Botox_B

Experimental group

Description:

receiving Botox-A injection at aLE and placebo injection (sterile normal saline) at aUE.

Treatment:

Procedure: Botox_B

placebo_B

Placebo Comparator group

Description:

receiving placebo injection at both aLE \& aUE ; receiving Botox-A only at aLE at 6-month.

Treatment:

Procedure: Botox_B