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

Not Applicable

Completed

• Conditions: Stroke; Spasticity
• Interventions: Procedure: Botox_A; Procedure: Botox_B

• Registration Number: NCT01817816
• Lead Sponsor: Changhua Christian Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2013-03-21
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-25
• Primary Completion: 2015-04
• Study Completion: 2015-06
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-03
• Last Update Posted: 2015-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Botox_A	Botox_A	receiving Botulinum Toxin Type-A (Botox-A, Allergan) at both affected lower extremity (aLE) and upper extremity (aUE)
placebo_B	Botox_B	receiving placebo injection at both aLE \& aUE ; receiving Botox-A only at aLE at 6-month.
placebo_A	Botox_A	receiving placebo injection at both aLE \& aUE ; receiving Botox-A at both aLE \& aUE at 6-month.
Botox_B	Botox_B	receiving Botox-A injection at aLE and placebo injection (sterile normal saline) at aUE.

Primary Outcome Measures

Name	Time	Method
Change in the muscle tone in upper and lower extremity	4 weeks after injection	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

Secondary Outcome Measures

Name	Time	Method
Change in the gait pattern as walking	4 weeks after intervention

Trial Locations

Locations (1)

Changhua Christian Hospital; 🇨🇳 Taiwan, Changhua, Taiwan