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

Stroke Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01817816
• Other study ID #: CCH-061203
• Status: Completed
• Phase: N/A
• First received: March 21, 2013
• Last updated: November 3, 2015
• Start date: January 2009
• Est. completion date: June 2015

Study information

• Verified date: November 2015
• Source: Changhua Christian Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Spasticity
• Stroke

Intervention

Procedure:
• Botox_A

• Botox_B

Locations

Country	Name	City	State
Taiwan	Changhua Christian Hospital	Taiwan	Changhua

Sponsors (1)

Lead Sponsor	Collaborator
Changhua Christian Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the muscle tone in upper and lower extremity	use modified Ashworth Scale to access elbow, wrist, ankle joint muscle tone 0: normal; slight hypertonus, at the end-range 1+: mild hypertonus, catch when limb is moved (<1/2); moderate hypertonus,, limbs moves easily (>1/2); passive movement difficult; rigid	4 weeks after injection	Yes
Secondary	Change in the gait pattern as walking		4 weeks after intervention	Yes