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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01817816
Other study ID # CCH-061203
Secondary ID
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


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
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