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Clinical Trials/NCT01817816
NCT01817816
Completed
Not Applicable

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

Changhua Christian Hospital1 site in 1 country80 target enrollmentJanuary 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Changhua Christian Hospital
Enrollment
80
Locations
1
Primary Endpoint
Change in the muscle tone in upper and lower extremity
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2009
End Date
June 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ta-Sen Wei,MD

Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor

Changhua Christian Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in the muscle tone in upper and lower extremity

Time Frame: 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 Outcomes

  • Change in the gait pattern as walking(4 weeks after intervention)

Study Sites (1)

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