Stroke Clinical Trial
Verified date | November 2015 |
Source | Changhua Christian Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Institutional Review Board |
Study type | Interventional |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Changhua Christian Hospital | Taiwan | Changhua |
Lead Sponsor | Collaborator |
---|---|
Changhua Christian Hospital |
Taiwan,
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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