Cerebrovascular Accident Clinical Trial
Official title:
Comparison of Surface Landmark, Ultrasonography and Electric Stimulation Guidance for Botulinum Toxin Injections in Stroke Patients With Spasticity on Upper Extremities.
The aims of this study were to compare the injection locations of key spastic muscles on upper extremity by three different guidance localization methods ( surface anatomy landmark, ultrasonography, electric stimulation) and the effectiveness.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - first onset. - at least onset before 6 months. - elbow, wrist and fingers are above Modified Ashworth Scale(MAS) 1+. - Mini-Mental State Exam above 24. - can follow all of the follow up and instruction. - patients never accept botox, phenol and alcohol injections before. Exclusion Criteria: - contracture deformity on upper extremity. - patients had accepted botox before or had have phenol, alcohol injections and operation 6 months ago. - allergy to botox. - have neither infection nor skin disorder on inject site. - now accept aminoglycoside or other medicine treatment which may affect neuromuscular transition. - combine other systemic disease of neurological or skelectomuscular system - cognition disorder or aphasia after stroke. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Modified Ashworth Scale | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Muscle Tone at 6 months | No |
Secondary | Brunnstrome Stage | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Condition at 6 months | No |
Secondary | Active Range of Motion | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | No |
Secondary | 4 Point Categorical Pain Intensity Scale | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | No |
Secondary | Hand-grasp strength Assessment | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | No |
Secondary | Pinch Strength Assessment | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | No |
Secondary | Barthel Index | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | No |
Secondary | Stroke Impact Scale (SIS) | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | No |
Secondary | Action Research Arm Test (ARAT) | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | No |
Secondary | Wolf Motor Function Test | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | No |
Secondary | Chedoke Arm and Hand Activity Inventory (CAHAI) | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | No |
Secondary | Fugl-Meyer Assessment | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | No |
Secondary | Motor Activity Log Scale | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | No |
Secondary | Nine Hole Peg Test | patients will be evaluated at 4 weeks, 8 weeks, 12 weeks, 24 weeks after injection | Change from Baseline Data at 6 months | No |
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