Lower Limb Spasticity After Stroke
Conditions
Keywords
poststroke spasticity, lower limb, botulinum toxin, A2
Brief summary
To test the safety and efficacy of a new generation botulinum toxin preparation A2NTX for treating stroke patients with lower limb spasticity. * we study the degree of spasticity in the ankle and knee joints, and walking speed in 30 patients with stroke before and after injecting 300 units of BOTOX or A2NTX in a blinded manner as for the patient, the physician, and the examiner. * we also assess the safety of A2NTX and compare it to that of BOTOX.
Interventions
DRUGA2NTX
Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
DRUGBOTOX
Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
Sponsors
Ministry of Health, Labour and Welfare, Japan
University of Tokushima
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* patients with lower limb spasticity after stroke * duration more than 6 months * Modified Ashworth Scale of ankle joint more than 2
Exclusion criteria
* patients with previous botulinum toxin injections to lower limbs * patients with serious hepatic, renal or cardiac dysfunction * patients with respiratory failure * patients who cannot understand the instructions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Ashworth Scale of the ankle joint | 30-60 days after injection | Modified Ashworth Scale is measured at baseline, 30(27-33) days and 60 (56-63) days after injection. Area under curve of Modified Ashworth Scale changes at day 30 and day 60 after injection |
Secondary
| Measure | Time frame |
|---|---|
| Change in Functional Independence Measure (FIM) | 30 days after injection |
Other
| Measure | Time frame | Description |
|---|---|---|
| Walking Speed for 3m | 30 days after injection | Time required for a patient to stand up from sitting position in a chair of 50cm height and walk for 3m. If assistance is needed, the same method of assisting the patient is used throughout the study. |
| grasp power | 30 days after injection | Grasping power of both upper limbs will be measure with a standard grasp measure device in kg units. Because injection is made into lower limbs, any decrease of grasp power will be assessed as the measure of unwanted spread of the toxin action. |
Countries
Japan
Outcome results
None listed