Low or High Botox Dilution for the Hemiplegic Gait?
ConditionPost Stroke Spastic Hemiplegia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Ioannina
About this trial
There is debate regarding the efficiency of different dilutions of Botulin toxin type A (BTX-A) injections. Some authors believe that highly diluted BTX-A injections achieve greater neuromuscular blockade resulting in higher spasticity reduction. On the other hand, other researchers suggest that there is no difference in spasticity decrease if either high or low volume toxin is being injected. Studies on this subject lack either the design or the power of study was low. Therefore, there is no clear guideline for an optimal botulinum toxin dilution protocol. In an attempt to have a better understanding, a cross over study was designed. The material will be patients with spastic hemiparesis which will be treated with Botulin toxin at different dilutions. Gait analysis will be used for the evaluation of the Botulin toxin injection on gait improvement. To the best of our knowledge such a trial hasn't been performed yet.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
equinovarus deformity
with an average 3 on Ashworth spasticity scale
able to walk indoors either freely or with a cane.
Disqualifiers
patients suffering from any mental illness that would disturb the gait pattern
patients suffering from musculoskeletal diseases that overtly interfere with the gait
Trial design
Design model
Crossover
Treatments tested in this trial
Botulinum toxin
DrugThe triceps surae along with the posterior tibialis muscle will be injected. The units that will be injected are the average being injected in our University Clinic. I.e. 50 units for each head of the gastrocnemius muscle- single injection site, 100 units for the soleus muscle- two injection sites and 50 units for the posterior tibialis muscle- single injection site.
gait analysis
Diagnostic testThe gait analysis will be performed with two systems. A foot pressure sensitivity walkway (medicapteurs Win-Track), and an IMU network system (RehaGait Pro) using seven IMU's placed in specific anatomical positions. In combination those two systems can provide a wide range of spatiotemporal analytics of gait:
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: LOW-HIGH VOLUMEActive comparator 2 interventions
Group B: HIGH-LOW VOLUMEExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change of Ankle motion from baseline to 1 month postinjection
range of motion of ankle during gait
Time frame
Day 1 (baseline) and at 1 month postinjection2
Change of modifies Ashworth scale (from 0 to 4, higher grade means worse spasticity) of the ankle from baseline to 1 month postinjection
spasticity measurement
Time frame
Day 1 (baseline) and at 1 month postinjection3
Change of standing balance from baseline to 1 month postinjection
measuring the ground force position when standing
Time frame
Day 1 (baseline) and at 1 month postinjection4
Change of walking balance from baseline to 1 month postinjection
measuring the ground force position when walking
Time frame
Day 1 (baseline) and at 1 month postinjectionSponsors and contacts
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Source ClinicalTrials.gov