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Low or High Botox Dilution for the Hemiplegic Gait?

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ClinicalTrials.gov Identifier: NCT04630873
Recruitment Status : Recruiting
First Posted : November 16, 2020
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Avraam Ploumis, University of Ioannina

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Post Stroke Spastic Hemiplegia Drug: Botulinum toxin Diagnostic Test: gait analysis Phase 1

Detailed Description:

There is an ongoing controversy regarding the effect of different dilutions in the efficacy 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. They are arguing that BTX-A in high dilution is the optimal choice especially when bigger muscles are injected, for the large volume of fluid administered into the muscle will carry the BTX-A molecules to endplates remote from the injection site. Two animal studies suggest that increasing the volume of diluents is a potential strategy in order to achieve a more efficient and cost-effective manner of BTX-A treatment. An attempt to quantify how the location of BTX-A injection affects the drug effect was made, which revealed that injecting only 0.5 cm away from the motor endplates yielded a 50% decrease in paralysis2. A newer double-blinded study by JM Gracies et al performed on humans comes to the same conclusion, that high volume dilution provides greater neuromuscular block and spasticity reduction than a low volume dilution. 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.

Previous studies lack either the design or the power of study was low. Therefore, there is no clear guideline for an optimal botulinum toxin dilution protocol.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: In a sequential manner, every second patient that will meet our inclusion criteria will be treated with a low concentration of the drug during their first visit at our outpatient clinic. Then, after a safe washout period of 6 months, the same patients will be injected with a high concentration of the drug. The same procedure will be inversely performed in the other half of the patients.
Masking: Double (Care Provider, Investigator)
Masking Description: In a sequential manner, every second patient that will enter the protocol will be treated with one of the two (high or low) diluted drug and will be assigned a number. Neither the investigator nor the outcome assessor (who will read the gait parameters) will be aware of the dilution used in each case.
Primary Purpose: Treatment
Official Title: Different Dilutions and Efficacy of Botulin Toxin in the Correction of the Hemiplegic Gait
Actual Study Start Date : November 20, 2020
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : December 1, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: LOW-HIGH VOLUME
Initially a low volume of the drug (100IU botulinum toxin diluted in 2 ml) after a safe washout period of 6 months the same patients will be injected with a high volume (100IU botulinum toxin in 4 ml) of the drug.
 Drug: Botulinum toxin
The 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.

Diagnostic Test: gait analysis
The 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:
Other Names:
  • medicapteurs Win-Track
  • RehaGait Pro
Experimental: HIGH-LOW VOLUME
initially a high volume of the drug (100IU botulinum toxin diluted in 4 ml) after a safe washout period of 6 months the same patients will be injected with a low volume (100IU botulinum toxin in 2 ml) of the drug.
 Drug: Botulinum toxin
The 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.

Diagnostic Test: gait analysis
The 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:
Other Names:
  • medicapteurs Win-Track
  • RehaGait Pro


Outcome Measures
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Primary Outcome Measures :
  1. Change of Ankle motion from baseline to 1 month postinjection [ Time Frame: Day 1 (baseline) and at 1 month postinjection ]
    range of motion of ankle during gait

  2. Change of modifies Ashworth scale (from 0 to 4, higher grade means worse spasticity) of the ankle from baseline to 1 month postinjection [ Time Frame: Day 1 (baseline) and at 1 month postinjection ]
    spasticity measurement

  3. Change of standing balance from baseline to 1 month postinjection [ Time Frame: Day 1 (baseline) and at 1 month postinjection ]
    measuring the ground force position when standing

  4. Change of walking balance from baseline to 1 month postinjection [ Time Frame: Day 1 (baseline) and at 1 month postinjection ]
    measuring the ground force position when walking


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • equinovarus deformity
  • with an average 3 on Ashworth spasticity scale
  • able to walk indoors either freely or with a cane.

Exclusion Criteria:

  • patients suffering from any mental illness that would disturb the gait pattern
  • patients suffering from musculoskeletal diseases that overtly interfere with the gait
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04630873


Locations
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Greece
Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina Recruiting
Ioannina, Greece, 45100
Contact: Avraam Ploumis    6932080701    aploumis@uoi.gr   
Sponsors and Collaborators
University of Ioannina
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Avraam Ploumis, Professor of Physical Medicine and Rehabilitation, University of Ioannina
ClinicalTrials.gov Identifier: NCT04630873    
Other Study ID Numbers: UIoannina 2
First Posted: November 16, 2020    Key Record Dates
Last Update Posted: September 28, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Avraam Ploumis, University of Ioannina:
stroke
hemiplegia
Additional relevant MeSH terms:
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Hemiplegia
Gait Disorders, Neurologic
Nervous System Diseases
Neurologic Manifestations
Paralysis
Botulinum Toxins
 Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs