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NCT Number: NCT04630873

Low or High Botox Dilution for the Hemiplegic Gait?

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.

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Key information

Conditions

Post Stroke Spastic Hemiplegia Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina

Ioannina, 45100, Greece

Location status: Recruiting

Location contact

Avraam Ploumis

CONTACT

[email protected]

6932080701

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botulinum toxin

Drug

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.

Gait Analysis

Diagnostic Test

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Official study title

Different Dilutions and Efficacy of Botulin Toxin in the Correction of the Hemiplegic Gait

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Nov 16, 2020
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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