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Post Stroke Spastic HemiplegiaPhase 1NCT04630873

Low or High Botox Dilution for the Hemiplegic Gait?

A Phase 1 study testing Botulinum toxin and gait analysis in people with Post Stroke Spastic Hemiplegia, run by University of Ioannina at 1 site in Greece.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Post Stroke Spastic Hemiplegia
What is being tested?
Botulinum toxin and gait analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteGreece
Study dates
20 Nov 2020to 1 Aug 2025
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • patients suffering from any mental illness that would disturb the gait pattern
  • patients suffering from musculoskeletal diseases that overtly interfere with the gait

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Greece1 site, 1 recruiting

  • Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina

    Ioannina, 45100

    Avraam Ploumis, 6932080701, aploumis@uoi.gr

    Recruiting

Other trials in Greece

About this study

Official title: Different Dilutions and Efficacy of Botulin Toxin in the Correction of 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.

Read the 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.

Being tested
Botulinum toxin, gait analysis
Keywords
stroke, hemiplegia
Medical subject headings
Stroke, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum toxinDrug

    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 analysisDiagnostic test

    Also called medicapteurs Win-Track, RehaGait Pro

    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:

Study groups in NCT04630873
Study groupRoleWhat they receive
LOW-HIGH VOLUMEActive comparatorInitially 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.
Receives: Drug: Botulinum toxin; Diagnostic Test: gait analysis
HIGH-LOW VOLUMEExperimentalinitially 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.
Receives: Drug: Botulinum toxin; Diagnostic Test: gait analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of Ankle motion from baseline to 1 month postinjection

    range of motion of ankle during gait

    Measured: Day 1 (baseline) and at 1 month postinjection

  2. 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

    Measured: Day 1 (baseline) and at 1 month postinjection

  3. Change of standing balance from baseline to 1 month postinjection

    measuring the ground force position when standing

    Measured: Day 1 (baseline) and at 1 month postinjection

  4. Change of walking balance from baseline to 1 month postinjection

    measuring the ground force position when walking

    Measured: Day 1 (baseline) and at 1 month postinjection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2020
  2. Study start20 Nov 2020
  3. Primary completion1 Aug 2025 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Crossover
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 blind
Who is masked
Care provider, Investigator
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04630873
Sponsor's protocol ID
UIoannina 2
Status last verified
Dec 2024
First submitted
31 Oct 2020
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Francisco GE, Boake C, Vaughn A. Botulinum toxin in upper limb spasticity after acquired brain injury: a randomized trial comparing dilution techniques. Am J Phys Med Rehabil. 2002 May;81(5):355-63. doi: 10.1097/00002060-200205000-00007.

    PubMed 11964576

  • Lee LR, Chuang YC, Yang BJ, Hsu MJ, Liu YH. Botulinum toxin for lower limb spasticity in children with cerebral palsy: a single-blinded trial comparing dilution techniques. Am J Phys Med Rehabil. 2004 Oct;83(10):766-73. doi: 10.1097/01.phm.0000137314.38806.95.

    PubMed 15385785

  • Gracies JM, Lugassy M, Weisz DJ, Vecchio M, Flanagan S, Simpson DM. Botulinum toxin dilution and endplate targeting in spasticity: a double-blind controlled study. Arch Phys Med Rehabil. 2009 Jan;90(1):9-16.e2. doi: 10.1016/j.apmr.2008.04.030.

    PubMed 19154823

  • Shaari CM, Sanders I. Quantifying how location and dose of botulinum toxin injections affect muscle paralysis. Muscle Nerve. 1993 Sep;16(9):964-9. doi: 10.1002/mus.880160913.

    PubMed 8355728

  • Pearce LB, Borodic GE, First ER, MacCallum RD. Measurement of botulinum toxin activity: evaluation of the lethality assay. Toxicol Appl Pharmacol. 1994 Sep;128(1):69-77. doi: 10.1006/taap.1994.1181.

    PubMed 8079356

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Botulinum toxin and gait analysis in people with Post Stroke Spastic Hemiplegia, run by University of Ioannina at 1 site in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of Ankle motion from baseline to 1 month postinjection (time frame: Day 1 (baseline) and at 1 month postinjection). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04630873, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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