Low or High Botox Dilution for the Hemiplegic Gait?

NCT04630873 | Recruiting Phase 1 FDA Drug

• 1 other identifier: UIoannina 2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Stroke Spastic Hemiplegia

Keywords

stroke; hemiplegia

Outcome Measures

Primary Outcomes (4)

• Change of Ankle motion from baseline to 1 month postinjection

  range of motion of ankle during gait

  Day 1 (baseline) and at 1 month postinjection

• 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

  Day 1 (baseline) and at 1 month postinjection

• Change of standing balance from baseline to 1 month postinjection

  measuring the ground force position when standing

  Day 1 (baseline) and at 1 month postinjection

• Change of walking balance from baseline to 1 month postinjection

  measuring the ground force position when walking

  Day 1 (baseline) and at 1 month postinjection

Study Arms (2)

LOW-HIGH VOLUME

ACTIVE COMPARATOR

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; Diagnostic Test: gait analysis

HIGH-LOW VOLUME

EXPERIMENTAL

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; Diagnostic Test: gait analysis

Interventions

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.

HIGH-LOW VOLUME; LOW-HIGH VOLUME

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:

Also known as: medicapteurs Win-Track, RehaGait Pro

HIGH-LOW VOLUME; LOW-HIGH VOLUME

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Ioannina: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina

Ioannina, 45100, Greece

RECRUITING

Related Publications (5)

• 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.

  PMID: 11964576 BACKGROUND

• 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.

  PMID: 15385785 BACKGROUND

• 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.

  PMID: 19154823 RESULT

• 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.

  PMID: 8355728 RESULT

• 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.

  PMID: 8079356 RESULT

MeSH Terms

Conditions

Stroke; Hemiplegia

Interventions

Botulinum Toxins; Gait Analysis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Gait; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Functional Performance; Physical Fitness; Health; Population Characteristics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Medicine and Rehabilitation

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2020
• First Posted: November 16, 2020
• Study Start: November 20, 2020
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

GR (1)