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Low or High Botox Dilution for the Hemiplegic Gait?

Primary Purpose

Post Stroke Spastic Hemiplegia

Status
Recruiting
Phase
Phase 1
Locations
Greece
Study Type
Interventional
Intervention
Botulinum toxin
gait analysis
Sponsored by
University of Ioannina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Stroke Spastic Hemiplegia focused on measuring stroke, hemiplegia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

LOW-HIGH VOLUME

HIGH-LOW VOLUME

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of Ankle motion from baseline to 1 month postinjection
range of motion of ankle during gait
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
Change of standing balance from baseline to 1 month postinjection
measuring the ground force position when standing
Change of walking balance from baseline to 1 month postinjection
measuring the ground force position when walking

Secondary Outcome Measures

Full Information

First Posted
October 31, 2020
Last Updated
March 1, 2023
Sponsor
University of Ioannina
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1. Study Identification

Unique Protocol Identification Number
NCT04630873
Brief Title
Low or High Botox Dilution for the Hemiplegic Gait?
Official Title
Different Dilutions and Efficacy of Botulin Toxin in the Correction of the Hemiplegic Gait
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ioannina

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Stroke Spastic Hemiplegia
Keywords
stroke, hemiplegia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
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
Care ProviderInvestigator
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.
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LOW-HIGH VOLUME
Arm Type
Active Comparator
Arm Description
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.
Arm Title
HIGH-LOW VOLUME
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
gait analysis
Other Intervention Name(s)
medicapteurs Win-Track, RehaGait Pro
Intervention Description
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:
Primary Outcome Measure Information:
Title
Change of Ankle motion from baseline to 1 month postinjection
Description
range of motion of ankle during gait
Time Frame
Day 1 (baseline) and at 1 month postinjection
Title
Change of modifies Ashworth scale (from 0 to 4, higher grade means worse spasticity) of the ankle from baseline to 1 month postinjection
Description
spasticity measurement
Time Frame
Day 1 (baseline) and at 1 month postinjection
Title
Change of standing balance from baseline to 1 month postinjection
Description
measuring the ground force position when standing
Time Frame
Day 1 (baseline) and at 1 month postinjection
Title
Change of walking balance from baseline to 1 month postinjection
Description
measuring the ground force position when walking
Time Frame
Day 1 (baseline) and at 1 month postinjection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina
City
Ioannina
ZIP/Postal Code
45100
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Avraam Ploumis
Phone
6932080701
Email
aploumis@uoi.gr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
11964576
Citation
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.
Results Reference
background
PubMed Identifier
15385785
Citation
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.
Results Reference
background
PubMed Identifier
19154823
Citation
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.
Results Reference
result
PubMed Identifier
8355728
Citation
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.
Results Reference
result
PubMed Identifier
8079356
Citation
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.
Results Reference
result

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Low or High Botox Dilution for the Hemiplegic Gait?

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