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Comparison of Botulinum Toxin Injection Techniques in Spasticity

Comparison of the Efficacy of 2 Different Botulinum Toxin Injection Techniques in Gastrocnemius Muscle Spasticity in Hemiplegic Patients: A Randomized Double-blind Controlled Study.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05615987
Enrollment
60
Registered
2022-11-14
Start date
2022-12-01
Completion date
2023-10-01
Last updated
2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spastic Hemiplegia

Brief summary

The aim of the study is to compare the effectiveness of the classical (2-4 points to the muscle proximal) application of botulinum toxin in the treatment of spasticity with the application along the length of the gastrecnemius muscle. The main question it aims to answer Is botulinum toxin more effective in the treatment of spasticity than the classical application applied along the length of the gastrocnemius muscle? Participants will be evaluated for spasticity before and 1 month after injection. Researchers will compare classical versus application along the length of the muscle to see if there is a reduction in spasticity.

Interventions

200iu/2ml in both groups

Sponsors

Konya Beyhekim Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed with spastic hemiplegia * Spasticity in the gastrocnemius muscle

Exclusion criteria

* Those who have spasticity in other muscles that will affect ankle movements * Those who use myorelaxant or myospasm-effective drugs * Those who have been applied botulinum toxin in the last 3 months * Those who have contractures in the ankle and knee due to orthopedic reasons.

Design outcomes

Primary

MeasureTime frameDescription
Spasticity assessment (change between pre-injection and 1-month control)before injection and 1 month after injectionModified ashworth scale
ambulation level (change between pre-injection and 1-month control)before injection and 1 month after injectionfunctional ambulation scale
ambulation velocity (change between pre-injection and 1-month control)before injection and 1 month after injectionpreferred walking speed

Countries

Turkey (Türkiye)

Contacts

Primary ContactSavaş Karpuz, M.D.
svskrpz@hotmail.com+905552057860

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026