Comparing low and high Botox dilution for improving walking after stroke
Different Dilutions and Efficacy of Botulin Toxin in the Correction of the Hemiplegic Gait
PHASE1 · University of Ioannina · NCT04630873
This study is testing whether using highly diluted Botox injections can help improve walking in people who have had a stroke better than using lower dilutions.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Ioannina (other) |
| Locations | 1 site (Ioannina) |
| Trial ID | NCT04630873 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of different dilutions of Botulin toxin type A (BTX-A) injections on gait improvement in patients with post-stroke spastic hemiplegia. It aims to determine whether highly diluted BTX-A injections provide a greater reduction in spasticity compared to lower dilutions. The study employs a crossover design, allowing participants to receive both treatment types, with gait analysis used to evaluate outcomes. This research addresses a significant gap in existing literature regarding optimal botulinum toxin dilution protocols.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with equinovarus deformity and an average spasticity score of 3 on the Ashworth scale who can walk indoors with or without assistance.
Not a fit: Patients with mental illnesses that affect gait patterns or musculoskeletal diseases that interfere with walking may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment protocols for improving gait in stroke survivors with spastic hemiplegia.
How similar studies have performed: While there is ongoing debate regarding the efficacy of different BTX-A dilutions, this specific crossover study design has not been previously performed, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ioannina
- Department of Physical Medicine and Rehabilitation, University Hospital of Ioannina — Ioannina, Greece (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post Stroke Spastic Hemiplegia, stroke, hemiplegia