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New treatment option for Stroke
Official title Pilot Study on Muscle, Tendon, and Neural Changes Post-Botulinum Toxin Injections in Post-stroke Spastic Equinovarus
ClinicalTrials.gov ID: NCT06767631
What this study is testing
- What it's testing
- Poststroke spasticity significantly impairs function, particularly through the development of pes equinovarus. Botulinum toxin A (BoNT) injections into the medial gastrocnemius (MG) are a first-line treatment.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 60
You may be able to join if
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- 2\. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- 3\. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1%...
- 4\. Pes equinovarus due to spasticity
- 5\. Clinical need for BoNT injection at the lower leg
You likely can't join if
- Musculoskeletal or other neurological problems affecting the lower limb
- Presence of spinal cord pathology that could lead to spasticity, ataxia, dystonia
- Cognitive problems that impede measurements
- Severe co-morbidities
- Irritated skin or open wounds where ultrasound will be placed
- Pregnancy
See the full eligibility criteria
- Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
- 2\. At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- 3\. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants...
- 4\. Pes equinovarus due to spasticity
- 5\. Clinical need for BoNT injection at the lower leg
- 6\. Any previous injection of BoNT into the muscles to be investigated was at least 3 months ago
- 7\. First-ever, unilateral stroke
- Musculoskeletal or other neurological problems affecting the lower limb
- Presence of spinal cord pathology that could lead to spasticity, ataxia, dystonia
- Cognitive problems that impede measurements
- Severe co-morbidities
- Irritated skin or open wounds where ultrasound will be placed
- Pregnancy
- Profound atrophy of the muscles in the target area(s) of injection
- Participation in an treatment Trial with an investigational medicinal product (IMP) or device
- The effect of botulinum toxin A can theoretically be potentiated by agents affecting neuromuscular transmission, such as aminoglycoside antibiotics (e.g., gentamicin, tobramycin), lithium salts, cholinesterase...
The study team makes the final eligibility decision.
Where it's taking place
- Leuven, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leuven, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.