Authorised Therapeutic exploratory (Phase II) Spasticity after Stroke

STROKE-POC

EU CTIS ID: 2024-510866-18-00

What this study is testing

To understand the effects that BTX A and Dry Needling have on post-stroke spasticity in the lower limbs at the spinal level

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • aged 18-85 years old
  • having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2);
  • having had a first stroke
  • having no more than 12 months of evolution since stroke; 5) having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity
  • having ankle PROM ≥ 20° (approx.) when the knee is supported in ~30° flexion
  • being able to walk independently with or without aids

You likely can't join if

  • medical conditions interfering with data interpretation
  • any contraindication to receiving BTX A or PS treatment
  • If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the trial
  • Pregnancy and/or Breastfeeding
See the full eligibility criteria
Who can join
  • aged 18-85 years old
  • having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2);
  • having had a first stroke
  • having no more than 12 months of evolution since stroke; 5) having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity
  • having ankle PROM ≥ 20° (approx.) when the knee is supported in ~30° flexion
  • being able to walk independently with or without aids
  • having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity
What rules you out
  • medical conditions interfering with data interpretation
  • any contraindication to receiving BTX A or PS treatment
  • If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the trial
  • Pregnancy and/or Breastfeeding

The study team makes the final eligibility decision.

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, 65+ years, 18-64 years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.