AzTrials
AzTrials

StrokePhase 2/3STROKEPOCNCT06296082

Comparative Study of the Effects of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity

A Phase 2/3 study testing Botulinum toxin type A and Dry Needling in people with Stroke, run by Universiteit Antwerpen at 3 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a randomized parallel group clinical trial which will be conducted in three countries (Spain, Canada and Belgium) comparing Botulinum Toxin type A (BTX-A) and Dry Needling (DN) effectiveness for post-stroke spasticity in participants who had a first stroke in the previous 12 months and have plantar flexor… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stroke
What is being tested?
Botulinum toxin type A and Dry Needling
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
3 sitesin 3 countries
Study dates
1 Sep 2024to 29 Mar 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • aged 18-75 years.
  • post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2).
  • first stroke.
  • 0-12 months evolution.
  • no previous BTX-A or DN treatment for spasticity.
  • ankle passive range of motion ≥ 20° (approximately) with knee flexion ~30°.
  • independent ambulation with or without aids.

Who cannot join

  • medical conditions interfering with data interpretation.
  • contraindications for BTX-A or DN treatment.
  • changes in anti-spasticity medication dosage (if appropriate), either during the trial or within the 3 months prior to participation.
  • pregnant or breastfeeding.

Trial locations and contacts

3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Pablo Herrero Gallego, PhD contact

+34646168248

pherrero@unizar.es

Clara Pujol Fuentes, Msc contact

+34661075990

clara.pujol.fisioterapeuta@gmail.com

3 sites in 3 countries

Belgium1 site, 1 recruiting

  • Universiteit Antwerpen

    Antwerp, Flanders, 2000

    Wim Saeys, PT, +32496804347, wim.Saeys@uantwerpen.be

    Bart Eeckhaut, PT, +32486543747, eeckhautbart@hotmail.com

    Recruiting

Other trials in Belgium

Canada1 site, 1 recruiting

  • Jewish Rehabilitation Hospital

    Montreal, Quebec, H7V 1R2

    Mindy F. Levin, PT, +972505204734, mindy.levin@mcgill.ca

    Mindy F. Levin, PT

    Recruiting

Other trials in Canada

Spain1 site, 1 recruiting

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, Zaragoza, 50009

    Pablo Herrero Gallego, PT, +34646168248, pherrero@unizar.es

    Clara Pujol Fuentes, PT, +34661075990, clara.pujol.fisioterapeuta@gmail.com

    Recruiting

Other trials in Spain

About this study

Official title: Comparative Study of the Mechanism of Action of Dry Needling and Botulinum Toxin Type A as a Treatment for Lower Limb Post-stroke Spasticity: a Proof of Concept Controlled Trial

This is a randomized parallel group clinical trial which will be conducted in three countries (Spain, Canada and Belgium) comparing Botulinum Toxin type A (BTX-A) and Dry Needling (DN) effectiveness for post-stroke spasticity in participants who had a first stroke in the previous 12 months and have plantar flexor spasticity. Participants will be randomly allocated to receive either one session of BTX-A or 12 weekly sessions of DN. Blinded evaluators will assess the effects before, during, and after treatment, and at a 4-week follow-up.

Read the detailed description

The primary hypothesis is that the effects of DN on post-stroke spasticity in the lower limbs at the spinal level is comparable to BTX-A in reducing spasticity by decreasing stretch reflex excitability.

Sample size: Spain, Canada and Belgium will recruit 90 participants (30 per country)

The platform used for randomization and electronic data collection will be Research Electronic Data Capture (REDcap): https://www.project-redcap.org/. A shared license will be used among the countries involved in the study.

Data dictionary:

  • DN: Dry Needling
  • BTX-A: Botulinum toxin type A
  • TSRT: Tonic Stretch Reflex Threshold
  • MAS: Modified Ashworth Scale
  • 10MWT: 10 Metre Walk Test
  • TUG: Timed Up \& Go
  • PPI: Public and Patient Involvement
  • SOP: Standard Operating Procedure
Conditions
Stroke
Keywords
Stroke [Mesh], Dry Needling, Muscle Spasticity [Mesh], Botulinum Toxins [Mesh], Tonic Stretch Reflex Threshold, Ultrasound imaging, Gait analysis, Quality of Life [Mesh]
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Botulinum toxin type ADrug

    Botulinum toxin type A injections are a treatment technique to treat the spastic muscles in patients with stroke that targets on the neuromuscular endplate zone provoking a chimical disruption of dysfunctional endplates.

  • Dry NeedlingOther

    Dry Needling is a treatment technique to treat the spastic muscles in patients with stroke that targets on the neuromuscular endplate zone provoking a mechanical disruption of dysfunctional endplates.

Study groups in NCT06296082
Study groupRoleWhat they receive
Botulinum Toxin type AActive comparatorThe BTX-A group will receive onabotulinumtoxinA (Botox®, Allergan) with mandatory muscles getting 300 units and optional muscles getting up to 100 additional units (maximum dose of 400 units) (14) delivered with a 27-gauge (0.45 mm) beveled needle. Target muscles will be identified by ultrasound imaging or muscle stimulation. Local anesthesia will not be used. Patient positioning will be standardized.
Receives: Drug: Botulinum toxin type A
Dry NeedlingActive comparatorFor Dry Needling group solid, filiform non-beveled 0.30 mm caliber needles will be used. Target muscles will be identified by ultrasound imaging or muscle stimulation. Local anesthesia will not be used. Patient positioning will be standardized.
Receives: Other: Dry Needling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tonic Stretch Reflex Threshold (TSRT)

    TSRT is a novel measures of stretch reflex excitability that provide an indirect indicator of the excitability of α-motoneurons at the level of the spinal cord.

    Measured: Week 1 to 15 and 19.

Secondary outcomes (11)

  1. Muscle thickness

    It is the estimation of the thickness of the muscle fiber, which is obtained by tracing a line that covers the length of the muscle between the deep and superficial aponeuroses.

    Measured: Week 1 to 15 and 19.

  2. Pennation angle

    It is the angle between the deep fascia and the line of the fascicle length.

    Measured: Week 1 to 15 and 19.

  3. Concurrence matrices

    Measures that describe the spatial distribution of gray levels in the texture of an ultrasound image. These matrices, also known as co-occurrence matrices, are used to analyze textural features and patterns in ultrasound images.

    Measured: Week 1 to 15 and 19.

  4. Resistance to passive stretching

    It will be measured using the Modified Ashworth Scale (MAS). The scale ranges from a minimum value of 0 to a maximum of 4, with 0 indicating no spasticity (no resistance to passive stretching) and 4 representing the most severe spasticity (resistance to passive stretching), characterized by complete rigidity.

    Measured: Week 1 to 15 and 19.

  5. Gait analysis

    It will be done with motion capture systems using wearable and inertial sensors. Canada and Belgium: Xsens system (MVN Awinda, Movella, Hendersen, USA); Spain: Move Human Sensors MoCap System.

    Measured: Week 1,2,9,15 and 19

  6. Functional mobility

    Measured by Time Up and Go (TUG).

    Measured: Week 1,2,9,15 and 19

  7. Functional mobility

    Measured by 10 Meter Walk Test (10MWT)

    Measured: Week 1,2,9,15 and 19

  8. Muscle Strength

    Muscle strength will be measured by hand-held dynamometry (MicroFET 2)

    Measured: Week 1 to 15 and 19.

  9. Quality of life analysis

    It will be assessed with the EuroQOL-5D (Euro Quality of Life-5 Dimensions-5 Levels). Responses from the questionnaire will be converted to health-state utility values, where higher values represent improved quality of life. Index scores range from -0.59 to 1, where 1 is the best possible health state.

    Measured: Week 1, 15 and 19.

  10. Cost-effectiveness

    Costs related to treatment will be assessed by computing the ICER (Incremental cost-effectiveness ratio) in €/QALY (Quality-Adjusted Life Year)

    Measured: Week 19.

  11. Safety: Frequency and severity of Dry Needling (DN) and Botulinum Toxin type A (BTX-A) adverse events

    Description of the adverse events

    Measured: Week 3 to 14 and 19.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2024
  2. Study start1 Sep 2024
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion29 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A prospective randomized, controlled, multiple-baseline, and assessor blinded multicenter equivalence trial with two parallel groups.
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06296082
Sponsor's protocol ID
49317
Acronym
STROKEPOC
Status last verified
Apr 2026
First submitted
13 Feb 2024
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data (IPD) will be shared with other researchers in accordance with data sharing protocols and participant consent, ensuring confidentiality and ethical considerations are maintained.

Publications

  • Pujol-Fuentes C, Eeckhaut B, Fernandez Carnero S, Fernandez Sanchis D, Wein T, Herrero P, Saeys W, Levin MF. Spinal mechanisms and feasibility of Dry Needling versus Botulinum Toxin Type A in post-stroke lower limb spasticity: A proof-of-concept randomized clinical trial protocol (STROKE-POC). PLoS One. 2026 May 20;21(5):e0334571. doi: 10.1371/journal.pone.0334571. eCollection 2026.

    PubMed 42160369

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Botulinum toxin type A and Dry Needling in people with Stroke, run by Universiteit Antwerpen at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium, Canada, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Pablo Herrero Gallego, PhD (+34646168248, pherrero@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tonic Stretch Reflex Threshold (TSRT) (time frame: Week 1 to 15 and 19.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06296082, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in