Recruiting
Phase 2
Phase 3

Dry Needling & Botulinum Toxin

Sponsor:

Universiteit Antwerpen

Code:

NCT06296082

Conditions

Stroke

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Botulinum toxin type A

Dry Needling

Study Details

Brief 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 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.

Conditions

Stroke

Study ID

NCT06296082

Start date

Sep 1, 2024

Status verified date

Apr, 2026

Completion date

Mar 29, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. aged 18-75 years.
2. post-stroke spasticity in ankle plantar flexors (Modified Ashworth Scale (MAS) scores of 1-2).
3. first stroke.
4. 0-12 months evolution.
5. no previous BTX-A or DN treatment for spasticity.
6. ankle passive range of motion ≥ 20° (approximately) with knee flexion \~30°.
7. independent ambulation with or without aids.

Exclusion Criteria:

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

Study Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Botulinum Toxin type A

The 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.

active comparator: Dry Needling

For 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.

Interventions

Botulinum toxin type A

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 Needling

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.

Primary outcome measure

  • Tonic Stretch Reflex Threshold (TSRT) [ Time Frame: Week 1 to 15 and 19. ]

Central Contacts and Locations

Central contacts

Pablo Herrero Gallego, PhD

+34646168248pherrero@unizar.es

Clara Pujol Fuentes, Msc

+34661075990clara.pujol.fisioterapeuta@gmail.com

Locations

Jewish Rehabilitation Hospital

Recruiting

Montreal, Quebec, Canada, H7V 1R2

Contacts

Mindy F. Levin, PT

+972505204734mindy.levin@mcgill.ca

Principal Investigator:

Mindy F. Levin, PT

More Information

Sponsor

Universiteit Antwerpen

Last update posted

May 4, 2026

Last verified

Apr, 2026

Keywords

  • Stroke [Mesh]
  • Dry Needling
  • Muscle Spasticity [Mesh]
  • Botulinum Toxins [Mesh]
  • Tonic Stretch Reflex Threshold
  • Ultrasound imaging
  • Gait analysis
  • Quality of Life [Mesh]

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Universiteit Antwerpen on 2026-05-04.