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

April 28, 2026 updated by: Dr. Pablo Herrero Gallego, Universiteit Antwerpen

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Flanders
      • Antwerp, Flanders, Belgium, 2000
        • Recruiting
        • Universiteit Antwerpen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wim Saeys, PT
        • Sub-Investigator:
          • Bart Eeckhaut, PT
  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H7V 1R2
        • Recruiting
        • Jewish Rehabilitation Hospital
        • Contact:
        • Principal Investigator:
          • Mindy F. Levin, PT
  • Spain
    • Zaragoza
      • Zaragoza, Zaragoza, Spain, 50009
        • Recruiting
        • Hospital Clinico Universitario Lozano Blesa
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pablo Herrero Gallego, PT
        • Sub-Investigator:
          • Clara Pujol Fuentes, PT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: 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.
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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tonic Stretch Reflex Threshold (TSRT)
Time Frame: Week 1 to 15 and 19.
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.
Week 1 to 15 and 19.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pennation angle
Time Frame: Week 1 to 15 and 19.
It is the angle between the deep fascia and the line of the fascicle length.
Week 1 to 15 and 19.
Concurrence matrices
Time Frame: Week 1 to 15 and 19.
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.
Week 1 to 15 and 19.
Gait analysis
Time Frame: Week 1,2,9,15 and 19
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.
Week 1,2,9,15 and 19
Quality of life analysis
Time Frame: Week 1, 15 and 19.
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.
Week 1, 15 and 19.
Cost-effectiveness
Time Frame: Week 19.
Costs related to treatment will be assessed by computing the ICER (Incremental cost-effectiveness ratio) in €/QALY (Quality-Adjusted Life Year)
Week 19.
Muscle thickness
Time Frame: Week 1 to 15 and 19.
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.
Week 1 to 15 and 19.
Resistance to passive stretching
Time Frame: Week 1 to 15 and 19.
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.
Week 1 to 15 and 19.
Functional mobility
Time Frame: Week 1,2,9,15 and 19
Measured by Time Up and Go (TUG).
Week 1,2,9,15 and 19
Functional mobility
Time Frame: Week 1,2,9,15 and 19
Measured by 10 Meter Walk Test (10MWT)
Week 1,2,9,15 and 19
Muscle Strength
Time Frame: Week 1 to 15 and 19.
Muscle strength will be measured by hand-held dynamometry (MicroFET 2)
Week 1 to 15 and 19.
Safety: Frequency and severity of Dry Needling (DN) and Botulinum Toxin type A (BTX-A) adverse events
Time Frame: Week 3 to 14 and 19.
Description of the adverse events
Week 3 to 14 and 19.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency and Severity of Adverse Events for DN and BTX A
Time Frame: At the end of the study: After week 19
Frequency and Severity of Adverse Events for DN and BTX A during or after the intervention
At the end of the study: After week 19
Sample size
Time Frame: At the end of the study: After week 19
Estimates for Sample Size Calculation and Recruitment and Consent Rates: These will be measured in the two participating countries to identify determining factors.
At the end of the study: After week 19
Sample size and drop out
Time Frame: At the end of the study: After week 19
The dropout rate during treatment and follow-up for each group (PS and BTX A) will be analyzed.
At the end of the study: After week 19

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiteit Antwerpen

Collaborators

McGill University
Instituto de Salud Carlos III
Fonds de la Recherche en Santé du Québec
Research Foundation Flanders
Instituto de Investigación Sanitaria Aragón

Investigators

  • Principal Investigator: Pablo Herrero Gallego, PhD, Universidad de Zaragoza

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

March 29, 2027

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 4, 2026

Last Update Submitted That Met QC Criteria

April 28, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 49317

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data will be available for 15 years.

IPD Sharing Access Criteria

In relation to other academic institutions and in the possession of a Good Clinical Practice Certificate

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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