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

NCT06296082 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-05-04

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Instituto de Investigación Sanitaria Aragón

    collaborator OTHER

  • McGill University

    collaborator OTHER

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Fonds de la Recherche en Santé du Québec

    collaborator OTHER_GOV

  • Research Foundation Flanders

    collaborator OTHER

  • Universiteit Antwerpen

    lead OTHER

Principal Investigators

  • Pablo Herrero Gallego, PhD · Universidad de Zaragoza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-12-30
Completion
2027-03-29
FDA Drug
Yes

Countries

  • Belgium
  • Canada
  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06296082 on ClinicalTrials.gov