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RECRUITING
NCT06296082
PHASE2/PHASE3

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

Sponsor: Universiteit Antwerpen

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2024-09-01

Completion Date

2025-12-31

Last Updated

2025-02-20

Healthy Volunteers

No

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.

Locations (3)

Universiteit Antwerpen

Antwerp, Flanders, Belgium

Jewish Rehabilitation Hospital

Montreal, Quebec, Canada

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Zaragoza, Spain