protocolSection identificationModule nctId: NCT06296082, orgStudyIdInfo id: 49317, briefTitle: 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, acronym: STROKEPOC, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-01, primaryCompletionDateStruct date: 2026-03-31, completionDateStruct date: 2027-06-30, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Universiteit Antwerpen, class: OTHER, collaborators name: McGill University, collaborators name: Aragon Institute of Health Sciences, descriptionModule briefSummary: Trial design This study is a protocol of a phase II clinical trial which will be conducted in two countries (Belgium and Spain) to compare the effectiveness of DN and BTX A in reducing post-stroke spasticity in the plantar flexor muscles. This study is a prospective randomized, controlled, multiple-baseline design with blinded assessors. The study will be registered in ClinicalTrials.gov and will have a length of 19 weeksTrial population Inclusion Criteria: 1) aged 18-75 years old, 2) having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2); 3) having had a first stroke; 4) having no more than 12 months of evolution since stroke; 5) having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity; 6) having ankle PROM ≥ 20° (approx.) when the knee is supported in \~30° flexion; 7) being able to walk independently with or without aids.Exclusion Criteria: 1) medical conditions interfering with data interpretation; 2) any contraindication to receiving BTX A or PS treatment; 3) If taking anti-spasticity medications, participants must be on stable medication for at least 3 months prior to the start of the study and neither the dose nor the medication can be changed during the tria Interventions Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Blinded evaluators will assess the effects before, during, after treatment, and at 4-week follow-up.The trial will have regular monitoring visits by an independent external monitor to ensure compliance with the protocol and Good Clinical Practices. Monitors may review source documents to confirm accurate data on CRD. The investigator and institution will guarantee direct access to source documents for monitors and regulatory authorities., conditionsModule conditions: Stroke, conditions: Spasticity as Sequela of Stroke, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly allocated to the group receiving a session of BTX A or to the group receiving Dry Needling once weekly for 12 weeks. Each group will be assessed equally during the 19 weeks of the study duration., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Participant will be randomized but ultimately will know which treatment he/she receives. A distinct investigator/assessor and intervention therapist wil be selected to treat or assess the participant, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Botulinum toxin type A, interventions name: Dry Needling, outcomesModule primaryOutcomes measure: tonic stretch reflex threshold, secondaryOutcomes measure: Passive Resistance, secondaryOutcomes measure: Ultrasound Imaging: Morphometric Analysis, secondaryOutcomes measure: Ultrasound Imaging: Eco-textural Analysis of Muscle:, secondaryOutcomes measure: Dynamometry, secondaryOutcomes measure: Gait Analysis, secondaryOutcomes measure: 10 Meter Walk Test (10MWT), secondaryOutcomes measure: Timed up and Go Assessment (TUG), secondaryOutcomes measure: Quality of Life EuroQoL 5D, secondaryOutcomes measure: EQ visual analogue scale (EQ VAS), secondaryOutcomes measure: Cost-effectiveness, secondaryOutcomes measure: Patient Acceptance, otherOutcomes measure: Frequency and Severity of Adverse Events for DN and BTX A, otherOutcomes measure: Sample size, otherOutcomes measure: Sample size and drop out, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False