STROKE-POC

Phase 1

Conditions: Spasticity after Stroke
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutics [E02]
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Therapeutic area: Phenomena and Processes [G] - Musculoskeletal and Neural Physiological Phenomena [G11]

Registration Number: CTIS2024-510866-18-00

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

aged 18-85 years old, having lower limb post-stroke spasticity in ankle plantar flexors (MAS scores of 1, 1+ and 2);, having had a first stroke, 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, having ankle PROM = 20° (approx.) when the knee is supported in ~30° flexion, being able to walk independently with or without aids, having no previous Dry Needling (DN) or Botulinum Toxin type A (BTX A) treatment for spasticity

Exclusion Criteria

medical conditions interfering with data interpretation, any contraindication to receiving BTX A or PS treatment, 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 trial, Pregnancy and/or Breastfeeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To understand the effects that BTX A and Dry Needling have on post-stroke spasticity in the lower limbs at the spinal level;Secondary Objective: to assess their safety, feasibility, muscle and functional level effects, quality of life, and cost-effectiveness;Primary end point(s): Spasticity: it will be measured with the Tonic Stretch Reflex Threshold and its velocity sensitivity. It will be assessed weekly during 15 weeks (in week 3, two assessments will be conducted- one before the treatment and one after) and on the 19th week

Secondary Outcome Measures