Botulinum toxin type A for Post-stroke spasticity

Inclusion criteria

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

Exclusion criteria

• {"criterion_text":"- medical conditions interfering with data interpretation"}
• {"criterion_text":"- any contraindication to receiving BTX A or PS treatment"}
• {"criterion_text":"- 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"}
• {"criterion_text":"- Pregnancy and/or Breastfeeding"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Measured with the Tonic Stretch Reflex Threshold and its velocity sensitivity; assessments weekly for 15 weeks (week 3: two assessments, before and after treatment) and at week 19."}

Secondary endpoints

• {"endpoint_text":"- Resistance to passive stretching: measured with the Modified Ashworth Scale (MAS) It will be assessed weekly during 15 weeks and on the 19th week (in week 3, two assessments will be conducted- one before the treatment and one after).","definition_or_measurement_approach":"Measured with the Modified Ashworth Scale (MAS); assessments weekly for 15 weeks and at week 19 (week 3: two assessments, before and after treatment)."}
• {"endpoint_text":"- Gait: measured with instrumented gait analysis and the 10 Meter Walk Test (10MWT). It will be assessed on week 1, 2, 9, 15 and 19","definition_or_measurement_approach":"Measured using instrumented gait analysis and 10 Meter Walk Test (10MWT); assessed at weeks 1, 2, 9, 15 and 19."}
• {"endpoint_text":"- Functional mobility: measured with the Time Up and Go (TUG). Assessed on week 1, 2, 9, 15 and 19","definition_or_measurement_approach":"Measured using the Time Up and Go (TUG) test; assessed at weeks 1, 2, 9, 15 and 19."}
• {"endpoint_text":"- Muscle ultrasound (morphometric and densitometric variables): measured with ultrasound imaging. Assessed every week from 1 to 15 and on the 19 week (in week 3, two assessments will be conducted - one before the treatment and one after)","definition_or_measurement_approach":"Measured with ultrasound imaging capturing morphometric and densitometric variables; assessed weekly weeks 1–15 and at week 19 (week 3: two assessments, before and after treatment)."}
• {"endpoint_text":"- Quality of life: measured with the EuroQoL-5D. Assessed on week 1, 15 and 19","definition_or_measurement_approach":"Measured with the EuroQoL-5D questionnaire; assessed at weeks 1, 15 and 19."}
• {"endpoint_text":"- Cost-effectiveness: measured with a cost-effectiveness analysis. It will be done after every intervention session (from 3 to 15 week and on 19)","definition_or_measurement_approach":"Measured via a cost-effectiveness analysis performed after every intervention session (weeks 3–15) and at week 19."}
• {"endpoint_text":"- sample size, recruitment, and consent rates will be determined, as well as the safety and feasibility of both treatments","definition_or_measurement_approach":"Descriptive assessment of sample size achievement, recruitment and consent rates, and evaluation of safety and feasibility of both interventions."}

Belgium

Earliest CTIS Part Ii Submission Date

27-06-2024

Latest Decision Or Authorization Date

26-02-2025

Processing Time Days

244

Number Of Sites

1

Number Of Participants

30

Spain

Earliest CTIS Part Ii Submission Date

11-06-2024

Latest Decision Or Authorization Date

02-03-2026

Processing Time Days

629

Number Of Sites

1

Number Of Participants

30

Primary sponsor

Full Name

University Of Antwerp

Organisation Type

Educational Institution

Country Of Registered Address

Belgium