2024-510866-18-00
招募中
2 期
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
概览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- 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
概览
简要总结
To understand the effects that BTX A and Dry Needling have on post-stroke spasticity in the lower limbs at the spinal level
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
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
次要结局
- 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).
- 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
- Functional mobility: measured with the Time Up and Go (TUG). Assessed on week 1, 2, 9, 15 and 19
- 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)
- Quality of life: measured with the EuroQoL-5D. Assessed on week 1, 15 and 19
- Cost-effectiveness: measured with a cost-effectiveness analysis. It will be done after every intervention session (from 3 to 15 week and on 19)
- sample size, recruitment, and consent rates will be determined, as well as the safety and feasibility of both treatments
研究者
研究点 (2)
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