NCT05519592Unknown不适用
Proximal Lower Limb Intramuscular Block : Effects on Hemiparetic Gait
Henri Mondor University Hospital0 个研究点目标入组 30 人开始时间: 2022年9月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Change from baseline of the active amplitude of hip flexion, knee flexion and ankle flexion
研究概览
简要总结
To assess feasability, tolerance of anesthesic intramuscular motor block. To study immediate effects on differents muscles : gluteus maximus, rectus femoris in a hemiparetic population (over 15 days) To precise the role of the muscles which could be rehabilitatoin targets.
详细描述
Spastic paresis comprises both muscular and neurological disorders affecting movement through mostly the antagonist muscles compared to the agonist : muscular : spastic myopathy, shortening, stretch-sensitive paresis and neurogenic : spastic dystonia and cocontraction.
About gait, most of the litterature focuses on distal muscles targets. There are no studies about proxmial muscles role (gluteus maximus). Anesthesic perineural block have the disavantage to induce sensitive block as intramuscular block do not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •able to consent
- •avoiding ground swing phase gait disorder
排除标准
- •severe cognitive disorder
- •INR > 3.5
- •local cutaneous affection on injection sites
- •acute medical affection
- •hypersensitivity to anesthesics
- •brugada syndrome
- •porphyria
- •severe cardiac disorder
- •polyradiculopathy
- •botulinum toxin injection < 2 months
研究组 & 干预措施
Ropivacaine
Experimental
Ropivacaine intramuscular injection
干预措施: Ropivacaine injection (Drug)
Control
Placebo Comparator
Sodium Chlorure intramuscular injection
干预措施: Sodium Chloride Injection (Drug)
结局指标
主要结局
Change from baseline of the active amplitude of hip flexion, knee flexion and ankle flexion
时间窗: baseline, day 7 and day 14
次要结局
- change from baseline of Passive range of motion of gastrocnemius (muscle length in degrees)(baseline, day 7 and day 14)
- change from baseline of the walking speed, at comfortable speed with shoes(baseline, day 7 and day 14)
- change from baseline of the right step length, at maximal speed, without shoes(baseline, day 7 and day 14)
- change from baseline of the right step length, at comfortable speed, without shoes(baseline, day 7 and day 14)
- change from baseline of the left step length, at maximal speed, without shoes(baseline, day 7 and day 14)
- change from baseline of the left step length, at comfortable speed, without shoes(baseline, day 7 and day 14)
- change from baseline of Proprioception detection of rectus femoris (minimal detectable change in degrees)(baseline, day 7 and day 14)
- change from baseline of the walking speed, at maximal speed, with shoes(baseline, day 7 and day 14)
- change from baseline of the walking speed, at comfortable speed without shoes(baseline, day 7 and day 14)
- change from baseline of the left step length, at maximal speed, with shoes(baseline, day 7 and day 14)
- change from baseline of the right step length, at comfortable speed, with shoes(baseline, day 7 and day 14)
- change from baseline of Proprioception detection of soleus (minimal detectable change in degrees)(baseline, day 7 and day 14)
- change from baseline of Passive range of motion of vastus (muscle length in degrees)(baseline, day 7 and day 14)
- change from baseline of fatigability against hamstrings (in degrees, after 15 second of alternative movement)(baseline, day 7 and day 14)
- change from baseline of left foot load(baseline, day 7 and day 14)
- change from baseline of swing time(baseline, day 7 and day 14)
- change from baseline of the walking speed, at maximal speed, without shoes(baseline, day 7 and day 14)
- change from baseline of the right step length, at maximal speed, with shoes(baseline, day 7 and day 14)
- change from baseline of the cadence (step per second), at comfortable speed, without shoes(baseline, day 7 and day 14)
- change from baseline of the cadence (step per second), at comfortable speed, with shoes(baseline, day 7 and day 14)
- change from baseline of the cadence (step per second), at maximal speed, with shoes(baseline, day 7 and day 14)
- change from baseline of the cadence (step per second), at maximal speed, without shoes(baseline, day 7 and day 14)
- change from baseline of Proprioception detection of gastrocnemius (minimal detectable change in degrees)(baseline, day 7 and day 14)
- change from baseline of Passive range of motion of gluteus maximus (muscle length in degrees)(baseline, day 7 and day 14)
- change from baseline of Passive range of motion of rectus femoris (muscle length in degrees)(baseline, day 7 and day 14)
- change from baseline of Passive range of motion of soleus (muscle length in degrees)(baseline, day 7 and day 14)
- change from baseline of Passive range of motion of hamstrings (muscle length in degrees)(baseline, day 7 and day 14)
- change from baseline of the left step length, at comfortable speed, with shoes(baseline, day 7 and day 14)
- change from baseline of Proprioception detection of gluteus maximus (minimal detectable change in degrees)(baseline, day 7 and day 14)
- change from baseline of Proprioception detection of hamstrings (minimal detectable change in degrees)(baseline, day 7 and day 14)
- change from baseline of Proprioception detection of vastus (minimal detectable change in degrees)(baseline, day 7 and day 14)
- change from baseline of spasticity (angle in degrees) of gluteus maximus(baseline, day 7 and day 14)
- change from baseline of active amplitude against soleus(baseline, day 7 and day 14)
- change from baseline of active amplitude against gluteus maximus(baseline, day 7 and day 14)
- change from baseline of active amplitude against vastus(baseline, day 7 and day 14)
- change from baseline of right foot pressure distribution(baseline, day 7 and day 14)
- change from baseline of spasticity (angle in degrees) of hamstrings(baseline, day 7 and day 14)
- change from baseline of active amplitude against gastrocnemius(baseline, day 7 and day 14)
- change from baseline of active amplitude against hamstrings(baseline, day 7 and day 14)
- change from baseline of left foot pressure distribution(baseline, day 7 and day 14)
- change from baseline of right foot load(baseline, day 7 and day 14)
- change from baseline of stride velocity variability(baseline, day 7 and day 14)
- change from baseline of stride time assymetry(baseline, day 7 and day 14)
- change from baseline of stance time(baseline, day 7 and day 14)
- change from baseline of stride velocity(baseline, day 7 and day 14)
- change from baseline of spasticity (angle in degrees) of vastus(baseline, day 7 and day 14)
- change from baseline of spasticity (angle in degrees) of gastrocnemius(baseline, day 7 and day 14)
- change from baseline of active amplitude against rectus femoris(baseline, day 7 and day 14)
- change from baseline of fatigability against gastrocnemius (in degrees, after 15 second of alternative movement)(baseline, day 7 and day 14)
- change from baseline of swing time assymetry(baseline, day 7 and day 14)
- change from baseline of spasticity (angle in degrees) of rectus femoris(baseline, day 7 and day 14)
- change from baseline of spasticity (angle in degrees) of soleus(baseline, day 7 and day 14)
- change from baseline of fatigability against vastus (in degrees, after 15 second of alternative movement)(baseline, day 7 and day 14)
- change from baseline of fatigability against soleus (in degrees, after 15 second of alternative movement)(baseline, day 7 and day 14)
- change from baseline of patient global impression of improvement(baseline, day 7 and day 14)
- change from baseline of fatigability against rectus femoris (in degrees, after 15 second of alternative movement)(baseline, day 7 and day 14)
- change from baseline of fatigability against gluteus maximus (in degrees, after 15 second of alternative movement)(baseline, day 7 and day 14)
- change from baseline of stride length variability(baseline, day 7 and day 14)
- change from baseline of stride time variability(baseline, day 7 and day 14)
- change from baseline of stance time variability(baseline, day 7 and day 14)
- change from baseline of double support time variability(baseline, day 7 and day 14)
- change from baseline of stride time(baseline, day 7 and day 14)
研究者
ETIENNE SAVARD
Hospital Practictioner
Henri Mondor University Hospital
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