Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity

Nantes University Hospital1 个研究点分布在 1 个国家目标入组 67 人开始时间: 2017年10月10日最近更新: 2020年11月30日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Nantes University Hospital
入组人数: 67
试验地点: 1
主要终点: Maximal value of EMG for Soleus (μv) reproductibility coefficient

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Spasticity is a disorder of the muscular tonus that occurs in disease including the upper motor neuron (strokes, spinal cord injuries, multiple sclerosis, traumatic brain injuries or cerebral palsies). It begins few hours after the neural aggression and last until the grave.

The most accepted definition refers to a velocity-dependent increase in stretch reflexes elicited by passive stretch (Lance definition) but new approaches prefers to distinguish neural (reflex) and non-neural (soft tissues alterations) components of the increase resistance to a passive stretch. This deficiency is a major cause of complications as walking impairment, pain or bone deformities and may require intensive therapies (intrathecal baclofen infusion, intramuscular toxin botulinium injection, surgery, etc). Despite its high frequency and the potential complications, only clinical scales (modified Ashworth scale and modified Tardieu scale essentially) with criticized metrological properties are available for daily assessment. The SPASM Consortium has published on 2005 recommendations for developing devices using both mechanical and electrophysiological parameters. The principle challenge was to ally parameters accuracy and utilization facility allowing quickly evaluation to the patient's bed. Few research team works on this topic but mostly on specific population and nowadays, no device has really crossed the door of laboratories.

This kind of tool would help us to improve the quality of the follow-up and to guide us between the choices of specific therapies.

The MSPMI has been created following these recommendations in the University of Technology of Compiègne, thanks to the collaboration between researchers of the UMR 7338 CNRS and a brain surgeon of the Nantes University Hospital. The patent was obtained on 2012. This device allows the assessment of the ankle plantar extensor (triceps surae) during a manually applied stretch movement. This muscle was selected as it is frequently involved and treated for spasticity.

This study aims to evaluate the metrological properties of the MSPMI (reliabilities, responsiveness, known group validity, construct validity, measurement errors and internal consistency) among a large cohort of patients with no restriction of etiologies recruited in the Nantes University Hospital.

详细描述

Evaluation will include medical histories and specific information about spasticity management and consequences. The patient will be assessed by two evaluators with the MSPMI installed on the foot and the shank. MSPMI allows the record of angular movement of the ankle (position, speed and acceleration), of biomechanics (stiffness, torque, work and power) and electromyography (root mean squared and integrated electromyography signals) of two chiefs of the triceps surae (medial gastrocnemius and soleus). Electromyography data will be recorded on a maximum voluntary contraction when the deficiency will permit it. After that, data will be recorded at 3 velocities (with respect to the clinical scale recommendations) on two different positions (knee flexed and extended), according to our clinical practice. The evaluation on day 0 will allow the assessment of inter-rater intra-session reproductibility, internal consistency, construct validity, measurement error and known group validity. If the patient is hospitalized, he will be included on the "hospitalization group" and a second evaluation following the same protocol will be done 7 days later (assessment of inter and intra-rater inter-session reproductibility). If a specific therapy (selective tibial neurotomy, anesthetic block or botulinum toxin intramuscular injection) is proposed, the patient will be included on the "treatment group" and a new evaluation will be done after the therapy (30 minutes - 2 hours after an anesthetic block, 2-3 months after neurotomy or botulinium toxin injection) allowing assessment of the responsiveness of the MSPMI. If the patient is not on these two situations, he will be included on the "simple evaluation group" and his participation will end.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Other
盲法: None

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Spasticity with respect to the Lance defintion (minimal score of 1 on the modified Ashworth scale)

排除标准

•Contraindication of ankle manipulation : fracture, phlebitis, bedsore
•amyotrophic lateral sclerosis

研究组 & 干预措施

Simple Assessment group

Experimental

Intervention is a single evaluation with the MSPMI by two evaluators.

干预措施: single assessment with the MSPMI (Device)

Hospitalization group

Experimental

Evaluation with the MSPMI by two evaluators on two consultations separate by a 7 days interval.

干预措施: double assessment with the MSPMI with 7 days of interval (Device)

Treatment group

Experimental

Evaluation with the MSPMI by two evaluators before and after specific therapies proposed on our usual practices (Selective tibial neurotomy, anesthetic block or botulinum toxin intramuscular injection).

干预措施: double assessment with the MSPMI before and after treatment (Device)