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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Spasticity, Muscle

Intervention / Treatment
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* Device: single assessment with the MSPMI
* Device: double assessment with the MSPMI with 7 days of interval
* Device: double assessment with the MSPMI before and after treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Spasticity with respect to the Lance defintion (minimal score of 1 on the modified Ashworth scale) Exclusion Criteria: Contraindication of ankle manipulation : fracture, phlebitis, bedsore amyotrophic lateral sclerosis
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simple Assessment group<br>Intervention is a single evaluation with the MSPMI by two evaluators. | Device: single assessment with the MSPMI<br>* Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)<br>|
| Experimental: Hospitalization group<br>Evaluation with the MSPMI by two evaluators on two consultations separate by a 7 days interval. | Device: double assessment with the MSPMI with 7 days of interval<br>* Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)<br>|
| Experimental: Treatment group<br>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). | Device: double assessment with the MSPMI before and after treatment<br>* Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the mobilization reproductibility coefficient | inter-rater intra-session reproductibility coefficient | Day 0 | 
| range of motion (degree) reproductibility coefficient | inter-rater intra-session reproductibility coefficient | Day 0 | 
| maximal angular speed (degree.sec-1) reproductibility coefficient | inter-rater intra-session reproductibility coefficient | Day 0 | 
| torque peaque (N.m) reproductibility coefficient | inter-rater intra-session reproductibility coefficient | Day 0 | 
| work variability index (mJ.sec) reproductibility coefficient | inter-rater intra-session reproductibility coefficient | Day 0 | 
| area under the curve raw Work = f(time) reproductibility coefficient | inter-rater intra-session reproductibility coefficient | Day 0 | 
| area under the curve rectified Work = f(time) (J.sec) reproductibility coefficient | inter-rater intra-session reproductibility coefficient | Day 0 | 
| raw and averaged rectified EMG for Soleus and Gastrocnemius medialis (μV and μV.sec-1) reproductibility coefficient | inter-rater intra-session reproductibility coefficient | Day 0 | 
| Raw rectified EMG for Soleus (μv) reproductibility coefficient | inter-rater intra-session reproductibility coefficient | Day 0 | 
| Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) reproductibility coefficient | inter-rater intra-session reproductibility coefficient | Day 0 | 
| Averaged rectified EMG for Soleus (μv.sec-1) reproductibility coefficient | inter-rater intra-session reproductibility coefficient | Day 0 | 
| Maximal value of EMG for Gastrocnemius medialis (μv) reproductibility coefficient | inter-rater intra-session reproductibility coefficient | Day 0 | 
| Maximal value of EMG for Soleus (μv) reproductibility coefficient | inter-rater intra-session reproductibility coefficient | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of the mobilization (sec) | Patients of the 3 groups | Day0 | 
| duration of the mobilization (sec), | Patients included in the hospitalization group | Day7 | 
| duration of the mobilization (sec), | Patients included in the treatment group and treated by anesthesic block | 30minutes to 2 hours after an anesthesic block | 
| duration of the mobilization (sec), | Patients included in the treatment group and treated by selective tibial neurotomy or toxin intramuscular injection | 2 to 3 months after neurotomy or botulinium toxin injection | 
| range of motion (degree), | Patients of the 3 groups | Day0 | 
| range of motion (degree), | Patients included in the hospitalization group | Day7 | 
| range of motion (degree), | Patients included in the treatment group and treated by anesthesic block | 30minutes to 2 hours after an anesthesic block | 
| range of motion (degree), | Patients included in the treatment group and treated by selective tibial neurotomy or toxin intramuscular injection | 2 to 3 months after neurotomy or botulinium toxin injection | 
| maximal angular speed (degree.sec-1) | Patients of the 3 groups | Day 0 | 
| maximal angular speed (degree.sec-1) | Patients included in the hospitalization group | Day 7 | 
| maximal angular speed (degree.sec-1) | Patients included in the treatment group and treated by anesthesic block | 30minutes to 2 hours after an anesthesic block | 
| maximal angular speed (degree.sec-1) | Patients included in the treatment group and treated by selective tibial neurotomy or toxin intramuscular injection | 2 to 3 months after neurotomy or botulinium toxin injection | 
| torque peaque (N.m) | Patients of the 3 groups | Day 0 | 
| torque peaque (N.m) | Patients included in the hospitalization group | Day 7 | 
| torque peaque (N.m) | Patients included in the treatment group and treated by anesthesic block | 30minutes to 2 hours after an anesthesic block | 
| torque peaque (N.m) | Patients included in the treatment group and treated by selective tibial neurotomy or toxin intramuscular injection | 2 to 3 months after neurotomy or botulinium toxin injection | 
| work variability index (mJ.sec) | Patients of the 3 groups | Day0 | 
| work variability index (mJ.sec) | Patients included in the hospitalization group | Day7 | 
| work variability index (mJ.sec) | Patients included in the treatment group and treated by anesthesic block | 30minutes to 2 hours after an anesthesic block | 
| work variability index (mJ.sec) |  | 2 to 3 months after neurotomy or botulinium toxin injection | 
| area under the curve raw Work = f(time) | Patients of the 3 groups | Day 0 | 
| area under the curve raw Work = f(time) | Patients included in the hospitalization group | Day 7 | 
| area under the curve raw Work = f(time) | Patients included in the treatment group and treated by anesthesic block | 30minutes to 2 hours after an anesthesic block | 
| area under the curve raw Work = f(time) | Patients included in the treatment group and treated by selective tibial neurotomy or toxin intramuscular injection | 2 to 3 months after neurotomy or botulinium toxin injection | 
| area under the curve rectified Work = f(time) (J.sec) | Patients of the 3 groups | Day 0 | 
| area under the curve rectified Work = f(time) (J.sec) | Patients included in the hospitalization group | Day 7 | 
| area under the curve rectified Work = f(time) (J.sec) | Patients included in the treatment group and treated by anesthesic block | 30minutes to 2 hours after an anesthesic block | 
| area under the curve rectified Work = f(time) (J.sec) | Patients included in the treatment group and treated by selective tibial neurotomy or toxin intramuscular injection | 2 to 3 months after neurotomy or botulinium toxin injection | 
| raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1) | Patients of the 3 groups | Day 0 | 
| raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1) | Patients included in the hospitalization group | Day 7 | 
| raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1) | Patients included in the treatment group and treated by anesthesic block | 30minutes to 2 hours after an anesthesic block | 
| raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1) | Patients included in the treatment group and treated by selective tibial neurotomy or toxin intramuscular injection | 2 to 3 months after neurotomy or botulinium toxin injection | 
| Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) | Patients of the 3 groups | Day0 | 
| Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) | Patients included in the hospitalization group | Day7 | 
| Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) | Patients included in the treatment group and treated by anesthesic block | 30minutes to 2 hours after an anesthesic block | 
| Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) | Patients included in the treatment group and treated by selective tibial neurotomy or toxin intramuscular injection | 2 to 3 months after neurotomy or botulinium toxin injection | 
| Raw rectified EMG for Soleus (μv) | Patients of the 3 groups | Day 0 | 
| Raw rectified EMG for Soleus (μv) | Patients included in the hospitalization group | Day 7 | 
| Raw rectified EMG for Soleus (μv) | Patients included in the treatment group and treated by anesthesic block | 30minutes to 2 hours after an anesthesic block | 
| Raw rectified EMG for Soleus (μv) | Patients included in the treatment group and treated by selective tibial neurotomy or toxin intramuscular injection | 2 to 3 months after neurotomy or botulinium toxin injection | 
| Averaged rectified EMG for Soleus (μv.sec-1) | Patients of the 3 groups | Day 0 | 
| Averaged rectified EMG for Soleus (μv.sec-1) | Patients included in the hospitalization group | Day 7 | 
| Averaged rectified EMG for Soleus (μv.sec-1) | Patients included in the treatment group and treated by anesthesic block | 30minutes to 2 hours after an anesthesic block | 
| Averaged rectified EMG for Soleus (μv.sec-1) | Patients included in the treatment group and treated by selective tibial neurotomy or toxin intramuscular injection | 2 to 3 months after neurotomy or botulinium toxin injection | 
| maximal value of EMG for Gastrocnemius medialis (μV) | Patients of the 3 groups | Day0 | 
| maximal value of EMG for Gastrocnemius medialis (μV) | Patients included in the hospitalization group | Day7 | 
| maximal value of EMG for Gastrocnemius medialis (μV) | Patients included in the treatment group and treated by anesthesic block | 30minutes to 2 hours after an anesthesic block | 
| maximal value of EMG for Gastrocnemius medialis (μV) | Patients included in the treatment group and treated by selective tibial neurotomy or toxin intramuscular injection | 2 to 3 months after neurotomy or botulinium toxin injection | 
| Maximal value of EMG for Soleus (μv) | Patients of the 3 groups | Day 0 | 
| Maximal value of EMG for Soleus (μv) | Patients included in the hospitalization group | Day 7 | 
| Maximal value of EMG for Soleus (μv) | Patients included in the treatment group and treated by anesthesic block | 30minutes to 2 hours after an anesthesic block | 
| Maximal value of EMG for Soleus (μv) | Patients included in the treatment group and treated by selective tibial neurotomy or toxin intramuscular injection | 2 to 3 months after neurotomy or botulinium toxin injection | 
| score on the modified Asworth scale | Patients of the 3 groups | Day 0 | 
| modified Tardieu scale assigned by the evaluator | Patients of the 3 groups | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spasticity, electrophysiology, biomechanics, objective assessment