Clinical trial NCT03307135: Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity
Official title: Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spasticity, Muscle
Keywords: Spasticity
electrophysiology
biomechanics
objective assessment
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Compiègne University of Technology
First posted: 2017-10-11
Enrollment: 67
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of the mobilization reproductibility coefficient
timeFrame: Day 0
measure: range of motion (degree) reproductibility coefficient
timeFrame: Day 0
measure: maximal angular speed (degree.sec-1) reproductibility coefficient
timeFrame: Day 0
measure: torque peaque (N.m) reproductibility coefficient
timeFrame: Day 0
measure: work variability index (mJ.sec) reproductibility coefficient
timeFrame: Day 0
measure: area under the curve raw Work = f(time) reproductibility coefficient
timeFrame: Day 0
measure: area under the curve rectified Work = f(time) (J.sec) reproductibility coefficient
timeFrame: Day 0
measure: raw and averaged rectified EMG for Soleus and Gastrocnemius medialis (μV and μV.sec-1) reproductibility coefficient
timeFrame: Day 0
measure: Raw rectified EMG for Soleus (μv) reproductibility coefficient
timeFrame: Day 0
measure: Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) reproductibility coefficient
timeFrame: Day 0
measure: Averaged rectified EMG for Soleus (μv.sec-1) reproductibility coefficient
timeFrame: Day 0
measure: Maximal value of EMG for Gastrocnemius medialis (μv) reproductibility coefficient
timeFrame: Day 0
measure: Maximal value of EMG for Soleus (μv) reproductibility coefficient
timeFrame: Day 0
Secondary outcomes:
measure: duration of the mobilization (sec)
timeFrame: Day0
measure: duration of the mobilization (sec),
timeFrame: Day7
measure: duration of the mobilization (sec),
timeFrame: 30minutes to 2 hours after an anesthesic block
measure: duration of the mobilization (sec),
timeFrame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: range of motion (degree),
timeFrame: Day0
measure: range of motion (degree),
timeFrame: Day7
measure: range of motion (degree),
timeFrame: 30minutes to 2 hours after an anesthesic block
measure: range of motion (degree),
timeFrame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: maximal angular speed (degree.sec-1)
timeFrame: Day 0
measure: maximal angular speed (degree.sec-1)
timeFrame: Day 7
measure: maximal angular speed (degree.sec-1)
timeFrame: 30minutes to 2 hours after an anesthesic block
measure: maximal angular speed (degree.sec-1)
timeFrame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: torque peaque (N.m)
timeFrame: Day 0
measure: torque peaque (N.m)
timeFrame: Day 7
measure: torque peaque (N.m)
timeFrame: 30minutes to 2 hours after an anesthesic block
measure: torque peaque (N.m)
timeFrame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: work variability index (mJ.sec)
timeFrame: Day0
measure: work variability index (mJ.sec)
timeFrame: Day7
measure: work variability index (mJ.sec)
timeFrame: 30minutes to 2 hours after an anesthesic block
measure: work variability index (mJ.sec)
timeFrame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: area under the curve raw Work = f(time)
timeFrame: Day 0
measure: area under the curve raw Work = f(time)
timeFrame: Day 7
measure: area under the curve raw Work = f(time)
timeFrame: 30minutes to 2 hours after an anesthesic block
measure: area under the curve raw Work = f(time)
timeFrame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: area under the curve rectified Work = f(time) (J.sec)
timeFrame: Day 0
measure: area under the curve rectified Work = f(time) (J.sec)
timeFrame: Day 7
measure: area under the curve rectified Work = f(time) (J.sec)
timeFrame: 30minutes to 2 hours after an anesthesic block
measure: area under the curve rectified Work = f(time) (J.sec)
timeFrame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
timeFrame: Day 0
measure: raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
timeFrame: Day 7
measure: raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
timeFrame: 30minutes to 2 hours after an anesthesic block
measure: raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
timeFrame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
timeFrame: Day0
measure: Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
timeFrame: Day7
measure: Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
timeFrame: 30minutes to 2 hours after an anesthesic block
measure: Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
timeFrame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: Raw rectified EMG for Soleus (μv)
timeFrame: Day 0
measure: Raw rectified EMG for Soleus (μv)
timeFrame: Day 7
measure: Raw rectified EMG for Soleus (μv)
timeFrame: 30minutes to 2 hours after an anesthesic block
measure: Raw rectified EMG for Soleus (μv)
timeFrame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: Averaged rectified EMG for Soleus (μv.sec-1)
timeFrame: Day 0
measure: Averaged rectified EMG for Soleus (μv.sec-1)
timeFrame: Day 7
measure: Averaged rectified EMG for Soleus (μv.sec-1)
timeFrame: 30minutes to 2 hours after an anesthesic block
measure: Averaged rectified EMG for Soleus (μv.sec-1)
timeFrame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: maximal value of EMG for Gastrocnemius medialis (μV)
timeFrame: Day0
measure: maximal value of EMG for Gastrocnemius medialis (μV)
timeFrame: Day7
measure: maximal value of EMG for Gastrocnemius medialis (μV)
timeFrame: 30minutes to 2 hours after an anesthesic block
measure: maximal value of EMG for Gastrocnemius medialis (μV)
timeFrame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: Maximal value of EMG for Soleus (μv)
timeFrame: Day 0
measure: Maximal value of EMG for Soleus (μv)
timeFrame: Day 7
measure: Maximal value of EMG for Soleus (μv)
timeFrame: 30minutes to 2 hours after an anesthesic block
measure: Maximal value of EMG for Soleus (μv)
timeFrame: 2 to 3 months after neurotomy or botulinium toxin injection
measure: score on the modified Asworth scale
timeFrame: Day 0
measure: modified Tardieu scale assigned by the evaluator
timeFrame: Day 0
Other outcomes:
Locations:
city: Nantes
country: France
facility: Médecine Physique et Réadaptation Neurologique
Study officials:
affiliation: Nantes CHU
name: Brigitte Perrouin-Verbe, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
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