An interventional study of single assessment with the MSPMI and double assessment with the MSPMI with 7 days of interval in Spasticity, Muscle, sponsored by Nantes University Hospital. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2020-11-30.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Other
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.
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.
Exclusion Criteria:
Intervention is a single evaluation with the MSPMI by two evaluators.
Device: single assessment with the MSPMI
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
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
Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
Duration of the mobilization reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Time frame: Day 0
range of motion (degree) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Time frame: Day 0
maximal angular speed (degree.sec-1) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Time frame: Day 0
torque peaque (N.m) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Time frame: Day 0
work variability index (mJ.sec) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Time frame: Day 0
area under the curve raw Work = f(time) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Time frame: Day 0
area under the curve rectified Work = f(time) (J.sec) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Time frame: 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
Time frame: Day 0
Raw rectified EMG for Soleus (μv) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Time frame: Day 0
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Time frame: Day 0
Averaged rectified EMG for Soleus (μv.sec-1) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Time frame: Day 0
Maximal value of EMG for Gastrocnemius medialis (μv) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Time frame: Day 0
Maximal value of EMG for Soleus (μv) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Time frame: Day 0
duration of the mobilization (sec)
Patients of the 3 groups
Time frame: Day0
duration of the mobilization (sec),
Patients included in the "hospitalization group"
Time frame: Day7
duration of the mobilization (sec),
Patients included in the "treatment group" and treated by anesthesic block
Time frame: 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
Time frame: 2 to 3 months after neurotomy or botulinium toxin injection
range of motion (degree),
Patients of the 3 groups
Time frame: Day0
range of motion (degree),
Patients included in the "hospitalization group"
Time frame: Day7
range of motion (degree),
Patients included in the "treatment group" and treated by anesthesic block
Time frame: 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
Time frame: 2 to 3 months after neurotomy or botulinium toxin injection
maximal angular speed (degree.sec-1)
Patients of the 3 groups
Time frame: Day 0
maximal angular speed (degree.sec-1)
Patients included in the "hospitalization group"
Time frame: Day 7
maximal angular speed (degree.sec-1)
Patients included in the "treatment group" and treated by anesthesic block
Time frame: 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
Time frame: 2 to 3 months after neurotomy or botulinium toxin injection
torque peaque (N.m)
Patients of the 3 groups
Time frame: Day 0
torque peaque (N.m)
Patients included in the "hospitalization group"
Time frame: Day 7
torque peaque (N.m)
Patients included in the "treatment group" and treated by anesthesic block
Time frame: 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
Time frame: 2 to 3 months after neurotomy or botulinium toxin injection
work variability index (mJ.sec)
Patients of the 3 groups
Time frame: Day0
work variability index (mJ.sec)
Patients included in the "hospitalization group"
Time frame: Day7
work variability index (mJ.sec)
Patients included in the "treatment group" and treated by anesthesic block
Time frame: 30minutes to 2 hours after an anesthesic block
work variability index (mJ.sec)
Time frame: 2 to 3 months after neurotomy or botulinium toxin injection
area under the curve raw Work = f(time)
Patients of the 3 groups
Time frame: Day 0
area under the curve raw Work = f(time)
Patients included in the "hospitalization group"
Time frame: Day 7
area under the curve raw Work = f(time)
Patients included in the "treatment group" and treated by anesthesic block
Time frame: 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
Time frame: 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
Time frame: Day 0
area under the curve rectified Work = f(time) (J.sec)
Patients included in the "hospitalization group"
Time frame: Day 7
area under the curve rectified Work = f(time) (J.sec)
Patients included in the "treatment group" and treated by anesthesic block
Time frame: 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
Time frame: 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
Time frame: Day 0
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Patients included in the "hospitalization group"
Time frame: Day 7
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Patients included in the "treatment group" and treated by anesthesic block
Time frame: 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
Time frame: 2 to 3 months after neurotomy or botulinium toxin injection
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Patients of the 3 groups
Time frame: Day0
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Patients included in the "hospitalization group"
Time frame: Day7
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Patients included in the "treatment group" and treated by anesthesic block
Time frame: 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
Time frame: 2 to 3 months after neurotomy or botulinium toxin injection
Raw rectified EMG for Soleus (μv)
Patients of the 3 groups
Time frame: Day 0
Raw rectified EMG for Soleus (μv)
Patients included in the "hospitalization group"
Time frame: Day 7
Raw rectified EMG for Soleus (μv)
Patients included in the "treatment group" and treated by anesthesic block
Time frame: 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
Time frame: 2 to 3 months after neurotomy or botulinium toxin injection
Averaged rectified EMG for Soleus (μv.sec-1)
Patients of the 3 groups
Time frame: Day 0
Averaged rectified EMG for Soleus (μv.sec-1)
Patients included in the "hospitalization group"
Time frame: Day 7
Averaged rectified EMG for Soleus (μv.sec-1)
Patients included in the "treatment group" and treated by anesthesic block
Time frame: 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
Time frame: 2 to 3 months after neurotomy or botulinium toxin injection
maximal value of EMG for Gastrocnemius medialis (μV)
Patients of the 3 groups
Time frame: Day0
maximal value of EMG for Gastrocnemius medialis (μV)
Patients included in the "hospitalization group"
Time frame: Day7
maximal value of EMG for Gastrocnemius medialis (μV)
Patients included in the "treatment group" and treated by anesthesic block
Time frame: 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
Time frame: 2 to 3 months after neurotomy or botulinium toxin injection
Maximal value of EMG for Soleus (μv)
Patients of the 3 groups
Time frame: Day 0
Maximal value of EMG for Soleus (μv)
Patients included in the "hospitalization group"
Time frame: Day 7
Maximal value of EMG for Soleus (μv)
Patients included in the "treatment group" and treated by anesthesic block
Time frame: 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
Time frame: 2 to 3 months after neurotomy or botulinium toxin injection
score on the modified Asworth scale
Patients of the 3 groups
Time frame: Day 0
modified Tardieu scale assigned by the evaluator
Patients of the 3 groups
Time frame: Day 0
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