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

Not Applicable

Completed

• Conditions: Spasticity, Muscle
• Interventions: Device: single assessment with the MSPMI; Device: double assessment with the MSPMI before and after treatment; Device: double assessment with the MSPMI with 7 days of interval

• Registration Number: NCT03307135
• Lead Sponsor: Nantes University Hospital

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-10-05
• Study Start: 2017-10-10
• Study First Posted: 2017-10-11
• Primary Completion: 2019-09-10
• Study Completion: 2020-03-13
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-26
• Last Update Posted: 2020-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Simple Assessment group	single assessment with the MSPMI	Intervention is a single evaluation with the MSPMI by two evaluators.
Treatment group	double assessment with the MSPMI before and after treatment	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).
Hospitalization group	double assessment with the MSPMI with 7 days of interval	Evaluation with the MSPMI by two evaluators on two consultations separate by a 7 days interval.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Médecine Physique et Réadaptation Neurologique; 🇫🇷 Nantes, France