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

Spasticity, Muscle Clinical Trial

— MSPMI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307135
• Other study ID #: RC17_0028
• Status: Completed
• Phase: N/A
• Start date: October 10, 2017
• Est. completion date: March 13, 2020

Study information

• Verified date: November 2020
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 13, 2020
• Est. primary completion date: September 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Muscle Spasticity
• Spasticity, Muscle

Intervention

Device:
• single assessment with the MSPMI
Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
• double assessment with the MSPMI with 7 days of interval
Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
• 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)

Locations

Country	Name	City	State
France	Médecine Physique et Réadaptation Neurologique	Nantes

Sponsors (2)

Lead Sponsor	Collaborator
Nantes University Hospital	Compiègne University of Technology

Country where clinical trial is conducted

France, 

References & Publications (6)

Bar-On L, Aertbeliën E, Molenaers G, Van Campenhout A, Vandendoorent B, Nieuwenhuys A, Jaspers E, Hunaerts C, Desloovere K. Instrumented assessment of the effect of Botulinum Toxin-A in the medial hamstrings in children with cerebral palsy. Gait Posture. 2014 Jan;39(1):17-22. doi: 10.1016/j.gaitpost.2013.05.018. Epub 2013 Jun 20. — View Citation

Bar-On L, Van Campenhout A, Desloovere K, Aertbeliën E, Huenaerts C, Vandendoorent B, Nieuwenhuys A, Molenaers G. Is an instrumented spasticity assessment an improvement over clinical spasticity scales in assessing and predicting the response to integrated botulinum toxin type a treatment in children with cerebral palsy? Arch Phys Med Rehabil. 2014 Mar;95(3):515-23. doi: 10.1016/j.apmr.2013.08.010. Epub 2013 Aug 27. — View Citation

de Vlugt E, de Groot JH, Schenkeveld KE, Arendzen JH, van der Helm FC, Meskers CG. The relation between neuromechanical parameters and Ashworth score in stroke patients. J Neuroeng Rehabil. 2010 Jul 27;7:35. doi: 10.1186/1743-0003-7-35. — View Citation

Gäverth J, Sandgren M, Lindberg PG, Forssberg H, Eliasson AC. Test-retest and inter-rater reliability of a method to measure wrist and finger spasticity. J Rehabil Med. 2013 Jul;45(7):630-6. doi: 10.2340/16501977-1160. — View Citation

Schless SH, Desloovere K, Aertbeliën E, Molenaers G, Huenaerts C, Bar-On L. The Intra- and Inter-Rater Reliability of an Instrumented Spasticity Assessment in Children with Cerebral Palsy. PLoS One. 2015 Jul 2;10(7):e0131011. doi: 10.1371/journal.pone.0131011. eCollection 2015. — View Citation

Turk R, Notley SV, Pickering RM, Simpson DM, Wright PA, Burridge JH. Reliability and sensitivity of a wrist rig to measure motor control and spasticity in poststroke hemiplegia. Neurorehabil Neural Repair. 2008 Nov-Dec;22(6):684-96. doi: 10.1177/1545968308315599. Epub 2008 Sep 5. — View Citation

Outcome

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

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