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

NCT03307135 | Completed DMC

• 1 other identifier: RC17_0028
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

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.

Conditions

Spasticity, Muscle

Keywords

Spasticity; electrophysiology; biomechanics; objective assessment

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (54)

• duration of the mobilization (sec)

  Day0

• duration of the mobilization (sec),

  Day7

• duration of the mobilization (sec),

  30minutes to 2 hours after an anesthesic block

• duration of the mobilization (sec),

  2 to 3 months after neurotomy or botulinium toxin injection

• range of motion (degree),

  Day0

Study Arms (3)

Simple Assessment group

EXPERIMENTAL

Intervention is a single evaluation with the MSPMI by two evaluators.

Device: single assessment with the MSPMI

Hospitalization group

EXPERIMENTAL

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

Treatment group

EXPERIMENTAL

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

Interventions

single assessment with the MSPMI DEVICE

Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)

Simple Assessment group

double assessment with the MSPMI with 7 days of interval DEVICE

Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)

Hospitalization group

double assessment with the MSPMI before and after treatment DEVICE

Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)

Treatment group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nantes University Hospital: lead
• Compiègne University of Technology: collaborator

Study Sites (1)

Médecine Physique et Réadaptation Neurologique

Nantes, 44000, France

Location

Related Publications (6)

• Bar-On L, Aertbelien 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.

  PMID: 23791154 BACKGROUND

• Bar-On L, Van Campenhout A, Desloovere K, Aertbelien 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.

  PMID: 23994052 BACKGROUND

• 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.

  PMID: 20663189 BACKGROUND

• Schless SH, Desloovere K, Aertbelien 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.

  PMID: 26134673 BACKGROUND

• Gaverth 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.

  PMID: 23695917 BACKGROUND

• 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.

  PMID: 18776066 BACKGROUND

MeSH Terms

Conditions

Muscle Spasticity

Interventions

Physical Examination; Aftercare

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Brigitte Perrouin-Verbe, PU-PH

  Nantes CHU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2017
• First Posted: October 11, 2017
• Study Start: October 10, 2017
• Primary Completion: September 10, 2019
• Study Completion: March 13, 2020
• Last Updated: November 30, 2020

Record last verified: 2020-11

Locations

FR (1)