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NCT Number: NCT03307135

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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Médecine Physique et Réadaptation Neurologique

Nantes, 44000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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)

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)

Primary outcomes

  1. Duration of the mobilization reproductibility coefficient

    Time frame: Day 0

    inter-rater intra-session reproductibility coefficient

  2. range of motion (degree) reproductibility coefficient

    Time frame: Day 0

    inter-rater intra-session reproductibility coefficient

  3. maximal angular speed (degree.sec-1) reproductibility coefficient

    Time frame: Day 0

    inter-rater intra-session reproductibility coefficient

  4. torque peaque (N.m) reproductibility coefficient

    Time frame: Day 0

    inter-rater intra-session reproductibility coefficient

  5. work variability index (mJ.sec) reproductibility coefficient

    Time frame: Day 0

    inter-rater intra-session reproductibility coefficient

  6. area under the curve raw Work = f(time) reproductibility coefficient

    Time frame: Day 0

    inter-rater intra-session reproductibility coefficient

  7. area under the curve rectified Work = f(time) (J.sec) reproductibility coefficient

    Time frame: Day 0

    inter-rater intra-session reproductibility coefficient

  8. raw and averaged rectified EMG for Soleus and Gastrocnemius medialis (μV and μV.sec-1) reproductibility coefficient

    Time frame: Day 0

    inter-rater intra-session reproductibility coefficient

  9. Raw rectified EMG for Soleus (μv) reproductibility coefficient

    Time frame: Day 0

    inter-rater intra-session reproductibility coefficient

  10. Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) reproductibility coefficient

    Time frame: Day 0

    inter-rater intra-session reproductibility coefficient

  11. Averaged rectified EMG for Soleus (μv.sec-1) reproductibility coefficient

    Time frame: Day 0

    inter-rater intra-session reproductibility coefficient

  12. Maximal value of EMG for Gastrocnemius medialis (μv) reproductibility coefficient

    Time frame: Day 0

    inter-rater intra-session reproductibility coefficient

  13. Maximal value of EMG for Soleus (μv) reproductibility coefficient

    Time frame: Day 0

    inter-rater intra-session reproductibility coefficient

Secondary outcomes

  1. duration of the mobilization (sec)

    Time frame: Day0

    Patients of the 3 groups

  2. duration of the mobilization (sec),

    Time frame: Day7

    Patients included in the "hospitalization group"

  3. duration of the mobilization (sec),

    Time frame: 30minutes to 2 hours after an anesthesic block

    Patients included in the "treatment group" and treated by anesthesic block

  4. duration of the mobilization (sec),

    Time frame: 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

  5. range of motion (degree),

    Time frame: Day0

    Patients of the 3 groups

  6. range of motion (degree),

    Time frame: Day7

    Patients included in the "hospitalization group"

  7. range of motion (degree),

    Time frame: 30minutes to 2 hours after an anesthesic block

    Patients included in the "treatment group" and treated by anesthesic block

  8. range of motion (degree),

    Time frame: 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

  9. maximal angular speed (degree.sec-1)

    Time frame: Day 0

    Patients of the 3 groups

  10. maximal angular speed (degree.sec-1)

    Time frame: Day 7

    Patients included in the "hospitalization group"

  11. maximal angular speed (degree.sec-1)

    Time frame: 30minutes to 2 hours after an anesthesic block

    Patients included in the "treatment group" and treated by anesthesic block

  12. maximal angular speed (degree.sec-1)

    Time frame: 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

  13. torque peaque (N.m)

    Time frame: Day 0

    Patients of the 3 groups

  14. torque peaque (N.m)

    Time frame: Day 7

    Patients included in the "hospitalization group"

  15. torque peaque (N.m)

    Time frame: 30minutes to 2 hours after an anesthesic block

    Patients included in the "treatment group" and treated by anesthesic block

  16. torque peaque (N.m)

    Time frame: 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

  17. work variability index (mJ.sec)

    Time frame: Day0

    Patients of the 3 groups

  18. work variability index (mJ.sec)

    Time frame: Day7

    Patients included in the "hospitalization group"

  19. work variability index (mJ.sec)

    Time frame: 30minutes to 2 hours after an anesthesic block

    Patients included in the "treatment group" and treated by anesthesic block

  20. work variability index (mJ.sec)

    Time frame: 2 to 3 months after neurotomy or botulinium toxin injection

  21. area under the curve raw Work = f(time)

    Time frame: Day 0

    Patients of the 3 groups

  22. area under the curve raw Work = f(time)

    Time frame: Day 7

    Patients included in the "hospitalization group"

  23. area under the curve raw Work = f(time)

    Time frame: 30minutes to 2 hours after an anesthesic block

    Patients included in the "treatment group" and treated by anesthesic block

  24. area under the curve raw Work = f(time)

    Time frame: 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

  25. area under the curve rectified Work = f(time) (J.sec)

    Time frame: Day 0

    Patients of the 3 groups

  26. area under the curve rectified Work = f(time) (J.sec)

    Time frame: Day 7

    Patients included in the "hospitalization group"

  27. area under the curve rectified Work = f(time) (J.sec)

    Time frame: 30minutes to 2 hours after an anesthesic block

    Patients included in the "treatment group" and treated by anesthesic block

  28. area under the curve rectified Work = f(time) (J.sec)

    Time frame: 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

  29. raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)

    Time frame: Day 0

    Patients of the 3 groups

  30. raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)

    Time frame: Day 7

    Patients included in the "hospitalization group"

  31. raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)

    Time frame: 30minutes to 2 hours after an anesthesic block

    Patients included in the "treatment group" and treated by anesthesic block

  32. raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)

    Time frame: 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

  33. Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)

    Time frame: Day0

    Patients of the 3 groups

  34. Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)

    Time frame: Day7

    Patients included in the "hospitalization group"

  35. Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)

    Time frame: 30minutes to 2 hours after an anesthesic block

    Patients included in the "treatment group" and treated by anesthesic block

  36. Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)

    Time frame: 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

  37. Raw rectified EMG for Soleus (μv)

    Time frame: Day 0

    Patients of the 3 groups

  38. Raw rectified EMG for Soleus (μv)

    Time frame: Day 7

    Patients included in the "hospitalization group"

  39. Raw rectified EMG for Soleus (μv)

    Time frame: 30minutes to 2 hours after an anesthesic block

    Patients included in the "treatment group" and treated by anesthesic block

  40. Raw rectified EMG for Soleus (μv)

    Time frame: 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

  41. Averaged rectified EMG for Soleus (μv.sec-1)

    Time frame: Day 0

    Patients of the 3 groups

  42. Averaged rectified EMG for Soleus (μv.sec-1)

    Time frame: Day 7

    Patients included in the "hospitalization group"

  43. Averaged rectified EMG for Soleus (μv.sec-1)

    Time frame: 30minutes to 2 hours after an anesthesic block

    Patients included in the "treatment group" and treated by anesthesic block

  44. Averaged rectified EMG for Soleus (μv.sec-1)

    Time frame: 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

  45. maximal value of EMG for Gastrocnemius medialis (μV)

    Time frame: Day0

    Patients of the 3 groups

  46. maximal value of EMG for Gastrocnemius medialis (μV)

    Time frame: Day7

    Patients included in the "hospitalization group"

  47. maximal value of EMG for Gastrocnemius medialis (μV)

    Time frame: 30minutes to 2 hours after an anesthesic block

    Patients included in the "treatment group" and treated by anesthesic block

  48. maximal value of EMG for Gastrocnemius medialis (μV)

    Time frame: 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

  49. Maximal value of EMG for Soleus (μv)

    Time frame: Day 0

    Patients of the 3 groups

  50. Maximal value of EMG for Soleus (μv)

    Time frame: Day 7

    Patients included in the "hospitalization group"

  51. Maximal value of EMG for Soleus (μv)

    Time frame: 30minutes to 2 hours after an anesthesic block

    Patients included in the "treatment group" and treated by anesthesic block

  52. Maximal value of EMG for Soleus (μv)

    Time frame: 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

  53. score on the modified Asworth scale

    Time frame: Day 0

    Patients of the 3 groups

  54. modified Tardieu scale assigned by the evaluator

    Time frame: Day 0

    Patients of the 3 groups

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Collaborators

  • Compiègne University of Technology

Registry information

Acronym: MSPMI

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 11, 2017
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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