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

November 26, 2020 updated by: Nantes University Hospital

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Nantes, France, 44000
        • Médecine Physique et Réadaptation Neurologique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Simple Assessment group
Intervention is a single evaluation with the MSPMI by two evaluators.
Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
EXPERIMENTAL: Hospitalization group
Evaluation with the MSPMI by two evaluators on two consultations separate by a 7 days interval.
Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
EXPERIMENTAL: Treatment group
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).
Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Brigitte Perrouin-Verbe, PU-PH, Nantes CHU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2017

Primary Completion (ACTUAL)

September 10, 2019

Study Completion (ACTUAL)

March 13, 2020

Study Registration Dates

First Submitted

August 29, 2017

First Submitted That Met QC Criteria

October 5, 2017

First Posted (ACTUAL)

October 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2020

Last Update Submitted That Met QC Criteria

November 26, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spasticity, Muscle

Clinical Trials on single assessment with the MSPMI

Subscribe