- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03307135
Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity (MSPMI)
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
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Nantes, France, 44000
- Médecine Physique et Réadaptation Neurologique
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Brigitte Perrouin-Verbe, PU-PH, Nantes CHU
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Helpful Links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC17_0028
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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