Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03307135
Other study ID # RC17_0028
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Completed NCT03908580 - MEDITOXIN® Treatment in Subjects With Post-Stroke Upper Limb Spasticity Phase 4
Not yet recruiting NCT04550793 - Using Shear Wave Ultrasound Elastography for Follow up After Anti-spastic Intervention Among Stroke Patients
Recruiting NCT05432999 - Extracorporeal Shockwave Therapy for Spasticity in People With Spinal Cord Injury N/A
Completed NCT05687097 - Untreated Sleep Apnea as an Aggravating Factor for Other Secondary Medical Conditions After Spinal Cord Injury
Active, not recruiting NCT05562453 - Performance and Long-term Safety of FlowOx2.0™ in Patients With Multiple Sclerosis - Impact on Spasticity and Pain N/A
Recruiting NCT06214975 - EXOPULSE Mollii Suit, Motor Function & Stroke (EXOSTROKE 2) N/A
Recruiting NCT05464160 - Focal Muscular Vibration in Patients With Severe Acquired Brain Injury N/A
Completed NCT04130295 - Influence of Wearable Intensive Nerve Stimulation on Spasticity and Function in Persons With Spinal Cord Injury N/A
Recruiting NCT06070233 - Radiosurgery Treatment for Spasticity Associated With Stroke, SCI & Cerebral Palsy N/A
Completed NCT03747900 - Dry Needling and Botulinum Toxin in the Management of Poststroke Spasticity N/A
Recruiting NCT05070780 - Neurophysiological Evaluation of Muscle Tone
Recruiting NCT04620707 - RGS@Home: Personalized 24/7 Home Care Post-stroke N/A
Recruiting NCT06109129 - Investıgatıon Of The Effectıveness Of The Mollıı Suıt In Chıldren Wıth Ambulatory Cerebral Palsy N/A
Enrolling by invitation NCT05598736 - Performance and Long-term Safety of FlowOx2.0™, Multiple Sclerosis, Spasticity and Pain N/A
Completed NCT05103202 - Efficacy and Safety of 10-Week or Shorter vs 12-Week or Longer Injection Intervals of Botulinum Toxin
Active, not recruiting NCT05626790 - Effects of PNF and Static Stretching on Architecture and Viscoelastic Properties of Hemiplegic Elbow N/A
Recruiting NCT04904016 - Pilot Investigation to Evaluate FlowOx2.0™ for Experimental Treatment of Spasticity N/A
Withdrawn NCT05887479 - The Effect of Ultrasound-Guided Botulinum Toxin Injections on Pain, Functionality, Spasticity, and Range of Motion in Patients With Post-Stroke Upper Extremity Spasticity Phase 4
Completed NCT03442660 - Validation of the Spasticity Related Quality of Life Questionnaire N/A

External Links