Spasticity, MuscleMSPMINCT03307135
Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity
A study testing single assessment with the MSPMI, double assessment with the MSPMI with 7 days of interval and double assessment with the MSPMI before and after treatment in people with Spasticity, Muscle, run by Nantes University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spasticity, Muscle
- What is being tested?
- single assessment with the MSPMI, double assessment with the MSPMI with 7 days of interval and double assessment with the MSPMI before and after treatment
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2017to 13 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Spasticity with respect to the Lance defintion (minimal score of 1 on the modified Ashworth scale)
Who cannot join
- Contraindication of ankle manipulation : fracture, phlebitis, bedsore
- amyotrophic lateral sclerosis
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Spasticity, Muscle
- Being tested
- single assessment with the MSPMI, double assessment with the MSPMI with 7 days of interval, double assessment with the MSPMI before and after treatment
- Keywords
- Spasticity, electrophysiology, biomechanics, objective assessment
- Medical subject headings
- Muscle Spasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single assessment with the MSPMIDevice
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 intervalDevice
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 treatmentDevice
Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
| Study group | Role | What they receive |
|---|---|---|
| Simple Assessment group | Experimental | Intervention is a single evaluation with the MSPMI by two evaluators. Receives: 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. Receives: 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). Receives: Device: double assessment with the MSPMI before and after treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of the mobilization reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Measured: Day 0
range of motion (degree) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Measured: Day 0
maximal angular speed (degree.sec-1) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Measured: Day 0
torque peaque (N.m) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Measured: Day 0
work variability index (mJ.sec) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Measured: Day 0
area under the curve raw Work = f(time) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Measured: Day 0
area under the curve rectified Work = f(time) (J.sec) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Measured: 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
Measured: Day 0
Raw rectified EMG for Soleus (μv) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Measured: Day 0
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Measured: Day 0
Averaged rectified EMG for Soleus (μv.sec-1) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Measured: Day 0
Maximal value of EMG for Gastrocnemius medialis (μv) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Measured: Day 0
Maximal value of EMG for Soleus (μv) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Measured: Day 0
Secondary outcomes (54)
duration of the mobilization (sec)
Patients of the 3 groups
Measured: Day0
duration of the mobilization (sec),
Patients included in the "hospitalization group"
Measured: Day7
duration of the mobilization (sec),
Patients included in the "treatment group" and treated by anesthesic block
Measured: 30minutes to 2 hours after an anesthesic block
duration of the mobilization (sec),
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Measured: 2 to 3 months after neurotomy or botulinium toxin injection
range of motion (degree),
Patients of the 3 groups
Measured: Day0
range of motion (degree),
Patients included in the "hospitalization group"
Measured: Day7
range of motion (degree),
Patients included in the "treatment group" and treated by anesthesic block
Measured: 30minutes to 2 hours after an anesthesic block
range of motion (degree),
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Measured: 2 to 3 months after neurotomy or botulinium toxin injection
maximal angular speed (degree.sec-1)
Patients of the 3 groups
Measured: Day 0
maximal angular speed (degree.sec-1)
Patients included in the "hospitalization group"
Measured: Day 7
maximal angular speed (degree.sec-1)
Patients included in the "treatment group" and treated by anesthesic block
Measured: 30minutes to 2 hours after an anesthesic block
maximal angular speed (degree.sec-1)
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Measured: 2 to 3 months after neurotomy or botulinium toxin injection
torque peaque (N.m)
Patients of the 3 groups
Measured: Day 0
torque peaque (N.m)
Patients included in the "hospitalization group"
Measured: Day 7
torque peaque (N.m)
Patients included in the "treatment group" and treated by anesthesic block
Measured: 30minutes to 2 hours after an anesthesic block
torque peaque (N.m)
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Measured: 2 to 3 months after neurotomy or botulinium toxin injection
work variability index (mJ.sec)
Patients of the 3 groups
Measured: Day0
work variability index (mJ.sec)
Patients included in the "hospitalization group"
Measured: Day7
work variability index (mJ.sec)
Patients included in the "treatment group" and treated by anesthesic block
Measured: 30minutes to 2 hours after an anesthesic block
work variability index (mJ.sec)
Measured: 2 to 3 months after neurotomy or botulinium toxin injection
area under the curve raw Work = f(time)
Patients of the 3 groups
Measured: Day 0
area under the curve raw Work = f(time)
Patients included in the "hospitalization group"
Measured: Day 7
area under the curve raw Work = f(time)
Patients included in the "treatment group" and treated by anesthesic block
Measured: 30minutes to 2 hours after an anesthesic block
area under the curve raw Work = f(time)
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Measured: 2 to 3 months after neurotomy or botulinium toxin injection
area under the curve rectified Work = f(time) (J.sec)
Patients of the 3 groups
Measured: Day 0
area under the curve rectified Work = f(time) (J.sec)
Patients included in the "hospitalization group"
Measured: Day 7
area under the curve rectified Work = f(time) (J.sec)
Patients included in the "treatment group" and treated by anesthesic block
Measured: 30minutes to 2 hours after an anesthesic block
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
Measured: 2 to 3 months after neurotomy or botulinium toxin injection
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Patients of the 3 groups
Measured: Day 0
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Patients included in the "hospitalization group"
Measured: Day 7
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Patients included in the "treatment group" and treated by anesthesic block
Measured: 30minutes to 2 hours after an anesthesic block
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
Measured: 2 to 3 months after neurotomy or botulinium toxin injection
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Patients of the 3 groups
Measured: Day0
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Patients included in the "hospitalization group"
Measured: Day7
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Patients included in the "treatment group" and treated by anesthesic block
Measured: 30minutes to 2 hours after an anesthesic block
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
Measured: 2 to 3 months after neurotomy or botulinium toxin injection
Raw rectified EMG for Soleus (μv)
Patients of the 3 groups
Measured: Day 0
Raw rectified EMG for Soleus (μv)
Patients included in the "hospitalization group"
Measured: Day 7
Raw rectified EMG for Soleus (μv)
Patients included in the "treatment group" and treated by anesthesic block
Measured: 30minutes to 2 hours after an anesthesic block
Raw rectified EMG for Soleus (μv)
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Measured: 2 to 3 months after neurotomy or botulinium toxin injection
Averaged rectified EMG for Soleus (μv.sec-1)
Patients of the 3 groups
Measured: Day 0
Averaged rectified EMG for Soleus (μv.sec-1)
Patients included in the "hospitalization group"
Measured: Day 7
Averaged rectified EMG for Soleus (μv.sec-1)
Patients included in the "treatment group" and treated by anesthesic block
Measured: 30minutes to 2 hours after an anesthesic block
Averaged rectified EMG for Soleus (μv.sec-1)
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Measured: 2 to 3 months after neurotomy or botulinium toxin injection
maximal value of EMG for Gastrocnemius medialis (μV)
Patients of the 3 groups
Measured: Day0
maximal value of EMG for Gastrocnemius medialis (μV)
Patients included in the "hospitalization group"
Measured: Day7
maximal value of EMG for Gastrocnemius medialis (μV)
Patients included in the "treatment group" and treated by anesthesic block
Measured: 30minutes to 2 hours after an anesthesic block
maximal value of EMG for Gastrocnemius medialis (μV)
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Measured: 2 to 3 months after neurotomy or botulinium toxin injection
Maximal value of EMG for Soleus (μv)
Patients of the 3 groups
Measured: Day 0
Maximal value of EMG for Soleus (μv)
Patients included in the "hospitalization group"
Measured: Day 7
Maximal value of EMG for Soleus (μv)
Patients included in the "treatment group" and treated by anesthesic block
Measured: 30minutes to 2 hours after an anesthesic block
Maximal value of EMG for Soleus (μv)
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Measured: 2 to 3 months after neurotomy or botulinium toxin injection
score on the modified Asworth scale
Patients of the 3 groups
Measured: Day 0
modified Tardieu scale assigned by the evaluator
Patients of the 3 groups
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start10 Oct 2017
- Primary completion10 Sep 2019
- Study completion13 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spasticity, MuscleStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Compiègne University of Technology
- Responsible party
- Sponsor
- Investigators
- Brigitte Perrouin-Verbe, PU-PH, Principal investigator, Nantes CHU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03307135
- Sponsor's protocol ID
- RC17_0028
- Acronym
- MSPMI
- Status last verified
- Nov 2020
- First submitted
- 29 Aug 2017
- Last updated
- 30 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 23791154Bar-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.
PubMed 23994052de 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.
PubMed 20663189Schless 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.
PubMed 26134673Gaverth 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.
PubMed 23695917Turk 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.
PubMed 18776066
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity
- ClinicalTrials.gov ID
- NCT03307135
- Acronym / sponsor ID
- MSPMI / RC17_0028
- Conditions
- Spasticity, Muscle
- Keywords
- Spasticity, electrophysiology, biomechanics, objective assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Compiègne University of Technology
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- 10 Sep 2019 (actual)
- Study completion
- 13 Mar 2020 (actual)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simple Assessment group | Experimental | Device: single assessment with the MSPMIIntervention is a single evaluation with the MSPMI by two evaluators. |
| Hospitalization group | Experimental | Device: double assessment with the MSPMI with 7 days of intervalEvaluation with the MSPMI by two evaluators on two consultations separate by a 7 days interval. |
| Treatment group | Experimental | Device: double assessment with the MSPMI before and after treatmentEvaluation 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Spasticity with respect to the Lance defintion (minimal score of 1 on the modified Ashworth scale)
Key exclusion criteria (2 listed)
- Contraindication of ankle manipulation : fracture, phlebitis, bedsore
- amyotrophic lateral sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| single assessment with the MSPMIManually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended) | Device | Simple Assessment group |
| double assessment with the MSPMI with 7 days of intervalManually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended) | Device | Hospitalization group |
| double assessment with the MSPMI before and after treatmentManually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended) | Device | Treatment group |
Primary outcome
Duration of the mobilization reproductibility coefficient
Time frame: Day 0
inter-rater intra-session reproductibility coefficient
range of motion (degree) reproductibility coefficient
Time frame: Day 0
inter-rater intra-session reproductibility coefficient
maximal angular speed (degree.sec-1) reproductibility coefficient
Time frame: Day 0
inter-rater intra-session reproductibility coefficient
torque peaque (N.m) reproductibility coefficient
Time frame: Day 0
inter-rater intra-session reproductibility coefficient
work variability index (mJ.sec) reproductibility coefficient
Time frame: Day 0
inter-rater intra-session reproductibility coefficient
area under the curve raw Work = f(time) reproductibility coefficient
Time frame: Day 0
inter-rater intra-session reproductibility coefficient
area under the curve rectified Work = f(time) (J.sec) reproductibility coefficient
Time frame: Day 0
inter-rater intra-session reproductibility coefficient
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
Raw rectified EMG for Soleus (μv) reproductibility coefficient
Time frame: Day 0
inter-rater intra-session reproductibility coefficient
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) reproductibility coefficient
Time frame: Day 0
inter-rater intra-session reproductibility coefficient
Averaged rectified EMG for Soleus (μv.sec-1) reproductibility coefficient
Time frame: Day 0
inter-rater intra-session reproductibility coefficient
Maximal value of EMG for Gastrocnemius medialis (μv) reproductibility coefficient
Time frame: Day 0
inter-rater intra-session reproductibility coefficient
Maximal value of EMG for Soleus (μv) reproductibility coefficient
Time frame: Day 0
inter-rater intra-session reproductibility coefficient
54 secondary outcomes
duration of the mobilization (sec)
Time frame: Day0
duration of the mobilization (sec),
Time frame: Day7
duration of the mobilization (sec),
Time frame: 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
range of motion (degree),
Time frame: Day0
range of motion (degree),
Time frame: Day7
range of motion (degree),
Time frame: 30minutes to 2 hours after an anesthesic block
range of motion (degree),
Time frame: 2 to 3 months after neurotomy or botulinium toxin injection
maximal angular speed (degree.sec-1)
Time frame: Day 0
maximal angular speed (degree.sec-1)
Time frame: Day 7
maximal angular speed (degree.sec-1)
Time frame: 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
torque peaque (N.m)
Time frame: Day 0
torque peaque (N.m)
Time frame: Day 7
torque peaque (N.m)
Time frame: 30minutes to 2 hours after an anesthesic block
torque peaque (N.m)
Time frame: 2 to 3 months after neurotomy or botulinium toxin injection
work variability index (mJ.sec)
Time frame: Day0
work variability index (mJ.sec)
Time frame: Day7
work variability index (mJ.sec)
Time frame: 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
area under the curve raw Work = f(time)
Time frame: Day 0
area under the curve raw Work = f(time)
Time frame: Day 7
area under the curve raw Work = f(time)
Time frame: 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
area under the curve rectified Work = f(time) (J.sec)
Time frame: Day 0
area under the curve rectified Work = f(time) (J.sec)
Time frame: Day 7
area under the curve rectified Work = f(time) (J.sec)
Time frame: 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
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Time frame: Day 0
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Time frame: Day 7
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Time frame: 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
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Time frame: Day0
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Time frame: Day7
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Time frame: 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
Raw rectified EMG for Soleus (μv)
Time frame: Day 0
Raw rectified EMG for Soleus (μv)
Time frame: Day 7
Raw rectified EMG for Soleus (μv)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Background: PubMed 23791154Bar-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.
- Background: PubMed 23994052Bar-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.
- Background: PubMed 20663189de 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.
- Background: PubMed 26134673Schless 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.
- Background: PubMed 23695917Gaverth 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.
- Background: PubMed 18776066Turk 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brigitte Perrouin-Verbe, PU-PH principal investigator
Nantes CHU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing single assessment with the MSPMI, double assessment with the MSPMI with 7 days of interval and double assessment with the MSPMI before and after treatment in people with Spasticity, Muscle, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of the mobilization reproductibility coefficient (time frame: Day 0). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03307135, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2020.