Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity (MSPMI)
Primary Purpose
Spasticity, Muscle
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
single assessment with the MSPMI
double assessment with the MSPMI with 7 days of interval
double assessment with the MSPMI before and after treatment
Sponsored by
About this trial
This is an interventional other trial for Spasticity, Muscle focused on measuring Spasticity, electrophysiology, biomechanics, objective assessment
Eligibility Criteria
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
Sites / Locations
- Médecine Physique et Réadaptation Neurologique
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Simple Assessment group
Hospitalization group
Treatment group
Arm Description
Intervention is a single evaluation with the MSPMI by two evaluators.
Evaluation with the MSPMI by two evaluators on two consultations separate by a 7 days interval.
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).
Outcomes
Primary Outcome Measures
Duration of the mobilization reproductibility coefficient
inter-rater intra-session reproductibility coefficient
range of motion (degree) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
maximal angular speed (degree.sec-1) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
torque peaque (N.m) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
work variability index (mJ.sec) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
area under the curve raw Work = f(time) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
area under the curve rectified Work = f(time) (J.sec) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
raw and averaged rectified EMG for Soleus and Gastrocnemius medialis (μV and μV.sec-1) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Raw rectified EMG for Soleus (μv) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Averaged rectified EMG for Soleus (μv.sec-1) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Maximal value of EMG for Gastrocnemius medialis (μv) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Maximal value of EMG for Soleus (μv) reproductibility coefficient
inter-rater intra-session reproductibility coefficient
Secondary Outcome Measures
duration of the mobilization (sec)
Patients of the 3 groups
duration of the mobilization (sec),
Patients included in the "hospitalization group"
duration of the mobilization (sec),
Patients included in the "treatment group" and treated by anesthesic block
duration of the mobilization (sec),
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
range of motion (degree),
Patients of the 3 groups
range of motion (degree),
Patients included in the "hospitalization group"
range of motion (degree),
Patients included in the "treatment group" and treated by anesthesic block
range of motion (degree),
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
maximal angular speed (degree.sec-1)
Patients of the 3 groups
maximal angular speed (degree.sec-1)
Patients included in the "hospitalization group"
maximal angular speed (degree.sec-1)
Patients included in the "treatment group" and treated by anesthesic block
maximal angular speed (degree.sec-1)
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
torque peaque (N.m)
Patients of the 3 groups
torque peaque (N.m)
Patients included in the "hospitalization group"
torque peaque (N.m)
Patients included in the "treatment group" and treated by anesthesic block
torque peaque (N.m)
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
work variability index (mJ.sec)
Patients of the 3 groups
work variability index (mJ.sec)
Patients included in the "hospitalization group"
work variability index (mJ.sec)
Patients included in the "treatment group" and treated by anesthesic block
work variability index (mJ.sec)
area under the curve raw Work = f(time)
Patients of the 3 groups
area under the curve raw Work = f(time)
Patients included in the "hospitalization group"
area under the curve raw Work = f(time)
Patients included in the "treatment group" and treated by 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
area under the curve rectified Work = f(time) (J.sec)
Patients of the 3 groups
area under the curve rectified Work = f(time) (J.sec)
Patients included in the "hospitalization group"
area under the curve rectified Work = f(time) (J.sec)
Patients included in the "treatment group" and treated by 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
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Patients of the 3 groups
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Patients included in the "hospitalization group"
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Patients included in the "treatment group" and treated by 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
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Patients of the 3 groups
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Patients included in the "hospitalization group"
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Patients included in the "treatment group" and treated by 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
Raw rectified EMG for Soleus (μv)
Patients of the 3 groups
Raw rectified EMG for Soleus (μv)
Patients included in the "hospitalization group"
Raw rectified EMG for Soleus (μv)
Patients included in the "treatment group" and treated by anesthesic block
Raw rectified EMG for Soleus (μv)
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Averaged rectified EMG for Soleus (μv.sec-1)
Patients of the 3 groups
Averaged rectified EMG for Soleus (μv.sec-1)
Patients included in the "hospitalization group"
Averaged rectified EMG for Soleus (μv.sec-1)
Patients included in the "treatment group" and treated by 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
maximal value of EMG for Gastrocnemius medialis (μV)
Patients of the 3 groups
maximal value of EMG for Gastrocnemius medialis (μV)
Patients included in the "hospitalization group"
maximal value of EMG for Gastrocnemius medialis (μV)
Patients included in the "treatment group" and treated by 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
Maximal value of EMG for Soleus (μv)
Patients of the 3 groups
Maximal value of EMG for Soleus (μv)
Patients included in the "hospitalization group"
Maximal value of EMG for Soleus (μv)
Patients included in the "treatment group" and treated by 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
score on the modified Asworth scale
Patients of the 3 groups
modified Tardieu scale assigned by the evaluator
Patients of the 3 groups
Full Information
NCT ID
NCT03307135
First Posted
August 29, 2017
Last Updated
November 26, 2020
Sponsor
Nantes University Hospital
Collaborators
Compiègne University of Technology
1. Study Identification
Unique Protocol Identification Number
NCT03307135
Brief Title
Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity
Acronym
MSPMI
Official Title
Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
September 10, 2019 (Actual)
Study Completion Date
March 13, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
Collaborators
Compiègne University of Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasticity, Muscle
Keywords
Spasticity, electrophysiology, biomechanics, objective assessment
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simple Assessment group
Arm Type
Experimental
Arm Description
Intervention is a single evaluation with the MSPMI by two evaluators.
Arm Title
Hospitalization group
Arm Type
Experimental
Arm Description
Evaluation with the MSPMI by two evaluators on two consultations separate by a 7 days interval.
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
single assessment with the MSPMI
Intervention Description
Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
Intervention Type
Device
Intervention Name(s)
double assessment with the MSPMI with 7 days of interval
Intervention Description
Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
Intervention Type
Device
Intervention Name(s)
double assessment with the MSPMI before and after treatment
Intervention Description
Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
Primary Outcome Measure Information:
Title
Duration of the mobilization reproductibility coefficient
Description
inter-rater intra-session reproductibility coefficient
Time Frame
Day 0
Title
range of motion (degree) reproductibility coefficient
Description
inter-rater intra-session reproductibility coefficient
Time Frame
Day 0
Title
maximal angular speed (degree.sec-1) reproductibility coefficient
Description
inter-rater intra-session reproductibility coefficient
Time Frame
Day 0
Title
torque peaque (N.m) reproductibility coefficient
Description
inter-rater intra-session reproductibility coefficient
Time Frame
Day 0
Title
work variability index (mJ.sec) reproductibility coefficient
Description
inter-rater intra-session reproductibility coefficient
Time Frame
Day 0
Title
area under the curve raw Work = f(time) reproductibility coefficient
Description
inter-rater intra-session reproductibility coefficient
Time Frame
Day 0
Title
area under the curve rectified Work = f(time) (J.sec) reproductibility coefficient
Description
inter-rater intra-session reproductibility coefficient
Time Frame
Day 0
Title
raw and averaged rectified EMG for Soleus and Gastrocnemius medialis (μV and μV.sec-1) reproductibility coefficient
Description
inter-rater intra-session reproductibility coefficient
Time Frame
Day 0
Title
Raw rectified EMG for Soleus (μv) reproductibility coefficient
Description
inter-rater intra-session reproductibility coefficient
Time Frame
Day 0
Title
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1) reproductibility coefficient
Description
inter-rater intra-session reproductibility coefficient
Time Frame
Day 0
Title
Averaged rectified EMG for Soleus (μv.sec-1) reproductibility coefficient
Description
inter-rater intra-session reproductibility coefficient
Time Frame
Day 0
Title
Maximal value of EMG for Gastrocnemius medialis (μv) reproductibility coefficient
Description
inter-rater intra-session reproductibility coefficient
Time Frame
Day 0
Title
Maximal value of EMG for Soleus (μv) reproductibility coefficient
Description
inter-rater intra-session reproductibility coefficient
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
duration of the mobilization (sec)
Description
Patients of the 3 groups
Time Frame
Day0
Title
duration of the mobilization (sec),
Description
Patients included in the "hospitalization group"
Time Frame
Day7
Title
duration of the mobilization (sec),
Description
Patients included in the "treatment group" and treated by anesthesic block
Time Frame
30minutes to 2 hours after an anesthesic block
Title
duration of the mobilization (sec),
Description
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Time Frame
2 to 3 months after neurotomy or botulinium toxin injection
Title
range of motion (degree),
Description
Patients of the 3 groups
Time Frame
Day0
Title
range of motion (degree),
Description
Patients included in the "hospitalization group"
Time Frame
Day7
Title
range of motion (degree),
Description
Patients included in the "treatment group" and treated by anesthesic block
Time Frame
30minutes to 2 hours after an anesthesic block
Title
range of motion (degree),
Description
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Time Frame
2 to 3 months after neurotomy or botulinium toxin injection
Title
maximal angular speed (degree.sec-1)
Description
Patients of the 3 groups
Time Frame
Day 0
Title
maximal angular speed (degree.sec-1)
Description
Patients included in the "hospitalization group"
Time Frame
Day 7
Title
maximal angular speed (degree.sec-1)
Description
Patients included in the "treatment group" and treated by anesthesic block
Time Frame
30minutes to 2 hours after an anesthesic block
Title
maximal angular speed (degree.sec-1)
Description
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Time Frame
2 to 3 months after neurotomy or botulinium toxin injection
Title
torque peaque (N.m)
Description
Patients of the 3 groups
Time Frame
Day 0
Title
torque peaque (N.m)
Description
Patients included in the "hospitalization group"
Time Frame
Day 7
Title
torque peaque (N.m)
Description
Patients included in the "treatment group" and treated by anesthesic block
Time Frame
30minutes to 2 hours after an anesthesic block
Title
torque peaque (N.m)
Description
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Time Frame
2 to 3 months after neurotomy or botulinium toxin injection
Title
work variability index (mJ.sec)
Description
Patients of the 3 groups
Time Frame
Day0
Title
work variability index (mJ.sec)
Description
Patients included in the "hospitalization group"
Time Frame
Day7
Title
work variability index (mJ.sec)
Description
Patients included in the "treatment group" and treated by anesthesic block
Time Frame
30minutes to 2 hours after an anesthesic block
Title
work variability index (mJ.sec)
Time Frame
2 to 3 months after neurotomy or botulinium toxin injection
Title
area under the curve raw Work = f(time)
Description
Patients of the 3 groups
Time Frame
Day 0
Title
area under the curve raw Work = f(time)
Description
Patients included in the "hospitalization group"
Time Frame
Day 7
Title
area under the curve raw Work = f(time)
Description
Patients included in the "treatment group" and treated by anesthesic block
Time Frame
30minutes to 2 hours after an anesthesic block
Title
area under the curve raw Work = f(time)
Description
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Time Frame
2 to 3 months after neurotomy or botulinium toxin injection
Title
area under the curve rectified Work = f(time) (J.sec)
Description
Patients of the 3 groups
Time Frame
Day 0
Title
area under the curve rectified Work = f(time) (J.sec)
Description
Patients included in the "hospitalization group"
Time Frame
Day 7
Title
area under the curve rectified Work = f(time) (J.sec)
Description
Patients included in the "treatment group" and treated by anesthesic block
Time Frame
30minutes to 2 hours after an anesthesic block
Title
area under the curve rectified Work = f(time) (J.sec)
Description
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Time Frame
2 to 3 months after neurotomy or botulinium toxin injection
Title
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Description
Patients of the 3 groups
Time Frame
Day 0
Title
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Description
Patients included in the "hospitalization group"
Time Frame
Day 7
Title
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Description
Patients included in the "treatment group" and treated by anesthesic block
Time Frame
30minutes to 2 hours after an anesthesic block
Title
raw rectified EMG for Gastrocnemius medialis (μV and μV.sec-1)
Description
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Time Frame
2 to 3 months after neurotomy or botulinium toxin injection
Title
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Description
Patients of the 3 groups
Time Frame
Day0
Title
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Description
Patients included in the "hospitalization group"
Time Frame
Day7
Title
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Description
Patients included in the "treatment group" and treated by anesthesic block
Time Frame
30minutes to 2 hours after an anesthesic block
Title
Averaged rectified EMG for Gastrocnemius medialis (μv.sec-1)
Description
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Time Frame
2 to 3 months after neurotomy or botulinium toxin injection
Title
Raw rectified EMG for Soleus (μv)
Description
Patients of the 3 groups
Time Frame
Day 0
Title
Raw rectified EMG for Soleus (μv)
Description
Patients included in the "hospitalization group"
Time Frame
Day 7
Title
Raw rectified EMG for Soleus (μv)
Description
Patients included in the "treatment group" and treated by anesthesic block
Time Frame
30minutes to 2 hours after an anesthesic block
Title
Raw rectified EMG for Soleus (μv)
Description
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Time Frame
2 to 3 months after neurotomy or botulinium toxin injection
Title
Averaged rectified EMG for Soleus (μv.sec-1)
Description
Patients of the 3 groups
Time Frame
Day 0
Title
Averaged rectified EMG for Soleus (μv.sec-1)
Description
Patients included in the "hospitalization group"
Time Frame
Day 7
Title
Averaged rectified EMG for Soleus (μv.sec-1)
Description
Patients included in the "treatment group" and treated by anesthesic block
Time Frame
30minutes to 2 hours after an anesthesic block
Title
Averaged rectified EMG for Soleus (μv.sec-1)
Description
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Time Frame
2 to 3 months after neurotomy or botulinium toxin injection
Title
maximal value of EMG for Gastrocnemius medialis (μV)
Description
Patients of the 3 groups
Time Frame
Day0
Title
maximal value of EMG for Gastrocnemius medialis (μV)
Description
Patients included in the "hospitalization group"
Time Frame
Day7
Title
maximal value of EMG for Gastrocnemius medialis (μV)
Description
Patients included in the "treatment group" and treated by anesthesic block
Time Frame
30minutes to 2 hours after an anesthesic block
Title
maximal value of EMG for Gastrocnemius medialis (μV)
Description
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Time Frame
2 to 3 months after neurotomy or botulinium toxin injection
Title
Maximal value of EMG for Soleus (μv)
Description
Patients of the 3 groups
Time Frame
Day 0
Title
Maximal value of EMG for Soleus (μv)
Description
Patients included in the "hospitalization group"
Time Frame
Day 7
Title
Maximal value of EMG for Soleus (μv)
Description
Patients included in the "treatment group" and treated by anesthesic block
Time Frame
30minutes to 2 hours after an anesthesic block
Title
Maximal value of EMG for Soleus (μv)
Description
Patients included in the "treatment group" and treated by selective tibial neurotomy or toxin intramuscular injection
Time Frame
2 to 3 months after neurotomy or botulinium toxin injection
Title
score on the modified Asworth scale
Description
Patients of the 3 groups
Time Frame
Day 0
Title
modified Tardieu scale assigned by the evaluator
Description
Patients of the 3 groups
Time Frame
Day 0
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brigitte Perrouin-Verbe, PU-PH
Organizational Affiliation
Nantes CHU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Médecine Physique et Réadaptation Neurologique
City
Nantes
ZIP/Postal Code
44000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
23791154
Citation
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Results Reference
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18776066
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.
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https://worldwide.espacenet.com/publicationDetails/originalDocument?FT=D&date=20120726&DB=EPODOC&locale=fr_EP&CC=WO&NR=2012098121A1&KC=A1&ND=6#
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Medical Spastic Patient Machine Interface MSPMI : Biomechanical and Electrophysiological Assessment of the Triceps Surae Spasticity
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