Ignite Creation Date:
2024-05-06 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05070780
Status:
RECRUITING
Last Update Posted:
2023-03-22
First Post:
2021-09-27
Brief Title:
Neurophysiological Evaluation of Muscle Tone
Sponsor:
Neuromed IRCCS
Organization:
Neuromed IRCCS
Study Overview
Official Title:
Neurophysiological Evaluation of Muscle Tone in Healthy Subjects and in Patients With Increased Muscle Tone
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to apply a biomechanical system the NeuroFlexor associated with the EMG recording to study the physiological mechanisms that contribute to the regulation of muscle tone in healthy subjects and in patients with increased muscle tone A second fundamental objective of this study is to monitor over time the changes in muscle tone that can be found physiologically in healthy subjects and pathologically in patients with spasticy andor rigidity A further objective of this study is the quantitative evaluation of the symptomatic effects of specific therapies in improving the impaired muscle tone
Clinical evaluation In this research project the investigators will recruit 20 patients with upper limb spasticity regardless of the underlying disease responsible for the spasticity 20 patients with Parkinsons disease characterized by stiffness of the upper limbs and 20 healthy control subjects Patients will be recruited from the IRCCS Neuromed Institute Pozzilli IS Participants will give their written informed consent to the study which will be approved by the institutional ethics committee of the IRCCS Neuromed Institute in accordance with the Declaration of Helsinki All participants will be right-handed according to the Edinburgh handedness inventory EDI Oldfield 1971 Parkinsons disease will be diagnosed in accordance with the updated diagnostic criteria of the MDS Postuma RB et al Validation of the MDS clinical diagnostic criteria for Parkinsons disease Mov Disord Off J Mov Disord Soc 33 1601 -1608 2018 Nd Clinical signs and symptoms of parkinsonian patients will be evaluated using the Hoehn Yahr scale HY UPDRS part III Patrick et al 2001 The diagnosis of spasticity will be made through the neurological clinical evaluation of the patients and on the basis of the specific clinical history of the various pathologies underlying the spasticity itself eg multiple sclerosis stroke spinal injuries Spasticity will be assessed with the Modified Ashworth Scale MAS Harb and Kishner 2021 the Modified Tardieu scale MTS Patrick and Ada 2006 Cognitive functions and mood in both pathological conditions will be evaluated using the clinical Mini-Mental State Evaluation MMSE scale Folstein et al 1975 and the Hamilton Depression Rating Scale HAM_D Hamilton 1967 No participant must report pain problems and or functional limitations affecting the upper limbs
Exclusion criteria - insufficient degree of passive wrist movement 30 in flexion and 40 in extension - tension at rest during NeuroFlexor recordings - hand pathologies neurological or rheumatological - upper limb fractures in the previous six months - presence of peacemakers or other stimulators - pregnancy
All patients and the group of healthy control subjects will have comparable anthropometric and demographic characteristics
Experimental paradigm Participants will be seated comfortably with the shoulder at 45 of abduction the elbow at 90 in flexion the forearm in pronation and the dominant hand placed on the platform of the Neuroflexor device Participants will be instructed to relax during the test session which will consist of the passive extension of the wrist at 7 speeds one slow 5 s and 6 rapid 50 s 100 s 150 s 200 s 236 s 280 s The total range of wrist movement will be 50 starting from an initial angle of 20 in palmar flexion up to 30 in extension Before the start of the experiment participants will do practical tests in order to become familiar with the device Two slow and five rapid movements will be made for each speed The different angular velocities of wrist mobilization will be randomized Slow movements will be performed before fast movements with an interval of 10 seconds between each test For each participant a NC EC and VC value in Newton will be calculated by a dedicated software The resistance profiles will also be obtained when the device was running idle without hand to allow the biomechanical model to isolate the forces originating from the hand from the intrinsic forces of the device For each movement the corresponding surface EMG trace will have been recorded by placing the electrodes on the skin overlying the belly of the FRC and ERC muscles An accelerometer fixed on the back of the hand of the limb to be examined will be used to synchronize the electromyograph with the NeuroFlexor The EMG activity recorded by means of surface electrodes with belly-tendon type mounting will be amplified using the Digitimer will then be digitized at 5 kHz using the CED and finally it will be stored on a computer dedicated to offline analysis EMG recordings will be made at 6 speeds 50 s 100 s 150 s 200 s 236 s 280 s For each trace the following parameters will be analyzed latency peak-to-peak amplitude and area of the EMG response
Clinical evaluation In this research project the investigators will recruit 20 patients with upper limb spasticity regardless of the underlying disease responsible for the spasticity 20 patients with Parkinsons disease characterized by stiffness of the upper limbs and 20 healthy control subjects Patients will be recruited from the IRCCS Neuromed Institute Pozzilli IS Participants will give their written informed consent to the study which will be approved by the institutional ethics committee of the IRCCS Neuromed Institute in accordance with the Declaration of Helsinki All participants will be right-handed according to the Edinburgh handedness inventory EDI Oldfield 1971 Parkinsons disease will be diagnosed in accordance with the updated diagnostic criteria of the MDS Postuma RB et al Validation of the MDS clinical diagnostic criteria for Parkinsons disease Mov Disord Off J Mov Disord Soc 33 1601 -1608 2018 Nd Clinical signs and symptoms of parkinsonian patients will be evaluated using the Hoehn Yahr scale HY UPDRS part III Patrick et al 2001 The diagnosis of spasticity will be made through the neurological clinical evaluation of the patients and on the basis of the specific clinical history of the various pathologies underlying the spasticity itself eg multiple sclerosis stroke spinal injuries Spasticity will be assessed with the Modified Ashworth Scale MAS Harb and Kishner 2021 the Modified Tardieu scale MTS Patrick and Ada 2006 Cognitive functions and mood in both pathological conditions will be evaluated using the clinical Mini-Mental State Evaluation MMSE scale Folstein et al 1975 and the Hamilton Depression Rating Scale HAM_D Hamilton 1967 No participant must report pain problems and or functional limitations affecting the upper limbs
Exclusion criteria - insufficient degree of passive wrist movement 30 in flexion and 40 in extension - tension at rest during NeuroFlexor recordings - hand pathologies neurological or rheumatological - upper limb fractures in the previous six months - presence of peacemakers or other stimulators - pregnancy
All patients and the group of healthy control subjects will have comparable anthropometric and demographic characteristics
Experimental paradigm Participants will be seated comfortably with the shoulder at 45 of abduction the elbow at 90 in flexion the forearm in pronation and the dominant hand placed on the platform of the Neuroflexor device Participants will be instructed to relax during the test session which will consist of the passive extension of the wrist at 7 speeds one slow 5 s and 6 rapid 50 s 100 s 150 s 200 s 236 s 280 s The total range of wrist movement will be 50 starting from an initial angle of 20 in palmar flexion up to 30 in extension Before the start of the experiment participants will do practical tests in order to become familiar with the device Two slow and five rapid movements will be made for each speed The different angular velocities of wrist mobilization will be randomized Slow movements will be performed before fast movements with an interval of 10 seconds between each test For each participant a NC EC and VC value in Newton will be calculated by a dedicated software The resistance profiles will also be obtained when the device was running idle without hand to allow the biomechanical model to isolate the forces originating from the hand from the intrinsic forces of the device For each movement the corresponding surface EMG trace will have been recorded by placing the electrodes on the skin overlying the belly of the FRC and ERC muscles An accelerometer fixed on the back of the hand of the limb to be examined will be used to synchronize the electromyograph with the NeuroFlexor The EMG activity recorded by means of surface electrodes with belly-tendon type mounting will be amplified using the Digitimer will then be digitized at 5 kHz using the CED and finally it will be stored on a computer dedicated to offline analysis EMG recordings will be made at 6 speeds 50 s 100 s 150 s 200 s 236 s 280 s For each trace the following parameters will be analyzed latency peak-to-peak amplitude and area of the EMG response
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None