Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634225
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Use of Inertial Units in Patient With Multiple Sclerosis IMUSEP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
IMUSEP Use of Inertial Navigation Systems to Detect and Characterize Early Locomotor Disorders in Patients With Multiple Sclerosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMUSEP
Brief Summary:
The goal of this case control study is to evaluate the use of inertial navigation systems to detect and characterize early locomotor disorders in patients with multiple sclerosis MS The study aims to
Validate the contribution and inefficiency indexes obtained by the Trigno Avanti Sensor inertial units in comparison with indexes calculated with 3D motion analysis during walking and tandem in early-stage MS patients
Researchers will compare MS patients to healthy controls
Validate the contribution and inefficiency indexes obtained by the Trigno Avanti Sensor inertial units in comparison with indexes calculated with 3D motion analysis during walking and tandem in early-stage MS patients
Researchers will compare MS patients to healthy controls
Detailed Description:
Multiple Sclerosis MS is a chronic inflammatory disease of the central nervous system and the leading cause of non-traumatic neurological disability in young adults It affects around 100000 people in France and 5000 are newly diagnosed each year It generally begins between the ages of 20 and 40 and mainly affects women sex ratio 3 women1 man
The clinical presentation of MS is highly polymorphic Patients may present with motor deficits sensory disorders spasticity gait disorders balance disorders visual disturbances etc The symptoms that have the greatest impact on patients quality of life in the first 5 years following diagnosis are gait and balance disorders However these early disorders are barely visible on clinical examination and are not highlighted by the balance and gait tests frequently used in routine practice These sub-clinical locomotor disorders are also not taken into account by the Expanded Disability Status Scale EDSS However the discomfort reported by patients is objectified using the Multiple Sclerosis Walking Scale-12 MSWS-12 questionnaire
The management of balance and gait disorders is essential to limit deconditioning during exercise and reduce their impact on patients quality of life Detecting these disorders is therefore a key factor in improving our understanding of them and enabling us to provide appropriate rehabilitation
In the early stages gait and balance disorders can be detected by means of three-dimensional movement analysis
Certain parameters such as contribution and inefficiency indexes have proved useful in detecting and quantifying gait and balance disorders in early-stage MS patients These indexes are based on the calculation of linear moments The contribution index reflects the contribution of each body segment to body forward motion while the inefficiency index reflects the motor performance of a segment in carrying out a locomotor task These indices could provide physical markers for quantifying balance and gait disorders and their progression and thus help in disease monitoring
However 3D motion analysis is costly in both human and technical terms and is restricted to a laboratory environment
At present in France movement analysis laboratories are not widely available for clinical evaluation which limits the screening of balance and gait disorders in the early stages of MS and their follow-up in private practice On the other hand inertial measurement systems are inexpensive easy-to-use tools that could help detect balance and gait disorders at an early stage in MS In fact inertial units comprise at least an accelerometer and a gyroscope which can also be combined with a magnetometer The kinematics of body segments could be used to calculate contribution and inefficiency indexes in an ecological approach geared towards everyday practice thus democratizing and facilitating the monitoring of these disorders
In this study the medical device used is Trigno Avanti Sensor This research evaluates a medical strategy that would enable to validate the transposition of a method for calculating contribution and inefficiency indexes from data obtained by the medical device
The clinical presentation of MS is highly polymorphic Patients may present with motor deficits sensory disorders spasticity gait disorders balance disorders visual disturbances etc The symptoms that have the greatest impact on patients quality of life in the first 5 years following diagnosis are gait and balance disorders However these early disorders are barely visible on clinical examination and are not highlighted by the balance and gait tests frequently used in routine practice These sub-clinical locomotor disorders are also not taken into account by the Expanded Disability Status Scale EDSS However the discomfort reported by patients is objectified using the Multiple Sclerosis Walking Scale-12 MSWS-12 questionnaire
The management of balance and gait disorders is essential to limit deconditioning during exercise and reduce their impact on patients quality of life Detecting these disorders is therefore a key factor in improving our understanding of them and enabling us to provide appropriate rehabilitation
In the early stages gait and balance disorders can be detected by means of three-dimensional movement analysis
Certain parameters such as contribution and inefficiency indexes have proved useful in detecting and quantifying gait and balance disorders in early-stage MS patients These indexes are based on the calculation of linear moments The contribution index reflects the contribution of each body segment to body forward motion while the inefficiency index reflects the motor performance of a segment in carrying out a locomotor task These indices could provide physical markers for quantifying balance and gait disorders and their progression and thus help in disease monitoring
However 3D motion analysis is costly in both human and technical terms and is restricted to a laboratory environment
At present in France movement analysis laboratories are not widely available for clinical evaluation which limits the screening of balance and gait disorders in the early stages of MS and their follow-up in private practice On the other hand inertial measurement systems are inexpensive easy-to-use tools that could help detect balance and gait disorders at an early stage in MS In fact inertial units comprise at least an accelerometer and a gyroscope which can also be combined with a magnetometer The kinematics of body segments could be used to calculate contribution and inefficiency indexes in an ecological approach geared towards everyday practice thus democratizing and facilitating the monitoring of these disorders
In this study the medical device used is Trigno Avanti Sensor This research evaluates a medical strategy that would enable to validate the transposition of a method for calculating contribution and inefficiency indexes from data obtained by the medical device
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None