Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06152302
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-10-30
Brief Title:
Test of Aquatic Mobility of SMA Infants
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Analysis of Mobility in the Bath for Infants Affected With Spinal Muscular Atrophy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
BAINSMA
Brief Summary:
Spinal muscular atrophy SMA is a genetic neurodegenerative disease impacting spinal cord motor neurons leading to motor and respiratory issues and ultimately death With emerging therapies a need arises to enhance motor function assessment in severely hypotonic infants SMA type 1 as traditional scales on examination tables lack completeness due to gravitys influence
The study team has developed a bath test to observe infants motor skills in water eliminating gravitys effects This test aims to detect subtle movements using inertial sensors potentially revealing more active motor neurons in aquatic conditions It aids in identifying infants with motor improvement potential even if they show limited mobility outside water and tracks disease progression and therapy responses
Presently pediatric neurologists in France use parent-provided bathing videos for evaluations but these lack standardization and precision The study aims to establish a standardized evaluation protocol with quantifiable data
The studys key objective is to evaluate severely hypotonic SMA infants using inertial sensors including accelerometers gyrometers and magnetometers The study will conduct dry and water assessments using a specially designed bathtub This methods goal is to quantify water-based movements accurately
Simultaneously the study seeks to establish semi-quantitative evaluation criteria to create a clinical assessment scale for infant motor function in bathtubs This scale will aid doctors in therapeutic decisions The study will not influence the treatment or therapeutic decisions made for the children being tested
Collected data from dry and water conditions will be statistically analyzed and compared to reference motor assessment scales eg CHOP INTEND and HINE and electromyography CMAP-EMG results commonly used in diagnosis and monitoring Blurred video recordings will assist in protocol monitoring and sensor data analysis
The study team has developed a bath test to observe infants motor skills in water eliminating gravitys effects This test aims to detect subtle movements using inertial sensors potentially revealing more active motor neurons in aquatic conditions It aids in identifying infants with motor improvement potential even if they show limited mobility outside water and tracks disease progression and therapy responses
Presently pediatric neurologists in France use parent-provided bathing videos for evaluations but these lack standardization and precision The study aims to establish a standardized evaluation protocol with quantifiable data
The studys key objective is to evaluate severely hypotonic SMA infants using inertial sensors including accelerometers gyrometers and magnetometers The study will conduct dry and water assessments using a specially designed bathtub This methods goal is to quantify water-based movements accurately
Simultaneously the study seeks to establish semi-quantitative evaluation criteria to create a clinical assessment scale for infant motor function in bathtubs This scale will aid doctors in therapeutic decisions The study will not influence the treatment or therapeutic decisions made for the children being tested
Collected data from dry and water conditions will be statistically analyzed and compared to reference motor assessment scales eg CHOP INTEND and HINE and electromyography CMAP-EMG results commonly used in diagnosis and monitoring Blurred video recordings will assist in protocol monitoring and sensor data analysis
Detailed Description:
This is a multicenter research project coordinated by the Child Neuromuscular Unit at Raymond Poincaré Hospital Additionally two other pediatric neurology departments part of the national neuromuscular network FILNEMUS httpswwwfilnemusfr will participate in the study Necker Childrens Hospital and Armand Trousseau Hospital
The studys population will include all infants diagnosed with spinal muscular atrophy SMA specifically SMA type 1 who have onset before 6 months of age and have been evaluated by the French Therapeutic Commission Participation in the study will be contingent on parental or guardian consent during follow-up visits
Spinal muscular atrophy is a genetic neurodegenerative condition that affects spinal motor neurons causing motor and respiratory paralysis and ultimately leading to death As groundbreaking therapies emerge theres an increasing need to refine the methods used to assess motor function especially in infants with severe hypotonia due to SMA type 1 Traditional reference scales used on examination tables are limited in their accuracy because of gravitational effects Consequently theres growing interest in evaluating these childrens motor skills in water to detect movements unburdened by gravity Pediatric neurologists in France SFNP have already acknowledged the potential value of parental video recordings during infant baths However the lack of standardization in recording conditions coupled with the subjective nature of video interpretations underscores the necessity for a more standardized and quantifiable approach Herein lies the application of our proposed evaluation utilizing inertial sensors
Utilizing inertial sensors to detect subtle movements can highlight still-active yet minimally functional motor neurons Such detection can be pivotal in identifying children who despite severe motor skill limitations in traditional settings still possess developmental potential Our study seeks to leverage these sensors-equipped with accelerometers gyroscopes and magnetometers-to carry out evaluations both in dry conditions and water conditions using a specially designed secure bathtub
The study aims to validate the relevance of quantifying movements in aquatic settings using inertial sensors in order to assess motor function in very hypotonic children Additionally this study will contribute to the development of a semi-quantitative clinical evaluation grid for assessing infant motor function in water assisting physicians in making more informed therapeutic decisions for these children Data obtained from measurements with inertial sensors in both environments dry and water will be correlated with scores from validated motor scales CHOP INTEND HINE-2 and the clinical characteristics of the patients eg age disease duration SMA type SMN2 copies severity CMAPs EMG Anamnestic clinical and inertial data will be anonymized
The equipment required for the protocol comprises an examination table a bath a support for the head and back httpswwwneutfrfr 8 CE-validated Xsens DOT inertial sensors a dedicated research smartphone with the Xsens DOT application for data export a camera mounted on a pole connected to an acquisition tablet The study will utilize a fixed PC computer with secure access located in a dedicated research room within the Pediatric Neurology and Intensive Care Unit at Raymond Poincaré Hospital
Video recording throughout the evaluation will be carried out from an overhead perspective capturing all four limbs in the frame and ensuring that the child occupies approximately 50 of the cameras field of vision To comply with privacy regulations MR-001 the videos will obscure any identifying features such as faces or other body parts of the patients These videos will serve as a reference for controlling and validating the data collected by the inertial sensors
The studys outputs will include inertial data from 8 inertial sensors placed on the arms 2 forearms 2 thighs 2 and legs 2 Our motor evaluation process is split into two distinct phases totaling 6 minutes a dry phase affected by gravity and a water phase where gravitys effects are mitigated The surrounding time is allocated for essential tasks such as positioning the child fitting the sensors and ensuring the infants comfort throughout the process Notably our study doesnt seek to alter the standard care or therapeutic decisions for the participants
The measurements will follow a specific process
Dry phase This involves evaluating limb movements under the constraints of gravity The child is placed in a supine position on the examination table set horizontally 0 To minimize signal artifacts physical contact with the child should be avoided If the childs behavior is unfavorable eg crying the measurement is paused and resumed once the childs condition stabilizes Spontaneous or induced movements are collected for 2 minutes with the entire duration filmed for monitoring the inertial sensor data
Intermediate phase The diaper is removed and the child is positioned in a support inclined at 20 then transferred to the bathtub This transition should be made in a reassuring manner for the child respecting their pace of adaptation
Water phase This phase involves evaluating limb movements without gravity constraints Spontaneous or induced movements are collected for 4 minutes with the entire duration filmed for monitoring the inertial sensor data Measurements may also be paused and resumed based on the childs behavior
The processes of sensor installation and sensor removal are accompanied by sensorimotor stimulation
The studys population will include all infants diagnosed with spinal muscular atrophy SMA specifically SMA type 1 who have onset before 6 months of age and have been evaluated by the French Therapeutic Commission Participation in the study will be contingent on parental or guardian consent during follow-up visits
Spinal muscular atrophy is a genetic neurodegenerative condition that affects spinal motor neurons causing motor and respiratory paralysis and ultimately leading to death As groundbreaking therapies emerge theres an increasing need to refine the methods used to assess motor function especially in infants with severe hypotonia due to SMA type 1 Traditional reference scales used on examination tables are limited in their accuracy because of gravitational effects Consequently theres growing interest in evaluating these childrens motor skills in water to detect movements unburdened by gravity Pediatric neurologists in France SFNP have already acknowledged the potential value of parental video recordings during infant baths However the lack of standardization in recording conditions coupled with the subjective nature of video interpretations underscores the necessity for a more standardized and quantifiable approach Herein lies the application of our proposed evaluation utilizing inertial sensors
Utilizing inertial sensors to detect subtle movements can highlight still-active yet minimally functional motor neurons Such detection can be pivotal in identifying children who despite severe motor skill limitations in traditional settings still possess developmental potential Our study seeks to leverage these sensors-equipped with accelerometers gyroscopes and magnetometers-to carry out evaluations both in dry conditions and water conditions using a specially designed secure bathtub
The study aims to validate the relevance of quantifying movements in aquatic settings using inertial sensors in order to assess motor function in very hypotonic children Additionally this study will contribute to the development of a semi-quantitative clinical evaluation grid for assessing infant motor function in water assisting physicians in making more informed therapeutic decisions for these children Data obtained from measurements with inertial sensors in both environments dry and water will be correlated with scores from validated motor scales CHOP INTEND HINE-2 and the clinical characteristics of the patients eg age disease duration SMA type SMN2 copies severity CMAPs EMG Anamnestic clinical and inertial data will be anonymized
The equipment required for the protocol comprises an examination table a bath a support for the head and back httpswwwneutfrfr 8 CE-validated Xsens DOT inertial sensors a dedicated research smartphone with the Xsens DOT application for data export a camera mounted on a pole connected to an acquisition tablet The study will utilize a fixed PC computer with secure access located in a dedicated research room within the Pediatric Neurology and Intensive Care Unit at Raymond Poincaré Hospital
Video recording throughout the evaluation will be carried out from an overhead perspective capturing all four limbs in the frame and ensuring that the child occupies approximately 50 of the cameras field of vision To comply with privacy regulations MR-001 the videos will obscure any identifying features such as faces or other body parts of the patients These videos will serve as a reference for controlling and validating the data collected by the inertial sensors
The studys outputs will include inertial data from 8 inertial sensors placed on the arms 2 forearms 2 thighs 2 and legs 2 Our motor evaluation process is split into two distinct phases totaling 6 minutes a dry phase affected by gravity and a water phase where gravitys effects are mitigated The surrounding time is allocated for essential tasks such as positioning the child fitting the sensors and ensuring the infants comfort throughout the process Notably our study doesnt seek to alter the standard care or therapeutic decisions for the participants
The measurements will follow a specific process
Dry phase This involves evaluating limb movements under the constraints of gravity The child is placed in a supine position on the examination table set horizontally 0 To minimize signal artifacts physical contact with the child should be avoided If the childs behavior is unfavorable eg crying the measurement is paused and resumed once the childs condition stabilizes Spontaneous or induced movements are collected for 2 minutes with the entire duration filmed for monitoring the inertial sensor data
Intermediate phase The diaper is removed and the child is positioned in a support inclined at 20 then transferred to the bathtub This transition should be made in a reassuring manner for the child respecting their pace of adaptation
Water phase This phase involves evaluating limb movements without gravity constraints Spontaneous or induced movements are collected for 4 minutes with the entire duration filmed for monitoring the inertial sensor data Measurements may also be paused and resumed based on the childs behavior
The processes of sensor installation and sensor removal are accompanied by sensorimotor stimulation
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A01419-34 | REGISTRY | IDRCB | None |