Controlled Study of Upper and Lower Limb Movements in Patients With Neurological Pathologies

Neuromuscular Diseases Clinical Trial

Official title:

Controlled Study of Upper and Lower Limb Movements in Patients With Neurological Pathologies to Validate Signal Analysis Algorithms for Wearable Devices Using Magneto-inertial Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06439823
• Other study ID #: MoCAP
• Status: Recruiting
• Phase: N/A
• Start date: August 24, 2022
• Est. completion date: August 2028

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Régional de la Citadelle
• Contact: Laurie Medard
• Phone: 003243218222
• Email: laurie.medard[@]citadelle.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main aim of the study is to validate the algorithms developed to analyze the signals from the various sensors contained in the magneto-inertial control units and reconstruct upper and lower limb movements under different normal and pathological conditions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2028
• Est. primary completion date: August 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

• Subjects over 2 years old

• Male or female

• Control subjects with no neurological pathology or gait or osteoarticular disorders OR Patients with a neurological condition affecting movement and whose diagnosis is confirmed by a neurologist.

• Signed informed consent and, in the case of minors, informed consent signed by the person with parental authority/guardian

Exclusion Criteria:

• Any other previous or present pathology having an impact on current motor or balance function

• Recent surgery or trauma to upper or lower limbs, or major surgery or trauma within 6 months of inclusion.

• For control subjects, athlete of at least national level.

• Pregnant or breast-feeding women

Related Conditions & MeSH terms

• Neuromuscular Diseases

Intervention

Device:
• ActiMyo®/Syde®
Subjects will be equipped with magneto-inertial sensors (ActiMyo®/Syde®) and passive reflective markers belonging to the MoCap® motion capture system.

Locations

Country	Name	City	State
Belgium	CHR citadelle	Liège	Liege

Sponsors (2)

Lead Sponsor	Collaborator
Laurent Servais	SYSNAV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	step length and distance	Validate the algorithms developed to analyze the signals from the various sensors contained in magneto-inertial control units and reconstruct upper and lower limb movements.	36 months