Controlled Study of Upper and Lower Limb Movements in Patients Patients with Pathologies That Have an Impact on Ambulation or Motor Function

Controlled Study of Upper and Lower Limb Movements in Patients Patients with Pathologies That Have an Impact on Ambulation or Motor Function to Validate Signal Analysis Algorithms for Wearable Devices Using Magneto-inertial Technology

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.

Study Overview

• Status: Recruiting
• Conditions: Neuromuscular Diseases
• Intervention / Treatment: Device: ActiMyo®/Syde®

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurie Medard; Phone Number: 003243218222; Email: laurie.medard@citadelle.be

Study Locations

• Belgium
  • Liege
    • Liège, Liege, Belgium, 4000
      • Recruiting
      • CHR Citadelle
      • Contact: Laurie Medard; Phone Number: 003243218222; Email: laurie.medard@citadelle.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Subjects over 2 years old
• Male or female
• Control subjects with no pathologies that have an impact on ambulation or motor function.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient with neuromuscular disease or control subjects; Patients and controls will be examined by a neuropediatric or neurologist. they will perform upper and lower limb assessments in a walking laboratory. this study comprises a single session per patient/control subject.	Device: ActiMyo®/Syde®; Subjects will be equipped with magneto-inertial sensors (ActiMyo®/Syde®) and passive reflective markers belonging to the MoCap® motion capture system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Laurent Servais
• Collaborators: SYSNAV

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2022
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: May 28, 2024
• First Submitted That Met QC Criteria: May 31, 2024
• First Posted (Actual): June 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 10, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: MoCAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No