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

Not Applicable

Recruiting

• Conditions: Neuromuscular Diseases
• Interventions: Device: ActiMyo®/Syde®

• Registration Number: NCT06439823
• Lead Sponsor: Laurent Servais

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-24
• Study First Submitted: 2024-05-28
• Study First Submitted QC: 2024-05-31
• Study First Posted: 2024-06-03
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-12
• Primary Completion: 2028-08
• Study Completion: 2028-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with neuromuscular disease or control subjects	ActiMyo®/Syde®	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.

Primary Outcome Measures

Name	Time	Method
step length and distance	36 months	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.

Trial Locations

Locations (1)

CHR citadelle; 🇧🇪 Liège, Liege, Belgium