NCT06439823

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
27mo left

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Aug 2022Aug 2028

Study Start

First participant enrolled

August 24, 2022

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

May 28, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

5.9 years

First QC Date

May 28, 2024

Last Update Submit

February 10, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patient with neuromuscular disease or control subjects

EXPERIMENTAL

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®

Interventions

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

Patient with neuromuscular disease or control subjects

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any other previous or present pathology having an impact on current motor or balance function
  • For control subjects, athlete of at least national level.
  • Pregnant or breast-feeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHR citadelle

Liège, Liege, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Neuromuscular Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor Laurent Servais

Study Record Dates

First Submitted

May 28, 2024

First Posted

June 3, 2024

Study Start

August 24, 2022

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

February 12, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations