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Holter of Movement in Patients with SMA Undergoing Treatment.

NCT04888702 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-02-12

No results posted yet for this study

Summary

Acti-SMA is a multi-centric academic study. It aims to monitor the progress of patients with spinal muscular atrophy under treatment with Spinraza° or risdiplam. First, we want to quantify improvement of both ambulant and non-ambulant patients under treatment. A secondary objective would also be to identify suitable accelerometric measurements that are sensitive to change but also well correlated to other clinical scores.

Conditions

Interventions

DEVICE

Actimyo

Actimyo° is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.

Sponsors & Collaborators

  • SYSNAV

    collaborator INDUSTRY

  • Erasme University Hospital

    collaborator OTHER

  • Queen Fabiola Children's University Hospital

    collaborator OTHER

  • Centre Hospitalier Régional de la Citadelle

    collaborator OTHER

  • Centre Hospitalier Universitaire de Liege

    lead OTHER

Principal Investigators

  • Margaux Poleur · CHR Citadelle-CHU liège

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-08
Primary Completion
2025-01-30
Completion
2025-05-30

Countries

  • Belgium
  • Romania

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04888702 on ClinicalTrials.gov