Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients (Pre-Acti)

Validation of a measure specifically suitable to evaluate the residual function of upper limbs of non-ambulant neuromuscular patients, especially with Duchenne muscular dystrophy and spinal muscular atrophy.

This approach is of fundamental importance for clinical monitoring and preparing the future therapeutic trials.

Study Overview

• Status: Completed
• Conditions: Neuromuscular Disease
• Intervention / Treatment: Other: Different standardized tasks with an accelerometer device

Detailed Description

The main objective is the continuous measurement of muscle activity in a standardized setting and in the non ambulatory patient's natural environment. This measure uses an innovative technology based on accelerometer and magneto-inertial sensors. The system is intended to measure the physical activity of patients from the extraction of data recorded by the sensors in the three space axes.

The non ambulatory patients will be included and evaluated at baseline and 14 days later. The patients wear the accelerometer device during some standard evaluations and also at home continuously for 14 days.

With this protocol the investigators want to try to find the best variable that characterizes the movement of the upper limbs of non-ambulant neuromuscular patients.

The aim of Pre-Acti is to propose a primary outcome measure that may be used in clinical monitoring of patients.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Institut de Myologie - GH Pitié Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 80 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• age over 10 years
• neuromuscular disease documented by genetic testing or by muscle biopsy
• not able to walk 10 meters without support
• capable of sitting upright in a wheelchair for at least 3 hours
• subject affiliated to a social security system
• subject who signed an informed consent

Exclusion Criteria:

• severe intellectual impairment limiting the comprehension of the demanded tasks
• acute neurologic, inflammatory, infectious, endocrine, orthopedic disease in the month preceding the inclusion
• surgery scheduled within 3 weeks after enrollment
• surgery at upper limbs in the three months preceding the inclusion
• pregnant or nursing women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity variables of upper limbs movement at home	A watch containing and inertial system will be worn by non-ambulant patients with neuromuscular diseases at home for 14 days. Physical activity variables will be deduced from these measurements.	each day for 14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity variables of upper limbs movement in standardized setting	A watch containing and inertial system will be worn by non-ambulant patients with neuromuscular diseases during standardized tasks. Physical activity variables will be deduced from these measurements.	at baseline
Physical activity variables of upper limbs movement in standardized setting	A watch containing and inertial system will be worn by non-ambulant patients with neuromuscular diseases during standardized tasks. Physical activity variables will be deduced from these measurements.	14 days after baseline

Collaborators and Investigators

• Sponsor: Institut de Myologie, France

Publications and helpful links

General Publications

• Le Moing AG, Seferian AM, Moraux A, Annoussamy M, Dorveaux E, Gasnier E, Hogrel JY, Voit T, Vissiere D, Servais L. A Movement Monitor Based on Magneto-Inertial Sensors for Non-Ambulant Patients with Duchenne Muscular Dystrophy: A Pilot Study in Controlled Environment. PLoS One. 2016 Jun 7;11(6):e0156696. doi: 10.1371/journal.pone.0156696. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: May 30, 2012
• First Submitted That Met QC Criteria: June 1, 2012
• First Posted (ESTIMATE): June 5, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 19, 2013
• Last Update Submitted That Met QC Criteria: April 18, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: neuromuscular disease; accelerometry
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases
• Other Study ID Numbers: Pre-Acti