Clinical trial NCT01611597: Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients
Official title: Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuromuscular Disease
Keywords: accelerometry
neuromuscular disease
Lead sponsor: Institut de Myologie, France
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 8
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physical activity variables of upper limbs movement at home
timeFrame: each day for 14 days
Secondary outcomes:
measure: Physical activity variables of upper limbs movement in standardized setting
timeFrame: at baseline
measure: Physical activity variables of upper limbs movement in standardized setting
timeFrame: 14 days after baseline
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut de Myologie - GH Pitié Salpétrière
Study officials:
affiliation: institut de myologie
name: Laurent Servais, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.