NCT01611597

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Institut de Myologie, France · Academic / Other
• Sex: All
• Age: 10 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuromuscular Disease

Interventions

Type	Name	Description
OTHER	Different standardized tasks with an accelerometer device	Patients will perform tests like hand grip (MyoGrip), pinch (MyoPinch), Moviplate, box and block test of hand function, Minnesota Manual Dexterity Test. The tests will be performed with the accelerometer device worn on the wrist.

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-06-05
• Last updated: 2013-04-19

Locations

1 site across 1 country: France