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

NCT ID: NCT01611597

Last Updated: 2013-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-01-31

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.

Conditions

Neuromuscular Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

MyoGrip; MyoPinch; Moviplate

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut de Myologie, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Servais, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

institut de myologie

Locations

Institut de Myologie - GH Pitié Salpétrière

Paris, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 27271157 (View on PubMed)

Other Identifiers

Pre-Acti

Identifier Type: -

Identifier Source: org_study_id