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

Neuromuscular Disease Clinical Trial

— Pre-Acti  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611597
• Other study ID #: Pre-Acti
• Status: Completed
• Phase: N/A
• First received: May 30, 2012
• Last updated: April 18, 2013
• Start date: January 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: Institut de Myologie, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 80 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Neuromuscular Disease
• Neuromuscular Diseases

Intervention

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.

Locations

Country	Name	City	State
France	Institut de Myologie - GH Pitié Salpétrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Myologie, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No