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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institut de Myologie, France
ClinicalTrials.gov Identifier:
NCT01611597
First received: May 30, 2012
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Neuromuscular Disease
Other: Different standardized tasks with an accelerometer device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients

Resource links provided by NLM:


Further study details as provided by Institut de Myologie, France:

Primary Outcome Measures:
  • Physical activity variables of upper limbs movement at home [ Time Frame: each day for 14 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Physical activity variables of upper limbs movement in standardized setting [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    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.

  • Physical activity variables of upper limbs movement in standardized setting [ Time Frame: 14 days after baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 8
Study Start Date: January 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Names:
    • MyoGrip
    • MyoPinch
    • Moviplate
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

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01611597

Locations
France
Institut de Myologie - GH Pitié Salpétrière
Paris, France, 75013
Sponsors and Collaborators
Institut de Myologie, France
Investigators
Principal Investigator: Laurent Servais, MD, PhD institut de myologie
  More Information

No publications provided

Responsible Party: Institut de Myologie, France
ClinicalTrials.gov Identifier: NCT01611597     History of Changes
Other Study ID Numbers: Pre-Acti
Study First Received: May 30, 2012
Last Updated: April 18, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut de Myologie, France:
accelerometry
neuromuscular disease

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on August 28, 2014