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

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ClinicalTrials.gov Identifier: NCT01611597
Recruitment Status : Completed
First Posted : June 5, 2012
Last Update Posted : April 19, 2013
Sponsor:
Information provided by (Responsible Party):
Institut de Myologie, France

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.


Condition or disease Intervention/treatment Phase
Neuromuscular Disease Other: Different standardized tasks with an accelerometer device Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients
Study Start Date : January 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. Physical activity variables of upper limbs movement at home [ Time Frame: each day for 14 days ]
    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 :
  1. Physical activity variables of upper limbs movement in standardized setting [ Time Frame: at baseline ]
    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.

  2. Physical activity variables of upper limbs movement in standardized setting [ Time Frame: 14 days after baseline ]
    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.



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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Institut de Myologie, France
ClinicalTrials.gov Identifier: NCT01611597     History of Changes
Other Study ID Numbers: Pre-Acti
First Posted: June 5, 2012    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013

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

Additional relevant MeSH terms:
Neuromuscular Diseases
Nervous System Diseases