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Completed

NCT Number: NCT01611597

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

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.

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Key information

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Myologie - GH Pitié Salpétrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Different standardized tasks with an accelerometer device

Other

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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Institut de Myologie, France

Other

Registry information

Acronym: Pre-Acti

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jun 5, 2012
Registry last updated
Apr 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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