Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients
Pre-Acti
1 other identifier
interventional
8
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 30, 2012
CompletedFirst Posted
Study publicly available on registry
June 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedApril 19, 2013
April 1, 2013
1 year
May 30, 2012
April 18, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
Physical activity variables of upper limbs movement in standardized setting
at baseline
Physical activity variables of upper limbs movement in standardized setting
14 days after baseline
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- severe intellectual impairment limiting the comprehension of the demanded tasks
- surgery scheduled within 3 weeks after enrollment
- pregnant or nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut de Myologie - GH Pitié Salpétrière
Paris, 75013, France
Related Publications (1)
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.
PMID: 27271157DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurent Servais, MD, PhD
institut de myologie
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2012
First Posted
June 5, 2012
Study Start
January 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
April 19, 2013
Record last verified: 2013-04