Neuromuscular DiseasePre-ActiNCT01611597
Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients
A study testing Different standardized tasks with an accelerometer device in people with Neuromuscular Disease, run by Institut de Myologie, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Neuromuscular Disease
- What is being tested?
- Different standardized tasks with an accelerometer device
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Neuromuscular Disease
- Being tested
- Different standardized tasks with an accelerometer device
- Keywords
- accelerometry, neuromuscular disease
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Different standardized tasks with an accelerometer deviceOther
Also called MyoGrip, MyoPinch, Moviplate
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: each day for 14 days
Secondary outcomes (2)
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.
Measured: at baseline
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.
Measured: 14 days after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neuromuscular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Myologie, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent Servais, MD, PhD, Principal investigator, institut de myologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01611597
- Sponsor's protocol ID
- Pre-Acti
- Acronym
- Pre-Acti
- Status last verified
- Apr 2013
- First submitted
- 30 May 2012
- Last updated
- 19 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27271157
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Measurement of the Activity for Clinical Evaluation at Home, for Non-ambulant Neuromuscular Patients
- ClinicalTrials.gov ID
- NCT01611597
- Acronym / sponsor ID
- Pre-Acti / Pre-Acti
- Conditions
- Neuromuscular Disease
- Keywords
- accelerometry, neuromuscular disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Institut de Myologie, FranceUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Different standardized tasks with an accelerometer deviceAlso: MyoGrip, MyoPinch, MoviplatePatients 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 | – |
Primary outcome
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.
2 secondary outcomes
Physical activity variables of upper limbs movement in standardized setting
Time frame: at baseline
Physical activity variables of upper limbs movement in standardized setting
Time frame: 14 days after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2013.
- Derived from this study: PubMed 27271157Le 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Servais, MD, PhD principal investigator
institut de myologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Different standardized tasks with an accelerometer device in people with Neuromuscular Disease, run by Institut de Myologie, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity variables of upper limbs movement at home (time frame: each day for 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01611597, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2013; AzTrials last refreshed its copy on 7 Nov 2026.