Neuromuscular DiseasesNCT06439823
Controlled Study of Upper and Lower Limb Movements in Patients Patients with Pathologies That Have an Impact on Ambulation or Motor Function
A study testing ActiMyo®/Syde® in people with Neuromuscular Diseases, run by Laurent Servais at 1 site in Belgium.
Trial summary
The main aim of the study is to validate the algorithms developed to analyze the signals from the various sensors contained in the magneto-inertial control units and reconstruct upper and lower limb movements under different normal and pathological conditions. Read more about this study
- Who is it for?
- Ages 2 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Diseases
- What is being tested?
- ActiMyo®/Syde®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Aug 2022to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 2 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subjects over 2 years old
- Male or female
- Control subjects with no pathologies that have an impact on ambulation or motor function.
- Signed informed consent and, in the case of minors, informed consent signed by the person with parental authority/guardian
Who cannot join
- Any other previous or present pathology having an impact on current motor or balance function
- Recent surgery or trauma to upper or lower limbs, or major surgery or trauma within 6 months of inclusion.
- For control subjects, athlete of at least national level.
- Pregnant or breast-feeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
CHR citadelle
Liège, Liege, 4000
Laurie Medard, 003243218222, laurie.medard@citadelle.be
About this study
Official title: Controlled Study of Upper and Lower Limb Movements in Patients Patients with Pathologies That Have an Impact on Ambulation or Motor Function to Validate Signal Analysis Algorithms for Wearable Devices Using Magneto-inertial Technology
The main aim of the study is to validate the algorithms developed to analyze the signals from the various sensors contained in the magneto-inertial control units and reconstruct upper and lower limb movements under different normal and pathological conditions.
- Conditions
- Neuromuscular Diseases
- Being tested
- ActiMyo®/Syde®
- Medical subject headings
- Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiMyo®/Syde®Device
Subjects will be equipped with magneto-inertial sensors (ActiMyo®/Syde®) and passive reflective markers belonging to the MoCap® motion capture system.
| Study group | Role | What they receive |
|---|---|---|
| Patient with neuromuscular disease or control subjects | Experimental | Patients and controls will be examined by a neuropediatric or neurologist. they will perform upper and lower limb assessments in a walking laboratory. this study comprises a single session per patient/control subject. Receives: Device: ActiMyo®/Syde® |
What is being measured
The primary outcome is the main question the study is designed to answer.
step length and distance
Validate the algorithms developed to analyze the signals from the various sensors contained in magneto-inertial control units and reconstruct upper and lower limb movements.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start24 Aug 2022
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular DiseasesStudies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laurent Servais
- Sponsor type
- University, hospital or other
- Collaborators
- SYSNAV
- Responsible party
- Sponsor-investigator, Laurent Servais, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06439823
- Sponsor's protocol ID
- MoCAP
- Status last verified
- Feb 2025
- First submitted
- 28 May 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Study of Upper and Lower Limb Movements in Patients Patients with Pathologies That Have an Impact on Ambulation or Motor Function to Validate Signal Analysis Algorithms for Wearable Devices Using Magneto-inertial Technology
- ClinicalTrials.gov ID
- NCT06439823
- Acronym / sponsor ID
- MoCAP
- Conditions
- Neuromuscular Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Laurent ServaisUniversity, hospital or other
- Collaborators
- SYSNAV
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 3 Jun 2024 (actual)
- 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.
The main aim of the study is to validate the algorithms developed to analyze the signals from the various sensors contained in the magneto-inertial control units and reconstruct upper and lower limb movements under different normal and pathological conditions.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with neuromuscular disease or control subjects | Experimental | Device: ActiMyo®/Syde®Patients and controls will be examined by a neuropediatric or neurologist. they will perform upper and lower limb assessments in a walking laboratory. this study comprises a single session per patient/control subject. |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects over 2 years old
- Male or female
- Control subjects with no pathologies that have an impact on ambulation or motor function.
- Signed informed consent and, in the case of minors, informed consent signed by the person with parental authority/guardian
Key exclusion criteria (4 listed)
- Any other previous or present pathology having an impact on current motor or balance function
- Recent surgery or trauma to upper or lower limbs, or major surgery or trauma within 6 months of inclusion.
- For control subjects, athlete of at least national level.
- Pregnant or breast-feeding 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 |
|---|---|---|
| ActiMyo®/Syde®Subjects will be equipped with magneto-inertial sensors (ActiMyo®/Syde®) and passive reflective markers belonging to the MoCap® motion capture system. | Device | Patient with neuromuscular disease or control subjects |
Primary outcome
step length and distance
Time frame: 36 months
Validate the algorithms developed to analyze the signals from the various sensors contained in magneto-inertial control units and reconstruct upper and lower limb movements.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiMyo®/Syde® in people with Neuromuscular Diseases, run by Laurent Servais at 1 site in Belgium.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Feb 2025. 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 Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurie Medard (003243218222, laurie.medard@citadelle.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
step length and distance (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Feb 2025.