Multiple SclerosisNCT04888689
Holter of Movement in Patients with Multiple Sclerosis in Controlled Environment.
A study testing Actimyo° and IMU in people with Multiple Sclerosis, run by Laurent Servais at 1 site in Belgium.
Trial summary
ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. We plan to include a group of approximately 20 patients with MS. This study include a unique evaluation in the laboratory of analysis of human movement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Actimyo° and IMU
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteBelgium
- Study dates
- 4 Feb 2021to 30 Sep 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed MS diagnosis,
- Over 18 years old,
- Ambulant patients,
- Signed informed consent,
- No clinical and / or radiological relapse within 3 months.
Who cannot join
- Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
- Any other previous or present pathology having an impact on motor function.
- Recent surgery or trauma (less than 6 months) in the upper or lower limbs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Holter of Movement in Patients with Multiple Sclerosis. Acti-SEP Study: Controlled Environment.
ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. We plan to include a group of approximately 20 patients with MS.
This study include a unique evaluation in the laboratory of analysis of human movement. A set of tasks will be performed by patients wearing of two magneto-inertial sensors.
- Conditions
- Multiple Sclerosis
- Being tested
- Actimyo°, IMU
- Keywords
- Actimyo, Accelerometry, Motion laboratory
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Actimyo°Device
Actimyo° is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
IMUDevice
IMU is a portable system of miniaturized inertial sensors for objective, instrumental, ambulatory, and validated analysis of normal and pathological human gait. Each miniaturized inertial sensor (2 cm × 0.7 cm × 0.5 cm) includes a triaxial accelerometer and a triaxial gyroscope.
These four inertial sensors are connected to a box by wires and are numbered 1 to 4. They must be attached - using adhesive tapes - on the participant's shoes.
| Study group | Role | What they receive |
|---|---|---|
| MS patients | Experimental | Ambulant patients with multiple sclerosis Receives: Device: Actimyo°; Device: IMU |
What is being measured
The primary outcome is the main question the study is designed to answer.
95th centile of stride velocity
95th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
Measured: One day
50th centile of stride velocity
50th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
Measured: One day
95th centile of stride length
95th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).
Measured: One day
50th centile of stride length
50th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).
Measured: One day
Stance phase time
Stance time over full stride time for each foot obtained with magneto-inertial sensors and a motion capture device (percentage).
Measured: One day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start4 Feb 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all patients undergo clinical evaluation while wearing Actimyo device to assess their gait.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laurent Servais
- Sponsor type
- University, hospital or other
- Collaborators
- SYSNAV, Centre Hospitalier Régional de la Citadelle
- Responsible party
- Sponsor-investigator, Laurent Servais, Centre Hospitalier Universitaire de Liege
- Investigators
- Margaux Poleur, MD, Principal investigator, CHR Citadelle-CHU liège
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888689
- Sponsor's protocol ID
- ActiSEP. Part 1.
- Status last verified
- Feb 2025
- First submitted
- 11 Mar 2021
- 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
- Holter of Movement in Patients with Multiple Sclerosis. Acti-SEP Study: Controlled Environment.
- ClinicalTrials.gov ID
- NCT04888689
- Acronym / sponsor ID
- ActiSEP. Part 1.
- Conditions
- Multiple Sclerosis
- Keywords
- Actimyo, Accelerometry, Motion laboratory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Laurent ServaisUniversity, hospital or other
- Collaborators
- SYSNAV, Centre Hospitalier Régional de la Citadelle
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 17 May 2021 (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.
ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. We plan to include a group of approximately 20 patients with MS.
This study include a unique evaluation in the laboratory of analysis of human movement. A set of tasks will be performed by patients wearing of two magneto-inertial sensors.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all patients undergo clinical evaluation while wearing Actimyo device to assess their gait.
| Arm | Type | Receives |
|---|---|---|
| MS patients | Experimental | Device: Actimyo°, Device: IMUAmbulant patients with multiple sclerosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed MS diagnosis,
- Over 18 years old,
- Ambulant patients,
- Signed informed consent,
- No clinical and / or radiological relapse within 3 months.
Key exclusion criteria (3 listed)
- Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
- Any other previous or present pathology having an impact on motor function.
- Recent surgery or trauma (less than 6 months) in the upper or lower limbs
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°Actimyo° is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle. | Device | MS patients |
| IMUIMU is a portable system of miniaturized inertial sensors for objective, instrumental, ambulatory, and validated analysis of normal and pathological human gait. Each miniaturized inertial sensor (2 cm × 0.7 cm × 0.5 cm) includes a triaxial accelerometer and a triaxial gyroscope. These four inertial sensors are connected to a box by wires and are numbered 1 to 4. They must be attached - using adhesive tapes - on the participant's shoes. | Device | MS patients |
Primary outcome
95th centile of stride velocity
Time frame: One day
95th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
50th centile of stride velocity
Time frame: One day
50th centile of stride velocity obtained with magneto-inertial sensors and a motion capture device (meter/second).
95th centile of stride length
Time frame: One day
95th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).
50th centile of stride length
Time frame: One day
50th centile of stride length obtained with magneto-inertial sensors and a motion capture device (meter).
Stance phase time
Time frame: One day
Stance time over full stride time for each foot obtained with magneto-inertial sensors and a motion capture device (percentage).
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 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. This study is not recruiting at the moment.
Margaux Poleur, MD principal investigator
CHR Citadelle-CHU liège
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° and IMU in people with Multiple Sclerosis, 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 5 inclusion and 3 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 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?
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?
95th centile of stride velocity (time frame: One day). The study lists 5 primary outcomes in all. 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.