StrokeMASEA 2NCT02598154
Metrological Characteristics of the Inertial Unit "FOX HiKoB©" in Comparison With the Reference System for the Adaptive Trigger System "Functional Electrical Stimulation" of Foot Elevators in Hemiplegic Post-stroke Patients
An observational study of Stroke, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The main objective of this study is to evaluate the metrological characteristics of the data processing algorithms from inertial sensors (FOX © HiKoB) for the reconstruction of movement relative to the reference system (VICON) for measurement of dorsiflexion at the beginning of a step and in the middle of the… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Stroke
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 20 May 2016to 30 Jun 2017
- Phase
- Observational
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients whose age is between 20 and 75 years and who experienced a supra-tentorial ischemic or hemorrhagic stroke. The study covers inpatients or patients consultating in the neurological rehabilitation service (NHS) at the Grau du Roi Medical Center, Nîmes University Hospital.
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Stroke, ischemic or hemorrhagic, supra-tentorial, regardless of the post-stroke period
- The patient can walk 10m without human help, with or without a cane and has a foot elevator deficit requiring the use of technical assistance or causing a walking defect
Who cannot join
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient or his/her representative refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant or breastfeeding
- The patient has cognitive impairment
- Presence of permanent plantar flexion of the ankle joint with ankle dorsiflexion, knee straight, lower than 0°.
- Uncontrolled epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Metrological Characteristics of the Inertial Unit FOX HiKoB© in Comparison With the Reference System for the Adaptive Trigger System "Functional Electrical Stimulation" of Foot Elevators in Hemiplegic Post-stroke Patients
The main objective of this study is to evaluate the metrological characteristics of the data processing algorithms from inertial sensors (FOX © HiKoB) for the reconstruction of movement relative to the reference system (VICON) for measurement of dorsiflexion at the beginning of a step and in the middle of the oscillating phase.
Read the detailed description
The secondary objectives of this study are:
- / - to assess the metrological characteristics of the data from inertial sensors (FOX © HiKoB) for the reconstruction of the movement in comparison with reference systems (GaitRite or Zebris systems, VICON) in terms of:
- Ability to determine the walking speed, stride length, the acceleration of plantar flexion at the beginning of the weight-bearing phase B. Ability to objectify performance reduction during a 6 minute test. C. Ability to identify different types of movement: simple walking, turn, obstacle clearance, staircase.
- / - to analyze the EMG signal upon voluntary dorsiflexion of the foot of the paretic side from a sitting position before and after a fatigue test (objective D)
- Conditions
- Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study population | The study population consists of patients whose age is between 20 and 75 years and who experienced a supra-tentorial ischemic or hemorrhagic stroke. The study covers inpatients or patients consultating in the neurological rehabilitation service (NHS) at the Grau du Roi Medical Center, Nîmes University Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dorsiflexion (°) at the beginning of a step
Measured: Day 0
Dorsiflexion (°) in the middle of the oscillating phase
Measured: Day 0
Secondary outcomes (7)
Walking speed
Measured: Day 0
Stride length
Measured: Day 0
Maximal angular speed at the ankle between the moment when the heel touches the ground and the moment where the foot is flat (°/s)
Measured: Day 0
6 minute walking test: average dorsiflexion ankle measured between 15 seconds and 30 seconds
Measured: Day 0
6 minute walking test: average dorsiflexion ankle measured between 30 seconds and 5 min 5 min 45 seconds
Measured: Day 0
Detection of obstables: yes/no
Measured: Day 0
EMG signal (%) during voluntary dorsiflexion of the foot of the paretic side in a sitting position before and after fatigue test
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2015 (estimated)
- Study start20 May 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
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 StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme Froger, MD, Principal investigator, Centre Hospitalier Universitaire de NīmesCristine Azevedo Coste, Study director, DEMAR INRIA / LIRMM, 161 rue Ada, 30392 Montpellier Cedex 5
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02598154
- Sponsor's protocol ID
- LOCAL/2015/JF-01
- Other IDs
- 2015-A00572-47
- Acronym
- MASEA 2
- Status last verified
- Aug 2017
- First submitted
- 4 Nov 2015
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Sijobert B, Feuvrier F, Froger J, Guiraud D, Coste CA. A sensor fusion approach for inertial sensors based 3D kinematics and pathological gait assessments: toward an adaptive control of stimulation in post-stroke subjects. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:3497-3500. doi: 10.1109/EMBC.2018.8512985.
PubMed 30441133
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Metrological Characteristics of the Inertial Unit FOX HiKoB© in Comparison With the Reference System for the Adaptive Trigger System "Functional Electrical Stimulation" of Foot Elevators in Hemiplegic Post-stroke Patients
- ClinicalTrials.gov ID
- NCT02598154
- Acronym / sponsor ID
- MASEA 2 / LOCAL/2015/JF-01
- Conditions
- Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 20 May 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 5 Nov 2015 (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.
The main objective of this study is to evaluate the metrological characteristics of the data processing algorithms from inertial sensors (FOX © HiKoB) for the reconstruction of movement relative to the reference system (VICON) for measurement of dorsiflexion at the beginning of a step and in the middle of the oscillating phase.
Detailed description
The secondary objectives of this study are:
- / - to assess the metrological characteristics of the data from inertial sensors (FOX © HiKoB) for the reconstruction of the movement in comparison with reference systems (GaitRite or Zebris systems, VICON) in terms of:
- Ability to determine the walking speed, stride length, the acceleration of plantar flexion at the beginning of the weight-bearing phase B. Ability to objectify performance reduction during a 6 minute test. C. Ability to identify different types of movement: simple walking, turn, obstacle clearance, staircase.
- / - to analyze the EMG signal upon voluntary dorsiflexion of the foot of the paretic side from a sitting position before and after a fatigue test (objective D)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | –The study population consists of patients whose age is between 20 and 75 years and who experienced a supra-tentorial ischemic or hemorrhagic stroke. The study covers inpatients or patients consultating in the neurological rehabilitation service (NHS) at the Grau du Roi Medical Center, Nîmes University Hospital. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients whose age is between 20 and 75 years and who experienced a supra-tentorial ischemic or hemorrhagic stroke. The study covers inpatients or patients consultating in the neurological rehabilitation service (NHS) at the Grau du Roi Medical Center, Nîmes University Hospital.
Key inclusion criteria (4 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Stroke, ischemic or hemorrhagic, supra-tentorial, regardless of the post-stroke period
- The patient can walk 10m without human help, with or without a cane and has a foot elevator deficit requiring the use of technical assistance or causing a walking defect
Key exclusion criteria (8 listed)
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient or his/her representative refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Dorsiflexion (°) at the beginning of a step
Time frame: Day 0
Dorsiflexion (°) in the middle of the oscillating phase
Time frame: Day 0
7 secondary outcomes
Walking speed
Time frame: Day 0
Stride length
Time frame: Day 0
Maximal angular speed at the ankle between the moment when the heel touches the ground and the moment where the foot is flat (°/s)
Time frame: Day 0
6 minute walking test: average dorsiflexion ankle measured between 15 seconds and 30 seconds
Time frame: Day 0
6 minute walking test: average dorsiflexion ankle measured between 30 seconds and 5 min 5 min 45 seconds
Time frame: Day 0
Detection of obstables: yes/no
Time frame: Day 0
EMG signal (%) during voluntary dorsiflexion of the foot of the paretic side in a sitting position before and after fatigue test
Time frame: Day 0
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 Nov 2025.
- Results publication: PubMed 30441133Sijobert B, Feuvrier F, Froger J, Guiraud D, Coste CA. A sensor fusion approach for inertial sensors based 3D kinematics and pathological gait assessments: toward an adaptive control of stimulation in post-stroke subjects. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:3497-3500. doi: 10.1109/EMBC.2018.8512985.
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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.
Jérôme Froger, MD principal investigator
Centre Hospitalier Universitaire de Nīmes
Cristine Azevedo Coste study director
DEMAR INRIA / LIRMM, 161 rue Ada, 30392 Montpellier Cedex 5
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Centre Hospitalier Universitaire de Nīmes 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 4 inclusion and 8 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 Nov 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 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?
Dorsiflexion (°) at the beginning of a step (time frame: Day 0). The study lists 2 primary outcomes in all. 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 NCT02598154, 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 Nov 2025.