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CompletedNCT02598154MASEA 2Updated Nov 19, 2025

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 in Stroke, sponsored by Centre Hospitalier Universitaire de Nīmes. Completed at 1 site in France. Open to participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-19.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
29
Ages
20 Years to 75 Years
Sex
All
01

Study 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 oscillating phase.

Read the detailed description

The secondary objectives of this study are:

  1. / - 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:

    A. 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.

  2. / - 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)
02

Conditions studied

  • Stroke

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03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 29 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 587 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
29 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Dorsiflexion (°) at the beginning of a step

    Time frame: Day 0

  2. Dorsiflexion (°) in the middle of the oscillating phase

    Time frame: Day 0

Secondary outcomes

  1. Walking speed

    Time frame: Day 0

  2. Stride length

    Time frame: Day 0

  3. 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

  4. 6 minute walking test: average dorsiflexion ankle measured between 15 seconds and 30 seconds

    Time frame: Day 0

  5. 6 minute walking test: average dorsiflexion ankle measured between 30 seconds and 5 min 5 min 45 seconds

    Time frame: Day 0

  6. Detection of obstables: yes/no

    Time frame: Day 0

  7. 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

07

Study locations

1 site
  • CHRU de Nîmes - Hôpital Universitaire Carémeau
    Nîmes, 30029, France
08

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02598154
Lead sponsor
Centre Hospitalier Universitaire de Nīmes
Responsible party
Sponsor
First posted
Nov 5, 2015
Start date
May 20, 2016
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Last update
Nov 19, 2025

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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