Clinical trial NCT02598154: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-11-05
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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)

Eligibility criteria: 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:

* 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

Primary outcomes:
measure: Dorsiflexion (°) at the beginning of a step
timeFrame: Day 0
measure: Dorsiflexion (°) in the middle of the oscillating phase
timeFrame: Day 0
Secondary outcomes:
measure: Walking speed
timeFrame: Day 0
measure: Stride length
timeFrame: Day 0
measure: Maximal angular speed at the ankle between the moment when the heel touches the ground and the moment where the foot is flat (°/s)
timeFrame: Day 0
measure: 6 minute walking test: average dorsiflexion ankle measured between 15 seconds and 30 seconds
timeFrame: Day 0
measure: 6 minute walking test: average dorsiflexion ankle measured between 30 seconds and 5 min 5 min 45 seconds
timeFrame: Day 0
measure: Detection of obstables: yes/no
timeFrame: Day 0
measure: EMG signal (%) during voluntary dorsiflexion of the foot of the paretic side in a sitting position before and after fatigue test
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jérôme Froger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DEMAR INRIA / LIRMM, 161 rue Ada, 30392 Montpellier Cedex 5
name: Cristine Azevedo Coste
role: STUDY_DIRECTOR
References: