Skip to content

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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02598154
Acronym
MASEA 2
Enrollment
29
Registered
2015-11-05
Start date
2016-05-20
Completion date
2017-06-30
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stroke

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)

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Dorsiflexion (°) at the beginning of a stepDay 0
Dorsiflexion (°) in the middle of the oscillating phaseDay 0

Secondary

MeasureTime frame
Maximal angular speed at the ankle between the moment when the heel touches the ground and the moment where the foot is flat (°/s)Day 0
6 minute walking test: average dorsiflexion ankle measured between 15 seconds and 30 secondsDay 0
Walking speedDay 0
Detection of obstables: yes/noDay 0
EMG signal (%) during voluntary dorsiflexion of the foot of the paretic side in a sitting position before and after fatigue testDay 0
6 minute walking test: average dorsiflexion ankle measured between 30 seconds and 5 min 5 min 45 secondsDay 0
Stride lengthDay 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026