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

NCT ID: NCT02598154

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-20
• Study Completion Date: 2017-06-30

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)

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jérôme Froger, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nîmes

Cristine Azevedo Coste

Role: STUDY_DIRECTOR

DEMAR INRIA / LIRMM, 161 rue Ada, 30392 Montpellier Cedex 5

Locations

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, , France

Countries

France

References

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.

Reference Type: RESULT

PMID: 30441133 (View on PubMed)

Other Identifiers

2015-A00572-47

Identifier Type: OTHER

Identifier Source: secondary_id

LOCAL/2015/JF-01

Identifier Type: -

Identifier Source: org_study_id