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 (MASEA 2)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Stroke

Study type: Observational

Funder types: Other

Identifiers

NCT02598154

LOCAL/2015/JF-01

2015-A00572-47 (Other Identifier)

Details and patient eligibility

About

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.

Full 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)

Enrollment: 29 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

29 participants in 1 patient group

Study population

Description:

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.