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

Completed

• Conditions: Stroke

• Registration Number: NCT02598154
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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)

Study Timeline

• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Study Start: 2016-05-20
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-18
• Last Update Posted: 2017-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Dorsiflexion (°) in the middle of the oscillating phase	Day 0
Dorsiflexion (°) at the beginning of a step	Day 0

Secondary Outcome Measures

Name	Time	Method
EMG signal (%) during voluntary dorsiflexion of the foot of the paretic side in a sitting position before and after fatigue test	Day 0
Walking speed	Day 0
Stride length	Day 0
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 seconds	Day 0
6 minute walking test: average dorsiflexion ankle measured between 30 seconds and 5 min 5 min 45 seconds	Day 0
Detection of obstables: yes/no	Day 0

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France