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

Stroke Clinical Trial

— MASEA 2  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598154
• Other study ID #: LOCAL/2015/JF-01
• Secondary ID: 2015-A00572-47
• Status: Completed
• Phase: N/A
• First received: November 4, 2015
• Last updated: August 18, 2017
• Start date: May 20, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: August 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dorsiflexion (°) at the beginning of a step		Day 0
Primary	Dorsiflexion (°) in the middle of the oscillating phase		Day 0
Secondary	Walking speed		Day 0
Secondary	Stride length		Day 0
Secondary	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
Secondary	6 minute walking test: average dorsiflexion ankle measured between 15 seconds and 30 seconds		Day 0
Secondary	6 minute walking test: average dorsiflexion ankle measured between 30 seconds and 5 min 5 min 45 seconds		Day 0
Secondary	Detection of obstables: yes/no		Day 0
Secondary	EMG signal (%) during voluntary dorsiflexion of the foot of the paretic side in a sitting position before and after fatigue test		Day 0