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Completed

NCT Number: NCT02598154

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

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.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

The secondary objectives of this study are:

  • / - 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.

  • / - 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Dorsiflexion (°) at the beginning of a step

    Time frame: Day 0

  2. Dorsiflexion (°) in the middle of the oscillating phase

    Time frame: Day 0

Secondary outcomes

  1. Walking speed

    Time frame: Day 0

  2. Stride length

    Time frame: Day 0

  3. Maximal angular speed at the ankle between the moment when the heel touches the ground and the moment where the foot is flat (°/s)

    Time frame: Day 0

  4. 6 minute walking test: average dorsiflexion ankle measured between 15 seconds and 30 seconds

    Time frame: Day 0

  5. 6 minute walking test: average dorsiflexion ankle measured between 30 seconds and 5 min 5 min 45 seconds

    Time frame: Day 0

  6. Detection of obstables: yes/no

    Time frame: Day 0

  7. EMG signal (%) during voluntary dorsiflexion of the foot of the paretic side in a sitting position before and after fatigue test

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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

Acronym: MASEA 2

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 5, 2015
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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