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"

Completed

Phase N/A Results N/A

Trial Description

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

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial 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.

Outcomes

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

Sponsors