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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Dorsiflexion (°) in the middle of the oscillating phase
Study Overview
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:
- / - 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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Dorsiflexion (°) in the middle of the oscillating phase
Time Frame: Day 0
Dorsiflexion (°) at the beginning of a step
Time Frame: Day 0
Secondary Outcomes
- 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)