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FES-induced Muscular Control of the Knee on Balance and Gait Retraining After a Stroke or a Cerebral Injury (GONIOSEF)

Primary Purpose

Hemiplegia, Gait, Hemiplegic, Gait, Unsteady

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Functional Electrical Stimulation FES
Sponsored by
Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hemiplegia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age > or = 18 years
  • Cerebral injury or stroke
  • Interval time since the onset of the neurological event: min 8 weeks (in case of an acute cerebral damage) or at a any time in case of a chronic affection
  • Surface electrical stimulation of quadriceps and hamstrings possible
  • Free range of motion in lower limbs
  • Ankle-foot orthosis, dynamic or static
  • Limited perimeter distance < 50 meters with or without walking technical aids

Exclusion Criteria:

  • Knee-Ankle-Foot orthosis is required
  • Body mass index > or = 30
  • Thrombophlebitis
  • Muscular pathology
  • Unstable Cardio-Vascular pathology
  • Lower limb prosthesis
  • Unstable seizures
  • Orthostatic hypotension
  • Recent fracture in lower limbs (<12 months)
  • Pacemaker
  • Pregnancy
  • Betablockers

Sites / Locations

  • Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FES in patients with hemiplegia

Arm Description

Patients will be equipped with 5 inertial measurement units. Two wireless bluetooth pressure insoles will be connected to the Raspberry. Electrical stimulation will be delivered via a wireless stimulator to the quadriceps and hamstrings via surface electrodes. Insoles will be used to online analyze Paretic Foot Support to discriminate between stance and swing phases. Stimulation will also be delivered just before initial contact at the end of swing phase. In stance phase, stimulation will be triggered either to quadriceps or hamstrings, depending on the paretic knee angle estimation relatively to the knee angle setpoint defined by the practitioner as the optimal flexion during stance phase (around 5°).

Outcomes

Primary Outcome Measures

Assymetry of stance phase
symmetry ratio of stance duration between paretic and non-paretic limbs
Assymetry of weight support in stance phase
percentage of weight supported during stance phase relatively to the total weight

Secondary Outcome Measures

Comfortable walking speed
The preferred walking speed at which the participant choose to walk and speed at which there is least energy consumption per unit distance
Cadence
The total number of full cycles on a 10m walking path
Physiological Cost Index (PCI)
Energy cost in walking. PCI is the ratio of the difference in working and resting mean heart rates (bpm) and the self-selected (comfort) walking speed (m/min). The PCI value reflects the energy expenditure for walking and is expressed as heartbeats per meter.
Borg score of the exercise intensity
Rating of perceived exertion while walking. Perceived effort of walking using a Borg scale from 6 (no exertion) to 20 (maximum exertion) evaluated by the participant.

Full Information

First Posted
May 16, 2018
Last Updated
May 5, 2020
Sponsor
Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie
Collaborators
Institut National de Recherche en Informatique et en Automatique
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1. Study Identification

Unique Protocol Identification Number
NCT04381546
Brief Title
FES-induced Muscular Control of the Knee on Balance and Gait Retraining After a Stroke or a Cerebral Injury
Acronym
GONIOSEF
Official Title
Projet GonioSEF: Etude de faisabilité d'un Dispositif d'amélioration du défaut de Report d'Appui Pendant la Marche en Phase Portante Chez Des Sujets présentant Une Atteinte du système Nerveux Central
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
April 26, 2018 (Actual)
Primary Completion Date
April 30, 2019 (Actual)
Study Completion Date
June 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie
Collaborators
Institut National de Recherche en Informatique et en Automatique

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The main hypothesis of the present study is that a safer knee joint is likely to encourage post stroke patients at an early stage to rely on their hemiparetic leg and transfer their weight onto it while walking. The main purpose of the present work is to assess the feasibility of FES-induced muscular control of the hemiplegic knee joint in order to improve stance phase support symmetry recovery in individuals with post stroke hemiplegia. Functional electrical stimulation (FES) is delivered to the quadriceps and hamstrings of the paretic limb based on the real-time estimation of the knee angle and support phase.
Detailed Description
The process of gait recovery in patients with severe post-stroke hemiplegia requires a significant investment and effort for both the patient and the therapist and is not always leading to a safe and autonomous gait. Increasing the chances for the patients of regaining a functional walking gait within limited timeframes is a challenge. Several studies have focused their attention on the neurological foot in the chronic phase because a poorly controlled foot dorsiflexion is a factor limiting gait recovery and increasing fall risk. Functional Electrical Stimulation (FES) can be used as an alternative to an orthosis to restore walking by activating paralyzed muscles. FES has been extensively studied to correct drop foot by activating foot dorsiflexors or inducing a withdrawal reflex. Few studies have considered knee joint which has a major role, especially for the quality of the support, and this over the entire cycle of walking. In the initial phase after stroke, ensuring a safe knee control remains difficult because of the associated disorders including the lack of proprioceptive feedback. Classical observed disorders in this population are knee hyperextension during the stance phase (genu recurvatum) and flexed knees (crouch gait). Fixed orthoses are usually used to prevent this by limiting knee flexion or extension over the gait. FES is also an alternative to produce appropriately timed knee flexion or extension. Bioness L300 Plus© device proposes a thigh cuff embedding electrodes stimulating the quadriceps muscles to extend knee at the appropriate time during gait based on shank angle observation. Previous studies have investigated the contribution of quadriceps and gluteus maximus stimulation in improving standing balance and weight transfer or hamstrings stimulation associated to foot dorsiflexors stimulation in improving gait performance. One of the main objectives of an early rehabilitation is to encourage patients with hemiplegia to rely on their paretic leg and to transfer their weight onto it while walking. Depending on the gait phase, the knee extension and flexion are restricted to a safety range by the adaptive delivery of quadriceps and hamstring electrical stimulation. A sensor network detects gait phases and knee angle evolution from which stimulation levels are modulated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Gait, Hemiplegic, Gait, Unsteady, Rehabilitation

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study
Masking
None (Open Label)
Masking Description
FES-based control of knee joint to reduce stance phase asymmetry during gait in patients with post-stroke hemiplegia
Allocation
N/A
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FES in patients with hemiplegia
Arm Type
Experimental
Arm Description
Patients will be equipped with 5 inertial measurement units. Two wireless bluetooth pressure insoles will be connected to the Raspberry. Electrical stimulation will be delivered via a wireless stimulator to the quadriceps and hamstrings via surface electrodes. Insoles will be used to online analyze Paretic Foot Support to discriminate between stance and swing phases. Stimulation will also be delivered just before initial contact at the end of swing phase. In stance phase, stimulation will be triggered either to quadriceps or hamstrings, depending on the paretic knee angle estimation relatively to the knee angle setpoint defined by the practitioner as the optimal flexion during stance phase (around 5°).
Intervention Type
Other
Intervention Name(s)
Functional Electrical Stimulation FES
Intervention Description
Functional electrical stimulation (FES) is delivered to the quadriceps and hamstrings of the paretic limb in patients with hemiplegia. It is based on the real-time estimation of the knee angle and support phase during gait.
Primary Outcome Measure Information:
Title
Assymetry of stance phase
Description
symmetry ratio of stance duration between paretic and non-paretic limbs
Time Frame
24 hours
Title
Assymetry of weight support in stance phase
Description
percentage of weight supported during stance phase relatively to the total weight
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Comfortable walking speed
Description
The preferred walking speed at which the participant choose to walk and speed at which there is least energy consumption per unit distance
Time Frame
24 hours
Title
Cadence
Description
The total number of full cycles on a 10m walking path
Time Frame
24 hours
Title
Physiological Cost Index (PCI)
Description
Energy cost in walking. PCI is the ratio of the difference in working and resting mean heart rates (bpm) and the self-selected (comfort) walking speed (m/min). The PCI value reflects the energy expenditure for walking and is expressed as heartbeats per meter.
Time Frame
24 hours
Title
Borg score of the exercise intensity
Description
Rating of perceived exertion while walking. Perceived effort of walking using a Borg scale from 6 (no exertion) to 20 (maximum exertion) evaluated by the participant.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age > or = 18 years Cerebral injury or stroke Interval time since the onset of the neurological event: min 8 weeks (in case of an acute cerebral damage) or at a any time in case of a chronic affection Surface electrical stimulation of quadriceps and hamstrings possible Free range of motion in lower limbs Ankle-foot orthosis, dynamic or static Limited perimeter distance < 50 meters with or without walking technical aids Exclusion Criteria: Knee-Ankle-Foot orthosis is required Body mass index > or = 30 Thrombophlebitis Muscular pathology Unstable Cardio-Vascular pathology Lower limb prosthesis Unstable seizures Orthostatic hypotension Recent fracture in lower limbs (<12 months) Pacemaker Pregnancy Betablockers
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Fattal, MD, PhD
Organizational Affiliation
Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie
City
Menucourt
ZIP/Postal Code
95180
Country
France

12. IPD Sharing Statement

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FES-induced Muscular Control of the Knee on Balance and Gait Retraining After a Stroke or a Cerebral Injury

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