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

Rehabilitation Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04381546
• Other study ID #: 2017-A03611-52
• Status: Completed
• Phase: N/A
• Start date: April 26, 2018
• Est. completion date: June 30, 2019

Study information

• Verified date: May 2020
• Source: Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gait Disorders, Neurologic
• Gait, Hemiplegic
• Gait, Unsteady
• Hemiplegia
• Rehabilitation

Intervention

Other:
• Functional Electrical Stimulation FES
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.

Locations

Country	Name	City	State
France	Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie	Menucourt

Sponsors (2)

Lead Sponsor	Collaborator
Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie	Institut National de Recherche en Informatique et en Automatique

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assymetry of stance phase	symmetry ratio of stance duration between paretic and non-paretic limbs	24 hours
Primary	Assymetry of weight support in stance phase	percentage of weight supported during stance phase relatively to the total weight	24 hours
Secondary	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	24 hours
Secondary	Cadence	The total number of full cycles on a 10m walking path	24 hours
Secondary	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.	24 hours
Secondary	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.	24 hours