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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04381546
Acronym
GONIOSEF
Enrollment
11
Registered
2020-05-11
Start date
2018-04-26
Completion date
2019-06-30
Last updated
2020-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gait, Hemiplegic, Gait, Unsteady, Hemiplegia, Rehabilitation

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.

Interventions

OTHERFunctional 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.

Sponsors

Institut National de Recherche en Informatique et en Automatique
CollaboratorOTHER
Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Masking description

FES-based control of knee joint to reduce stance phase asymmetry during gait in patients with post-stroke hemiplegia

Intervention model description

Feasibility study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assymetry of stance phase24 hourssymmetry ratio of stance duration between paretic and non-paretic limbs
Assymetry of weight support in stance phase24 hourspercentage of weight supported during stance phase relatively to the total weight

Secondary

MeasureTime frameDescription
Comfortable walking speed24 hoursThe preferred walking speed at which the participant choose to walk and speed at which there is least energy consumption per unit distance
Cadence24 hoursThe total number of full cycles on a 10m walking path
Physiological Cost Index (PCI)24 hoursEnergy 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 intensity24 hoursRating 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026