Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System

Study Overview
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Brief Summary
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Functional electrical stimulation is a modality of motor rehabilitation that consists of the programmed application of bursts of electrical current to the affected neuromuscular region that aims to improve muscle strength, increase the range of motion, facilitate movement control and decrease spasticity. The present study aimed to measure the changes in the biomechanics of the gait of people with Stroke after training with functional electrical stimulation for the lower extremities.

Detailed Description
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Stroke is one of the leading causes of mortality, morbidity and disability in adults in developed countries. Survivors may suffer several neurological deficits or deficiencies, such as hemiparesis, communication disorders, cognitive deficits and visuospatial perception disorders. Hemiplegia is a par loss of hemi-body voluntary motricity following a brain injury, usually resulting in alterations of the locomotor system with persistent disorders of movement and posture. Hemiplegia significantly affects gait performance. Gait recovery is an important objective in the rehabilitation program for stroke patients.The currently available treatment techniques include classical techniques of gait rehabilitation, functional electrical stimulation, electromechanic devices, robotic devices and brain-computer interfaces, among others.The evidence suggest that the combination of different rehabilitation strategies is more effective than conventional rehabilitation techniques alone. Technology-based rehabilitation methods such as robotic devices need more research to demonstrate their effects on gait recovery. The present study aimed to identify the changes in the gait characteristics of subjects with stroke after a treatment program with FES for the lower extremities through instrumental gait analysis.

Official Title
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Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System

Conditions
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Stroke

Intervention / Treatment
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* Device: Cycle-ergometer training assisted by FES for lower extremities


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral lower extremity paresis haemorrhagic or ischemic stroke a minimum of six months after the acute infarction/onset of the disease full passive range of motion in lower extremity or at least at neutral position be able to stand freely be able to walk with or without aid for at least 20 meters in less than 2 minutes Exclusion Criteria: peripheral nervous system pathology epilepsy weight over 100 kg no cognitive ability to follow the study instructions pregnancy use of implanted devices instable lower extremity joints or fixed contracture

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robot-assisted Rehabilitation<br>Participants will receive Functional Electrical Stimulation (FES) training with a lower extremity cycle-ergometer (MOTOmed Viva 2, Reck GmbH., Germany) and a 6-channel FES Device (TrainFES, Biomedical Devices SpA, Chile). Patients will perform lower limb exercises assisted by the device. Training involve 24 sessions, 3 sessions per week for 8 weeks, each lasting about 45 minutes. | Device: Cycle-ergometer training assisted by FES for lower extremities<br>* The intervention consists of FES treatment sessions on a cycle ergometer for the lower extremities. Each subject received 24 sessions lasting 45 minutes each and a frequency of 3 sessions per week. The sessions will be applied by a physiotherapist with experience in electrotherapy. A 6-channel FES device (TrainFES, Biomedical Devices SpA, Chile) will be used, which consists of a stimulator unit of 95x50x30mm and 100g of weight coupled to the motorized cycle ergometer (MOTOmed Viva 2, Reck GmbH., Germany), a remote user interface consisting of an android application for the configuration of the stimulation via Bluetooth 3.1, and an inertial measurement unit positioned on the rotation axis of the cycle ergometer to detect the rotations and trigger the synchronized electrical stimulation according to the stimulation pattern pre-configured for the pedaling exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Deviation Index Baseline | Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system. | Baseline | 
| Gait Deviation Index Post-Intervention | Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait Speed Baseline | Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system. | Baseline | 
| Gait Speed Post-intervention | Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Hemiparesis, Gait, Functional Electrical Stimulation, Rehabilitation, Gait Deviation Index