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

Not Applicable

• Conditions: Stroke
• Interventions: Device: Cycle-ergometer training assisted by FES for lower extremities

• Registration Number: NCT04473391
• Lead Sponsor: Corporación de Rehabilitación Club de Leones Cruz del Sur

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-01
• Status Verified: 2020-07
• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-13
• Last Update Submitted: 2020-07-13
• Study First Posted: 2020-07-16
• Last Update Posted: 2020-07-16
• Primary Completion: 2020-12-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robot-assisted Rehabilitation	Cycle-ergometer training assisted by FES for lower extremities	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.

Primary Outcome Measures

Name	Time	Method
Gait Deviation Index Baseline	Baseline	Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Gait Deviation Index Post-Intervention	12 weeks	Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.

Secondary Outcome Measures

Name	Time	Method
Gait Speed Baseline	Baseline	Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.
Gait Speed Post-intervention	12 weeks	Gait Speed will be calculated for each patient using a 3D VICON infra-red camera system.

Trial Locations

Locations (1)

Corporación de Rehabilitación Club de Leones Cruz del Sur; 🇨🇱 Punta Arenas, XII Región, Chile