Clinical trial NCT04473391: Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System
Official title: Instrumental Gait Analysis on People With Stroke After Rehabilitation With a Synchronized FES and Cycle Ergometer System
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Stroke
Hemiparesis
Gait
Functional Electrical Stimulation
Rehabilitation
Gait Deviation Index
Lead sponsor: Corporación de Rehabilitación Club de Leones Cruz del Sur
Sponsor class: OTHER
First posted: 2020-07-16
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gait Deviation Index Baseline
timeFrame: Baseline
measure: Gait Deviation Index Post-Intervention
timeFrame: 12 weeks
Secondary outcomes:
measure: Gait Speed Baseline
timeFrame: Baseline
measure: Gait Speed Post-intervention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Punta Arenas
country: Chile
facility: Corporación de Rehabilitación Club de Leones Cruz del Sur
state: XII Región
Study officials:
affiliation: Corporación de Rehabilitacion Club de Leones Cruz del Sur
name: Asterio H Andrade Gallardo, MSc.
role: STUDY_CHAIR
References:
citation: Flansbjer UB, Holmback AM, Downham D, Patten C, Lexell J. Reliability of gait performance tests in men and women with hemiparesis after stroke. J Rehabil Med. 2005 Mar;37(2):75-82. doi: 10.1080/16501970410017215.
citation: Belda-Lois JM, Mena-del Horno S, Bermejo-Bosch I, Moreno JC, Pons JL, Farina D, Iosa M, Molinari M, Tamburella F, Ramos A, Caria A, Solis-Escalante T, Brunner C, Rea M. Rehabilitation of gait after stroke: a review towards a top-down approach. J Neuroeng Rehabil. 2011 Dec 13;8:66. doi: 10.1186/1743-0003-8-66.
citation: Gage JR. Gait analysis. An essential tool in the treatment of cerebral palsy. Clin Orthop Relat Res. 1993 Mar;(288):126-34.
citation: Schwartz MH, Rozumalski A. The Gait Deviation Index: a new comprehensive index of gait pathology. Gait Posture. 2008 Oct;28(3):351-7. doi: 10.1016/j.gaitpost.2008.05.001. Epub 2008 Jun 18.
citation: Popovic DB, Sinkaer T, Popovic MB. Electrical stimulation as a means for achieving recovery of function in stroke patients. NeuroRehabilitation. 2009;25(1):45-58. doi: 10.3233/NRE-2009-0498.