Clinical trial NCT04228224: Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile
Official title: Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Hemiparesis
Gait
Brain-Computer Interface
Rehabilitation
Exoskeleton
Lead sponsor: Corporación de Rehabilitación Club de Leones Cruz del Sur
Sponsor class: OTHER
First posted: 2020-01-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research will study the effects of a rehabilitation program assisted by a powered lower extremity exoskeleton in patients after stroke. It will compare clinical and biomechanical features of patients at baseline and after intervention. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.

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.

This study will assess the effects of a rehabilitation program with a powered lower extremity exoskeleton in people with stroke. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.

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: Maximal muscle strength Baseline
timeFrame: Baseline
measure: Maximal muscle strength Post-Intervention
timeFrame: 12 weeks
measure: Distance in 6 Minute Walk Test (6MWT) Baseline
timeFrame: Baseline
measure: Distance in 6 Minute Walk Test (6MWT) Post-Intervention
timeFrame: 12 weeks
measure: Muscle tone measured using modified ashworth scale (MAS) Baseline
timeFrame: Baseline
measure: Muscle tone measured using modified ashworth scale (MAS) Post-Intervention
timeFrame: 12 weeks
measure: Passive range of motion Baseline
timeFrame: Baseline
measure: Passive range of motion Post-Intervention
timeFrame: 12 weeks
measure: 10 meter walk test Baseline
timeFrame: Baseline
measure: 10 meter walk test Post-Intervention
timeFrame: 12 weeks
measure: Timed Up and Go Baseline
timeFrame: Baseline
measure: Timed Up and Go Post-Intervention
timeFrame: 12 weeks
measure: Berg Balance Scale Baseline
timeFrame: Baseline
measure: Berg Balance Scale Post-Intervention
timeFrame: 12 weeks
measure: Functional Ambulation Classification (FAC) Baseline
timeFrame: Baseline
measure: Functional Ambulation Classification (FAC) Post-Intervention
timeFrame: 12 weeks
measure: Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology
timeFrame: 12 weeks
measure: Medical Research Council test (MRC) Baseline
timeFrame: Baseline
measure: Medical Research Council test (MRC) Post-Intervention
timeFrame: 12 weeks
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: Bortole M, Venkatakrishnan A, Zhu F, Moreno JC, Francisco GE, Pons JL, Contreras-Vidal JL. The H2 robotic exoskeleton for gait rehabilitation after stroke: early findings from a clinical study. J Neuroeng Rehabil. 2015 Jun 17;12:54. doi: 10.1186/s12984-015-0048-y.
citation: Wallard L, Dietrich G, Kerlirzin Y, Bredin J. Effects of robotic gait rehabilitation on biomechanical parameters in the chronic hemiplegic patients. Neurophysiol Clin. 2015 Sep;45(3):215-9. doi: 10.1016/j.neucli.2015.03.002. Epub 2015 Sep 14.