Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile

NCT ID: NCT04228224

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-01
• Study Completion Date: 2020-03-31

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Robot-assisted Rehabilitation

Participants will receive Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain). Patients will perform lower limb exercises assisted by the device. Training involve 24 sessions, 2 sessions per week for 12 weeks, each lasting about 1 hour.

Group Type: EXPERIMENTAL

Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain)

Intervention Type: DEVICE

The H3 is a powered lower extremity exoskeleton with actuated at hips, knees and ankles joints. A novel control software has been design and implemented in this device, which allows selective joint movement and recording of data from each rehabilitation session.

Conventional Gait Rehabilitation

Participants in this group will perform conventional gait rehabilitation on a rehabilitation institution with assistance of a physical therapist. Training involve 24 sessions, 2 sessions per week, each session lasting about 1 hour.

Group Type: ACTIVE_COMPARATOR

Conventional gait rehabilitation

Intervention Type: BEHAVIORAL

Conventional gait rehabilitation consist in walking and other applicable lower limb exercises performed by participants with assistance of a physical therapist.

Interventions

Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain)

The H3 is a powered lower extremity exoskeleton with actuated at hips, knees and ankles joints. A novel control software has been design and implemented in this device, which allows selective joint movement and recording of data from each rehabilitation session.

Intervention Type: DEVICE

Conventional gait rehabilitation

Conventional gait rehabilitation consist in walking and other applicable lower limb exercises performed by participants with assistance of a physical therapist.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Corporación de Rehabilitación Club de Leones Cruz del Sur

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Asterio H Andrade Gallardo, MSc.

Role: STUDY_CHAIR

Corporación de Rehabilitacion Club de Leones Cruz del Sur

Locations

Corporación de Rehabilitación Club de Leones Cruz del Sur

Punta Arenas, Region of Magallanes, Chile

Countries

Chile

References

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.

Reference Type: BACKGROUND

PMID: 15788341 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22165907 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26076696 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26381192 (View on PubMed)

Other Identifiers

CorporacionRCLCS0001

Identifier Type: -

Identifier Source: org_study_id