NCT04568928

Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice

Implementation of Locomotor Training Program Using a Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice for Persons With an Incomplete Spinal Cord Injury - WHY and HOW to do it?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Laval University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

After partial spinal cord injury, gait deficits may be present and often remain even after intensive rehabilitation. New robotic technologies have recently emerged to help augment the extent of rehabilitation. However, these are complex tools to integrate into clinical practice and little is known about the potential factors that may influence the uptake of a locomotor program using this technology by clinicians. The goal of this project is to bring together researchers, administrators, clinicians and patients to define and implement an overground robotized gait training program in clinic. We will also investigate the added value of leg and trunk muscle stimulation combined with robotic walking training, to see if it could enhance recovery.

Detailed description

Powered exoskeleton technology represents a promising rehabilitation intervention for persons with incomplete spinal cord injury (iSCI). The overall aim of the present study is to investigate the implementability of an overground locomotor training program using a powered exoskeleton in persons with a subacute iSCI at the Institut de réadaptation en déficience physique de Québec, with and without functional electrical stimulation (FES). Over the 2-year period of the project, a logic model will be co-developed with stakeholders to support clinicians and administrators in the management of the locomotor training program. Using qualitative and quantitative research methods, we will evaluate the feasibility and perceived barriers/facilitators to the implementation in clinical practice of the training program. Finally, a pre-post design with individuals receiving the intervention either combined with FES or not, will allow quantifying of the benefits of combining FES in addition to robotic gait training on functional walking capacity in persons with a subacute iSCI.

Conditions

• Incomplete Spinal Cord Injury

Interventions

Type	Name	Description
DEVICE	OLTP/PE + FES	12 sessions OLTP/PE + FES

Timeline

• Start date: 2020-12-10
• Primary completion: 2023-08-01
• Completion: 2023-08-01
• First posted: 2020-09-29
• Last updated: 2022-08-24

Locations

1 site across 1 country: Canada