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Search / Trial NCT04568928

Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice

Launched by LAVAL UNIVERSITY · Sep 24, 2020

Trial Information

Current as of September 17, 2025

Unknown status

Keywords

Exoskeleton, Locomotor Training, Fes, Sci

ClinConnect Summary

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 th...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • General
  • Measure between 5'1" and 6'3" (1.5 and 1.9m)
  • Weigh less than 200 pounds (90kg)
  • Present a diagnosis of incomplete spinal cord injury
  • Have the ability to maintain a standing position and/or have therapeutic walking ability at Stage 1B or more of the Rick Hansen Institute SCI Standing and Walking Assessment Toolkit
  • Present sufficient upper extremity strength and function to use a walker with wheels
  • Femur length between 37 and 49cm
  • Width of hips when seated \<42 cm
  • Obtain approval from a physician to participate in the project
  • Standing tolerance \>15 minutes
  • For FES:
  • Respond favourably to functional electrical stimulation (FES) of the main lower extremity muscle groups: (gluteus, quadriceps, hamstrings, dorsiflexors, etc.) as determined by a physiotherapist.
  • Have no contraindications to FES according to the guidelines of the Canadian physiotherapy association (CPA).
  • Exclusion Criteria:
  • General:
  • Poor fit of the exoskeleton as determined by the research team
  • Present contraindications to the use of the Indego® exoskeleton as described by the company
  • Present lower extremity skin lesions or sores
  • * Any medical condition or co-morbidity that may impair collaboration and participation or making it unsafe to wear the exoskeleton, for example (non-exhaustive list) :
  • Disabling pain.
  • Significant sensory disturbances in the lower limbs that limit safe walking.
  • Cognitive disorders that impair the ability to collaborate.
  • Osteoporosis.
  • Unconsolidated fractures of the lower limbs.
  • Uncontrolled reflex dysautonomia.
  • Severe peripheral vascular disease.
  • Severe heart failure.
  • Severe, active infection
  • FES Exclusion Criteria
  • Pregnancy;
  • Presence of a malignant tumor
  • Deep vein thrombosis
  • Hemorrhagic condition
  • Infection or osteomyelitis
  • Presence of weakened/damaged skin
  • Circulatory disorders
  • Epilepsy
  • Electronic implant

About Laval University

Laval University is a prestigious research institution located in Quebec, Canada, renowned for its commitment to advancing knowledge and innovation in various fields, including health sciences. The university actively engages in clinical trials aimed at exploring new therapeutic interventions and improving patient outcomes. With a strong emphasis on ethical standards and rigorous scientific methodologies, Laval University collaborates with multidisciplinary teams of researchers, healthcare professionals, and industry partners to conduct high-quality clinical research. Its state-of-the-art facilities and dedication to fostering a culture of inquiry position Laval University as a leader in clinical research, contributing significantly to the understanding and treatment of diverse medical conditions.

Locations

Quebec City, Quebec, Canada

Patients applied

0 patients applied

Trial Officials

François Routhier, PhD

Principal Investigator

Laval University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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