Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice

Last updated: August 22, 2022
Sponsor: Laval University
Overall Status: Active - Enrolling

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

N/A

Clinical Study ID

NCT04568928
2020-2002
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 walkingability at Stage 1B or more of the Rick Hansen Institute SCI Standing and WalkingAssessment 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 lowerextremity muscle groups: (gluteus, quadriceps, hamstrings, dorsiflexors, etc.) asdetermined by a physiotherapist.
  • Have no contraindications to FES according to the guidelines of the Canadianphysiotherapy association (CPA).

Exclusion

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 thecompany
  • Present lower extremity skin lesions or sores
  • Any medical condition or co-morbidity that may impair collaboration and participationor 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

Study Design

Total Participants: 10
Study Start date:
December 10, 2020
Estimated Completion Date:
August 31, 2023

Study 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.

Connect with a study center

  • Laval University

    Quebec City, Quebec
    Canada

    Site Not Available

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