Clinical trial NCT04568928: Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice
Official title: 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?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Incomplete Spinal Cord Injury
Keywords: Exoskeleton, locomotor training, FES, SCI
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Praxis Spinal Cord Institute
First posted: 2020-09-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Change in Modified Six Minute Walk Test (6MWT)
timeFrame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
measure: Change in 10 meter Walk Test (10mWT)
timeFrame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
measure: Change in Modified Timed Up and Go test (TUG)
timeFrame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
measure: Change in Walking Index for Spinal Cord Injury (WISCI-II)
timeFrame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
Secondary outcomes:
measure: Change in Brief pain inventory questionnaire
timeFrame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
measure: Change in Spinal Cord Injury Secondary Conditions scale (SCI-SCS)
timeFrame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
measure: Change in the Modified Ashworth Scale (MAS)
timeFrame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
measure: Change in electromyographic (EMG) activity of the tibialis anterior, triceps surae, quadriceps, hamstrings muscles during walking.will be recorded using a Delsys Trigno system.
timeFrame: 2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
Other outcomes:
Locations:
city: Quebec City
country: Canada
facility: Laval University
state: Quebec
Study officials:
affiliation: Laval University
name: François Routhier, PhD
role: PRINCIPAL_INVESTIGATOR
References: