Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice

Incomplete Spinal Cord Injury Clinical Trial

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?

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04568928
• Other study ID #: 2020-2002
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 10, 2020
• Est. completion date: August 2023

Study information

• Verified date: August 2022
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Incomplete Spinal Cord Injury
• Spinal Cord Injuries

Intervention

Device:
• OLTP/PE + FES
12 sessions OLTP/PE + FES

Locations

Country	Name	City	State
Canada	Laval University	Quebec City	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Praxis Spinal Cord Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Modified Six Minute Walk Test (6MWT)	A walking endurance test that measures the longest distance covered continuously during a maximum of six minutes.	2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
Primary	Change in 10 meter Walk Test (10mWT)	Measures preferred and maximal walking speeds over 10 meters	2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
Primary	Change in Modified Timed Up and Go test (TUG)	A functional test that assesses sit-to-stand transfers, balance and mobility	2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
Primary	Change in Walking Index for Spinal Cord Injury (WISCI-II)	functional walking capacity scale that describes the amount of physical assistance, braces or devices required to walk 10 meters	2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
Secondary	Change in Brief pain inventory questionnaire	Intensity of pain	2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
Secondary	Change in Spinal Cord Injury Secondary Conditions scale (SCI-SCS)	This scale specifically targets secondary conditions associated with SCI that directly and indirectly impact health and physical functioning. The rating scale uses a 4-point ordinal scale ranging from 0 (not experienced/insignificant problem never limiting activity) to 3 (significant/chronic problem). Total scores range from 0 to 48. Higher scores indicate greater overall problems with secondary conditions	2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
Secondary	Change in the Modified Ashworth Scale (MAS)	A measure of lower limb spasticity. Scores range from 0 to 4. Higher scores indicate greater spasticity.; scale.	2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)
Secondary	Change in electromyographic (EMG) activity of the tibialis anterior, triceps surae, quadriceps, hamstrings muscles during walking.will be recorded using a Delsys Trigno system.	Muscle activation patterns (i.e., amplitude, timing) and muscle fatigue (reduction in the median frequency of the EMG power spectrum) will be documented.	2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)