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Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice

Primary Purpose

Incomplete Spinal Cord Injury

Status

Enrolling by invitation

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

OLTP/PE + FES

About this trial

This is an interventional treatment trial for Incomplete Spinal Cord Injury focused on measuring Exoskeleton, locomotor training, FES, SCI

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Laval University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OLTP/PE+FES

Arm Description

3-5 familiarization sessions + 12 training sessions (3 blocks of 4 training sessions; 60-90 min each session, 2-3 sessions per week) of an overground locomotor training program using a powered exoskeleton combined with functional electrical stimulation (OLTP/PE+FES). The training sessions are divided into 3 blocks. Each block will take place over a period of approximately 2 weeks (2-3 sessions/week) and will consist of 3 training sessions with exoskeleton combined with FES and a fourth session with exoskeleton alone, without FES. For each participant, FES intensity will be set for each muscle in order to elicit a palpable muscle contraction. FES timing and duration is already built into the device. For each participant, specific level of assistance for each hip and knee, and gait parameters will be set and adjusted during a familiarization period with the PE. Level of PE assistance will then be adjusted weekly to ensure training progression.

Outcomes

Primary Outcome Measures

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.

Change in 10 meter Walk Test (10mWT)

Measures preferred and maximal walking speeds over 10 meters

Change in Modified Timed Up and Go test (TUG)

A functional test that assesses sit-to-stand transfers, balance and mobility

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

Secondary Outcome Measures

Change in Brief pain inventory questionnaire

Intensity of pain

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

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.

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.

Full Information

NCT ID

NCT04568928

First Posted

September 11, 2020

Last Updated

August 22, 2022

Sponsor

Laval University

Collaborators

Praxis Spinal Cord Institute

1. Study Identification

Unique Protocol Identification Number

NCT04568928

Brief Title

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

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

December 10, 2020 (Actual)

Primary Completion Date

August 2023 (Anticipated)

Study Completion Date

August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Laval University

Collaborators

Praxis Spinal Cord Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Incomplete Spinal Cord Injury

Keywords

Exoskeleton, locomotor training, FES, SCI

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

OLTP/PE+FES

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

OLTP/PE + FES

Intervention Description

12 sessions OLTP/PE + FES

Primary Outcome Measure Information:

Title

Change in Modified Six Minute Walk Test (6MWT)

Description

A walking endurance test that measures the longest distance covered continuously during a maximum of six minutes.

Time Frame

2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

Title

Change in 10 meter Walk Test (10mWT)

Description

Measures preferred and maximal walking speeds over 10 meters

Time Frame

2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

Title

Change in Modified Timed Up and Go test (TUG)

Description

A functional test that assesses sit-to-stand transfers, balance and mobility

Time Frame

2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

Title

Change in Walking Index for Spinal Cord Injury (WISCI-II)

Description

functional walking capacity scale that describes the amount of physical assistance, braces or devices required to walk 10 meters

Time Frame

2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

Secondary Outcome Measure Information:

Title

Change in Brief pain inventory questionnaire

Description

Intensity of pain

Time Frame

2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

Title

Change in Spinal Cord Injury Secondary Conditions scale (SCI-SCS)

Description

Time Frame

2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

Title

Change in the Modified Ashworth Scale (MAS)

Description

A measure of lower limb spasticity. Scores range from 0 to 4. Higher scores indicate greater spasticity. scale.

Time Frame

2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

Title

Change in electromyographic (EMG) activity of the tibialis anterior, triceps surae, quadriceps, hamstrings muscles during walking.will be recorded using a Delsys Trigno system.

Description

Muscle activation patterns (i.e., amplitude, timing) and muscle fatigue (reduction in the median frequency of the EMG power spectrum) will be documented.

Time Frame

2 assessment timepoints: at baseline, at the end of the intervention (1 to 2 weeks later)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

François Routhier, PhD

Organizational Affiliation

Laval University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Laval University

City

Quebec City

State/Province

Quebec

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice

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