Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice

NCT04568928 | Unknown

• 1 other identifier: 2020-2002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Incomplete Spinal Cord Injury

Keywords

Exoskeleton, locomotor training, FES, SCI

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (4)

• Change in Brief pain inventory questionnaire

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

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

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

• Change in the Modified Ashworth Scale (MAS)

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

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

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

Study Arms (1)

OLTP/PE+FES

EXPERIMENTAL

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.

Device: OLTP/PE + FES

Interventions

OLTP/PE + FES DEVICE

12 sessions OLTP/PE + FES

OLTP/PE+FES

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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
• Pregnancy;

Sponsors & Collaborators

• Laval University: lead
• Praxis Spinal Cord Institute: collaborator

Study Sites (1)

Laval University

Québec, Quebec, Canada

Location

Study Officials

• François Routhier, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor/ Researcher

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 29, 2020
• Study Start: December 10, 2020
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 24, 2022

Record last verified: 2022-08

Locations

CA (1)