Powered Exoskeleton Combined With Functional Electrical Stimulation in Clinical Practice

NCT ID: NCT04568928

Last Updated: 2022-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-10
• Study Completion Date: 2023-08-31

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.

Conditions

Incomplete Spinal Cord Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OLTP/PE+FES

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.

Group Type: EXPERIMENTAL

OLTP/PE + FES

Intervention Type: DEVICE

12 sessions OLTP/PE + FES

Interventions

OLTP/PE + FES

12 sessions OLTP/PE + FES

Intervention Type: DEVICE

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

• Pregnancy;
• Presence of a malignant tumor
• Deep vein thrombosis
• Hemorrhagic condition
• Infection or osteomyelitis
• Presence of weakened/damaged skin
• Circulatory disorders
• Epilepsy
• Electronic implant

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Praxis Spinal Cord Institute

OTHER

Sponsor Role: collaborator

Laval University

OTHER

Sponsor Role: lead

Responsible Party

François Routhier

Full Professor/ Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

François Routhier, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

Laval University

Québec, Quebec, Canada

Countries

Canada

Other Identifiers

2020-2002

Identifier Type: -

Identifier Source: org_study_id