Active Clinical Studies

Currently a number of clinical studies are being carried out globally with the aim to show the impact on the patients’ health of using the ReWalk System and potential improvement on patients’ quality of life.

Identify Training Strategies for Progressing Exoskeleton Users Towards Everyday Functional Ambulation

Purpose

Many people with spinal cord injury are no longer able to walk and must use wheelchairs for mobility. These individuals experience greater rates of depression and lower quality of life. Many of these individuals express a strong desire to walk again, and report many psychosocial benefits to being eye to eye with peers in social interactions. Additionally, wheelchairs allow only limited community access, creating an additional obstacle to seeking out meaningful social roles in the community. Currently, there is new technology called robotic exoskeletons that would allow people with spinal cord injury to walk. These robotic exoskeletons also allow for curb, ramp, and stair negotiation, which are critical to community access. Current research has examined training with robotic exoskeletons indoors over level surfaces in clinical settings. This study will examine the potential for everyday use, including ramps, stairs, curbs and indoor and outdoor use.

Sponsor:
Rehabilitation Institute of Chicago

Collaborator:
U.S. Department of Education

Locations:

Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
Principal Investigator: Arun Jayaraman, PT, PhD

Status:
Recruiting

Link

Exoskeletal-assisted Walking to Improve Mobility, Bowel Function and Cardio-Metabolic Profiles in Persons With SCI

Purpose

The primary objective of this study is to achieve successful walking skills using exoskeletal walking devices over the course of 36 sessions in 3 months at specific velocities and distances in people with chronic SCI who are wheelchair dependent for community mobility. The secondary objectives are to determine if this amount of exoskeletal walking is effective in improving bowel function and body composition in the same patient population. The exploratory objectives are to address additional questions concerning the retention or non-retention of the positive changes, the effects of the increased physical activity from this intervention on vagal tone, orthostatic tolerance, lipid profile, total testosterone, estradiol levels, and quality of life (QOL).

A Phase III randomized clinical trial (RCT) will be performed using a crossover design and employing an exoskeletal-assisted walking intervention. The experimental arm will be compared to a usual activities (UA) arm, as the control, in 64 persons with chronic SCI (>6 month post injury) who are wheelchair-dependent for outdoor mobility in the community. The WALK arm will consist of supervised exoskeletal-assisted walking training, three sessions per week (4-6 h/week) for 36 sessions for their second 12-week period. The UA arm will consist of identification of usual activities for each participant, encouragement to continue with these activities and attention by study team members throughout the 12-week UA arm. These activities will be recorded in a weekly log. The investigators hypotheses are that 1) this exoskeletal intervention will be successful in training ambulatory skills in this patient population, 2) the exoskeletal intervention will be better than a control group in improving body composition, bowel function, metabolic parameters and quality of life in the same population.

Sponsor:
James J. Peters Veterans Affairs Medical Center

Locations:

University of Maryland Rehabilitation and Orthopaedic Institute (UMROI)
Baltimore, Maryland, United States, 21201
Principal Investigator: Peter Gorman, MD

 

Kessler Foundation Research Center (KFRC)
West Orange, New Jersey, United States, 07052
Principal Investigator: Gail F. Forrest, PhD

 

James J Peteres VA Medical Center
Bronx, New York, United States, 10468
Principal Investigator: Ann M Spungen, EdD

Status:
Recruiting

Link

Exoskeletons for spinal cord injury (SCI): an open, longitudinal, prospective, nonrandomized, self-controlled feasibility study to investigate the effect of the Rewalk™ device on mobility outcomes in patients with chronic SCI

Purpose

In this study, 10 volunteer participants with chronic spinal cord injury will undergo a 10-week training schedule for ambulation with the ReWalk™ device. The ReWalk™ consists of a lightweight brace-support suit containing motors at the hip and knee joints, rechargeable batteries and a computerized control system carried in a backpack. ReWalk™ users control their ambulation through subtle changes in centre of gravity and upper-body movements. Before, during and after training sessions the volunteers will perform standardised assessments and complete questionnaires to assess the functional and psychological effects of the exoskeleton. Functional outcomes primarily focus on ambulation outcomes and psychological outcomes primarily focus on predisposition and perceptions of disability. The outcomes of this pilot study will assist the investigators in the preparations of randomised controlled trail for assessing the efficacy of the ReWalk™ device in a neurorehabilitation setting.

Sponsor:
Buckinghamshire Healthcare NHS Trust

Locations:

National Spinal Injuries Centre, Stoke Mandeville Hospital
Aylesbury, Buckinghamshire, United Kingdom, HP21 8AL
Principal Investigator: Joost J. van Middendorp, MD, PhD

Link

Restoring Walking With a Powered Exoskeleton After Spinal Cord Injury

Purpose

Powered exoskeletons have emerged recently, promising to offer walking to individuals with severe spinal cord injury who are unable to walk. We will use the ReWalk exoskeleton to train walking in individuals with chronic, severe spinal cord injury. We will determine the characteristics of individuals who most benefit from such training, and identify the neuroplasticity induced by the training. We will further determine the feasibility of the ReWalk for home and community ambulation.

Sponsor:
University of Alberta

Locations:

University of Alberta
Edmonton, Alberta, Canada, T6G 2
Principal Investigator: Jaynie Yang, PhD

Status:
Recruiting

Link

The ReWalk Exoskeletal Walking System for Persons With Paraplegia

Purpose

It is well appreciated that an extreme sedentary lifestyle from paralysis, contributes to many secondary medical problems such as diabetes and insulin resistance, obesity, constipation, poor blood pressure regulation, cardiovascular disease, reduced quality of life, and more. The ReWalk-I exoskeleton walking device permits investigation of the potential benefits of frequent upright posture and walking on many of the secondary consequences of spinal cord injury. The researchers are investigating the ability of persons with paraplegia to learn to stand and walk with the ReWalk-I and the effects of being upright and walking on several of these secondary medical consequences of spinal cord injury

Sponsor:
James J. Peters Veterans Affairs Medical Center

Locations:

James J. Peters Veterans Affairs Medical Center; Center of Excellence for the Major Consequences of SCI
Bronx, New York, United States, 10468
Principal Investigator: Ann M Spungen, EdD

Link

Home/Work, Community Mobility Skills in the ReWalk Exoskeleton in Persons With SCI

Purpose

The overall goal of this project is to determine if non-ambulatory persons with spinal cord injury (SCI) who have already participated in at least 20 sessions of ReWalk training can be further trained to achieve more advanced skills for use in the home or work place environments and outdoor community mobility skills in the ReWalk exoskeleton.

Sponsor:
James J. Peters Veterans Affairs Medical Center

Locations:

James J. Peters Veterans Affairs Medical Center; Center of Excellence for the Major Consequences of SCI
Bronx, New York, United States, 10468
Principal Investigator: Ann M Spungen, EdD

Status:
Recruiting

Link

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