The WISE Trial - Walking Improvement for SCI With Exoskeleton

Completed · Not applicable

Conditions studied: Injuries, Spinal Cord

In brief

A randomized, controlled trial comparing exoskeleton gait training with standard gait training or no gait training in community-dwelling participants with chronic incomplete spinal cord injury

Key facts

Study ID

NCT02943915

Run by

Ekso Bionics

People needed

45

Starts

2016-09-01

Expected to finish

2019-09-10

Last updated by the study team

2023-10-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Motor incomplete paraplegia or tetraplegia
• Neurological level of injury (NLI) C1- approximately T10 (inclusive, for upper motor neuron injuries only), as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
• Sufficient diaphragmatic strength such that respiration is not compromised with exercise.
• Sufficient upper extremity strength to use a front wheeled walker either by manual muscle testing (minimum triceps strength bilaterally of 3/5, shoulder abduction/adduction and flexion/extension 4/5)
• AIS-C SCI \& AIS-D SCI, as determined by the International Standards for Neurological Classification of SCI (ISNCSCI)
• Ambulates at <0.44 meters/second with or without physical assistance and assistance device
• WISCI ≥ 1
• 18 - 75 yrs, inclusive
• No current or history of other neurological conditions
• Screened and cleared by a physician
• Involved in standing program or must be able to tolerate at least 15 min upright
• Weigh 220 pounds (100kg) or less
• Be able to fit into the Ekso device
• Approximately between 5'0" and 6'4" tall
• Standing hip width of approximately 18" or less
• Have near normal range of motion in hips, knees and ankles

You may not qualify if…

• AIS-A SCI or AIS-B SCI
• Lower motor neuron injuries, as shown by absent reflexes during bilateral quadriceps and Achilles tendon taps
• < 3 months since previous intensive gait training regimen
• Already walking at self-selected ambulation speeds of at least 0.44 meter/second with or without assistance
• Currently involved in another intervention study
• Concurrent neurological disease
• Hip flexion contracture greater than \~17°
• Knee flexion contracture greater than 12°
• Unable to achieve neutral ankle dorsiflexion with passive stretch (neutral with max 12° knee flexion)
• Leg length discrepancy
• Greater than 0.5" for upper leg
• Greater than 0.75" for lower leg
• Spinal instability
• Unresolved deep vein thrombosis
• Uncontrolled autonomic dysreflexia
• Severe muscular or skeletal pain
• Spasticity that prevents joint motion (severe stiffness or rigidity,) where both legs have a Modified Ashworth Score (MAS) score of 3 or higher for half or more of their proximal lower extremity muscles; proximal muscles include hip flexors/extensors/adductors and knee flexors/extensors.
• Open skin ulcerations on buttocks or other body surfaces in contact with exoskeleton or harness
• Pregnancy
• Cognitive impairments - unable to follow 2 steps commands and communicate for pain or to stop session
• Shoulder extension Range of Motion (ROM) < 50° excludes crutches during sit to stand or vice versa. (Walking with crutches permitted.)
• Participant requires the assistance of more than one therapist to transfer safely.
• Uncontrolled or severe orthostatic hypotension that limits standing tolerance; defined as sustained, symptomatic drops in systolic and diastolic blood pressure when moving from sitting to standing
• Active heterotrophic ossification (HO), hip dysplasia or hip/knee axis abnormalities
• Colostomy

Where it is running

• Barrow Neurological Institute at St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• Gaylord Hospital — Wallingford, Connecticut, United States
• Shirley Ryan AbilityLab — Chicago, Illinois, United States
• Marianjoy Rehabilitation Hospital — Wheaton, Illinois, United States
• Kennedy Kruger Institute — Baltimore, Maryland, United States
• Rehabilitation Institute of Michigan — Detroit, Michigan, United States
• Courage Kenny Research Center — Minneapolis, Minnesota, United States
• Kessler Foundation — West Orange, New Jersey, United States
• Burke Medical Research Institute — White Plains, New York, United States
• TIRR Memorial Hermann Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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