NCT02943915

The WISE Trial - Walking Improvement for SCI With Exoskeleton

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Ekso Bionics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Community dwelling iSCI participants may improve clinical gait function by engaging in a gait training regimen, where robotic exoskeletons can readily deliver a precise dose and simultaneously reduce the physical stress imposed on therapists using conventional manually assisted stepping practice. Exoskeleton training is predicted to improve function in participants receiving usual care, but not superior to intensity-matched manual training. The rationale to implement exoskeleton robotics as preference in gait training is based on precision dosing, over-ground training, and reduced therapist burden for high repetition training. The investigators aim to demonstrate that Ekso exoskeleton training can significantly improve gait speed in stable chronic, community-dwelling incomplete SCI (iSCI) participants. The objectives of this study are the following: A. Primary Objective: To demonstrate that a 12 week robotic gait training regimen can lead to a clinically meaningful improvement in independent gait speed on the 10 Meter Walk Test (10MWT) in community dwelling participants with chronic iSCI. B. Secondary Objectives: 1. To examine the economic factors such as number of physical therapists/staff required during training. 2. To analyze the physical burden on therapists assisting and supervising during training. 3. To study the influence of factors that may modify the gait recovery in the chronic incomplete SCI population (demographic, clinical, functional, psychological, balance, etc.).

Conditions

• Injuries, Spinal Cord

Interventions

Type	Name	Description
DEVICE	Ekso GT Rehabilitation Therapy	Walking Improvement for Spinal Cord Injuries with Exoskeleton
DEVICE	Body Weight Supported (BWS) Treadmill Training	Standard gait training using BWS PT and overground training

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-09-10
• Completion: 2019-09-10
• First posted: 2016-10-25
• Last updated: 2023-10-31
• Results posted: 2023-10-31

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study