Power Forward Study A Multisite Clinical Trial Comparing the Nomad Powered Knee-Ankle-Foot Orthosis to Traditional Braces in Adults with Walking Impairments

What this Trial Is About

Researchers are evaluating the impact of the Nomad powered Knee-Ankle-Foot Orthosis P-KAFO in adults who have had musculoskeletal or neurological injuries affecting their ability to walk. The trial aims to measure how this device improves mobility, balance, frequency of falls, and quality of life compared to participants own braces over a three-month period of daily home and community use. This study is a randomized clinical trial sponsored by Shirley Ryan AbilityLab. Participants are divided into two groups. Group A starts with the Nomad device, receiving fitting and training, followed by a three-month home trial, then outcomes testing. They then switch to their own traditional assistive device for another three-month home trial and testing. Group B follows the reverse order, starting with their own device and then moving to the Nomad. The Nomad is a microprocessor-controlled orthosis with powered assistance for knee movement and stance support. During the study, participants wear a sensor to record their daily activities and mobility. They will perform various mobility tests and functional assessments at baseline and after each three-month trial period with each device. Outcome measures include walking speed, balance tests, gait assessments, quality of life surveys, pain and exertion ratings, muscle strength, and range of motion. The trial lasts for about six months per participant, with careful monitoring of their progress and device use.

Nomad P-KAFO Study