Power Forward Study: A Cross-Sector, Multisite Clinical Trial of a Powered Knee-Ankle-Foot Orthosis
Abstract
Objectives and Rationale: Knee-ankle-foot-orthoses (KAFOs) are commonly prescribed assistive devices used by millions of people who have lower-extremity weakness or paralysis, including wounded Service Members, Veterans, and the civilian population. KAFOs are designed to control instabilities in the knee and lower limb to help enable mobility, but current orthotic options cause users to alter their normal walking patterns because they stop the knee from bending, placing undue stress on the lower limbs and hips. Currently available devices can also be unreliable, especially when walking on uneven terrain such as ramps and stairs. The Nomad is a recently commercialized powered KAFO (P-KAFO) developed by Parker Hannifin. It is the first powered custom orthosis that provides active assistance to the user during walking when the foot leaves the ground (swing) and reliable knee stability when the foot touches back down on the ground (stance). The device is designed to provide power and support specifically when needed, allowing patients to walk in ways they previously could not, and to prevent users from developing abnormal walking patterns that put stress on other joints. Although the Nomad has great potential, it has not yet been extensively evaluated with individuals in a real-world environment. The objective of this proposal is to quantify the real-world impact of the Nomad on KAFO users who have lower extremity weakness that limits their mobility. Our rationale is that a powered orthosis that actively helps users to walk and provides better stability will increase their mobility and make it easier and safer for them to perform other daily activities. In the proposed study, we will compare the benefits of the Nomad with users’ prescribed orthoses. Subjects will use the Nomad or their prescribed device in 3-month home trials, and complete outcome measures and self-reported measures to assess walking performance, pain, device usage, and quality of life before and after the home trial. They will then complete the same procedures with the other device. We will also use wearable sensors, standard clinical measures to track how subjects use the devices at home, and whether the P-KAFO improves their overall functional mobility level. Our subject population will include Veterans and civilians recruited from the Shirley Ryan AbilityLab. Parker Hannifin will provide training and technical support. Who It Will Help and How: This research has the potential to help a great number of people who have extensive lower-limb weakness or paralysis and use a KAFO in their daily lives, including individuals with incomplete spinal cord injury, stroke, multiple sclerosis, post-polio syndrome, and other conditions that affect the central nervous and musculoskeletal system (in total, more than 5.4 million persons in the U.S.). Potential Clinical Applications Benefits and Risks: By evaluating the Nomad P-KAFO in home trials, we will: • Understand whether a P-KAFO has a significant effect on mobility activity, balance, and quality of life in current KAFO users. • Understand how users feel about the P-KAFO, how they use it, and the usability and comfort of this device at home, which could guide clinicians’ prescribing options and facilitate reimbursement for orthotic devices. Projected Timeline: We aim to enroll and complete outcomes testing in 30 participants in 4 years. At the end of this project, we will obtain specific data on activity levels and device usage. In the long term, our team will work toward implementing lessons learned from this project into clinical practice guidelines for KAFO users and for the benefit of military Service Members and Veterans who are either returning to active duty or transitioning to civilian life. We will communicate results in peer-reviewed journal publications, on our websites and social media platforms, and at relevant clinical and engineering symposiums and conferences. How the Proposed Researc
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210834
Entities
People
- Arun Jayaraman
Organizations
- Shirley Ryan AbilityLab
- United States Army