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RecruitingNot ApplicableNCT05644522

Nomad P-KAFO Study

Power Forward Study: A Cross-Sector, Multisite Clinical Trial of a Powered Knee-Ankle-Foot Orthosis

Sponsor

Shirley Ryan AbilityLab

Enrollment

36 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple SclerosisSpinal Cord InjuriesCerebrovascular AccidentPost-polio SyndromeMuscular DystrophyParalysis

Summary

The goal of this clinical trial is to evaluate the impact of using the Nomad powered KAFO in people who have had a musculoskeletal or neurological injury that has affected their ability to walk. The main questions it aims to answer are to quantify the effectiveness of the Nomad in improving mobility, balance, frequency of falls, and quality of life in individuals with lower-extremity impairments compared to their own brace, over three months of daily home and community use. Participants will: * Wear a sensor that records everyday activities and mobility. * Perform measures of mobility and different activities of participation using their own brace. * Perform measures of mobility and different activities of participation using the Nomad powered KAFO

Eligibility

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a motorized knee brace (called the Nomad P-KAFO — a powered knee-ankle-foot orthosis) to help people who rely on a leg brace due to neurological, neuromuscular, or orthopedic conditions walk more easily at home and in daily life. **You may be eligible if...** - You regularly use a knee-ankle-foot orthosis (KAFO), stance control orthosis (SCO), or similar passive brace for a qualifying condition - You have the cognitive ability to understand and follow the study - You are willing to wear an activity monitor and charge the device over a 3-month home trial **You may NOT be eligible if...** - You have a knee or hip joint that is bent more than 15 degrees and cannot be straightened - You have severe muscle stiffness (spasticity) - You cannot balance your trunk even with assistive devices like crutches or a cane - Your knee bows inward or outward by more than 15 degrees and cannot be corrected Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIndego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)

The Nomad is a microprocessor-controlled knee-ankle-foot orthosis P-KAFO that incorporates a motor for powered movement assistance and an electronic brake for stance support. The system provides active assistance for knee flexion and extension during the swing phase of gait, reliable stance phase locking at any knee angle, and reliable unlocking without requiring user-generated knee or hip extension torque.

Locations(1)

Shirley Ryan AbilityLab

Chicago, Illinois, United States

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NCT05644522

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