About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Regular and compliant use of a unilateral or bilateral KAFO or SCO or other passive KAFOs for impairment due to neurological or neuromuscular disease, orthopedic disease, or trauma
Cognitive ability to understand and follow the study protocol; willingness to provide informed consent
Willing to wear and charge an activity monitor for three-months home trials.
Disqualifiers
Flexion contracture in the knee and/or hip joint in excess of 15 degrees
Non-correctable knee varus/valgus in excess of 15 degrees
Severe spasticity
Inability to stabilize the trunk with or without assistive devices (crutches, canes, etc.)
Trial design
Crossover
Treatments tested in this trial
Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)
DeviceThe 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.
Treatment groups
Trial outcomes
Primary outcomes
Change in 10 Meter Walk Test speed
A test to measure the change of speed of both self selected and fastest walking speeds
Secondary outcomes
Six Minute Walk Test
A test to measure how much distance is traveled over the course of 6 minutes.
Berg Balance Test
A test of standing balance
Functional Gait Assessment
A test of postural stability during walking tasks
Hill Assessment Index
Used to assess different gait patterns during ascent or descent of slopes
Other outcomes
Cross Walk Blinking Signal Test
Measuring the time needed to cross a designated street
Community Mobility
Measured by wearing an activity monitor to capture motion / step counts
Self Reported Goals
Subjects will be interviewed to understand their self-reported functional goals.
Sponsors and contacts
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