Nomad P-KAFO Study

Study Overview
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Brief Summary
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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

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

Conditions
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Cerebrovascular Accident, Post-polio Syndrome, Spinal Cord Injuries, Multiple Sclerosis, Muscular Dystrophy, Paralysis

Intervention / Treatment
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* Device: Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Group A receives the intervention Nomad KAFO first; fitting & training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing. Group A then will cross over and train with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing. | Device: Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)<br>* 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.<br>|
| Active Comparator: Group B<br>Group B receives training in their own Traditional Assistive Device first; training will occur with their own Traditional Assistive Device and will then use their own device for a 3 month home trial, followed by outcomes testing. Group B then will cross over and receive the intervention Nomad KAFO; fitting & training will occur with the intervention and will then be used for a 3 month home trial, followed by outcomes testing. | Device: Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 10 Meter Walk Test speed | A test to measure the change of speed of both self selected and fastest walking speeds | Baseline, Post 3-month home trials with each device | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six Minute Walk Test | A test to measure how much distance is traveled over the course of 6 minutes. | Baseline, Post 3-month home trials with each device | 
| Berg Balance Test | A test of standing balance | Baseline, Post 3-month home trials with each device | 
| Functional Gait Assessment | A test of postural stability during walking tasks | Baseline, Post 3-month home trials with each device | 
| Hill Assessment Index | Used to assess different gait patterns during ascent or descent of slopes | Baseline, Post 3-month home trials with each device | 
| Stair Assessment Index | Used to assess functional abilities during ascent and descent of stairs | Baseline, Post 3-month home trials with each device | 
| Timed Up and Go | A functional mobility test to measure how long it takes to rise from a chair, walk 3 meters, turn around, and return back to a sitting position in the chair. | Baseline, Post 3-month home trials with each device | 
| Activities Specific Balance Confidence Scale | A self-report questionnaire designed to measure fear of falling across 16 items. | Baseline, Post 3-month home trials with each device | 
| Modified Falls Efficacy Scale | A self-report questionnaire designed to measure fear of falling across 14 items. | Baseline, Post 3-month home trials with each device | 
| Orthotics and Prosthetics User Survey | A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services. | Baseline, Post 3-month home trials with each device | 
| World Health Organization Quality of Life | A self-report questionnaire that measures an individual's perceived quality of life. | Baseline, Post 3-month home trials with each device | 
| EQ5D-5L | A self-report questionnaire that measures quality of life with mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | Baseline, Post 3-month home trials with each device | 
| Numeric Pain Rating Scale | A measure of perceived pain intensity | Baseline, Post 3-month home trials with each device, and as needed throughout course of study. | 
| Borg Rate of Perceived Exertion | A measure of perceived exertion during an activity | Baseline, Post 3-month home trials with each device, and as needed throughout course of study | 
| Manual Muscle Test | A rating of overall gross muscle strength | Screening, Baseline, Post 3-month home trials with each device | 
| Range of Motion (both passive and active) | A measurement of overall joint mobility of both lower extremities | Screening, Baseline, Post 3-month home trials with each device | 
| Six Minute Push Test | A test to determine distance traveled in a wheelchair with self-propulsion over the course of 6 minutes. | Baseline, Post 3-month home trials with each device |