An interventional study of Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH) in Cerebrovascular Accident, Post-polio Syndrome and Spinal Cord Injuries, sponsored by Shirley Ryan AbilityLab. Recruiting at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-05-11.
Sponsored by Shirley Ryan AbilityLab · Not applicable, Interventional, and Treatment
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:
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 36 is below the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Shirley Ryan AbilityLab is the lead sponsor of 180 studies on the registry; 44 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 4 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
Change in 10 Meter Walk Test speed
A test to measure the change of speed of both self selected and fastest walking speeds
Time frame: Baseline, Post 3-month home trials with each device
Six Minute Walk Test
A test to measure how much distance is traveled over the course of 6 minutes.
Time frame: Baseline, Post 3-month home trials with each device
Berg Balance Test
A test of standing balance
Time frame: Baseline, Post 3-month home trials with each device
Functional Gait Assessment
A test of postural stability during walking tasks
Time frame: Baseline, Post 3-month home trials with each device
Hill Assessment Index
Used to assess different gait patterns during ascent or descent of slopes
Time frame: Baseline, Post 3-month home trials with each device
Stair Assessment Index
Used to assess functional abilities during ascent and descent of stairs
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Post 3-month home trials with each device
Numeric Pain Rating Scale
A measure of perceived pain intensity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: Baseline, Post 3-month home trials with each device
Cross Walk Blinking Signal Test
Measuring the time needed to cross a designated street
Time frame: Baseline, Post 3-month home trials with each device
Community Mobility
Measured by wearing an activity monitor to capture motion / step counts
Time frame: During each 3 month home trial with each device.
Self Reported Goals
Subjects will be interviewed to understand their self-reported functional goals.
Time frame: Baseline, Post 3-month home trials with each device
Started Mar 2024 (actual). Primary completion is estimated for Dec 2027, 45 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 45 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.