Nomad P-KAFO Study

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

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

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis; Paralysis; Muscular Dystrophy; Spinal Cord Injuries; Cerebrovascular Accident; Post-polio Syndrome
• Intervention / Treatment: Device: Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arun Jayaraman, PhD; Phone Number: 312-238-6875; Email: ajayaraman@sralab.org

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Recruiting
      • Shirley Ryan AbilityLab
      • Contact: Arun Jayaraman, PhD; Email: ajayaraman@sralab.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; 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); 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.
Active Comparator: Group B; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cross Walk Blinking Signal Test	Measuring the time needed to cross a designated street	Baseline, Post 3-month home trials with each device
Community Mobility	Measured by wearing an activity monitor to capture motion / step counts	During each 3 month home trial with each device.
Self Reported Goals	Subjects will be interviewed to understand their self-reported functional goals.	Baseline, Post 3-month home trials with each device

Collaborators and Investigators

• Sponsor: Shirley Ryan AbilityLab

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: November 28, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neuroinflammatory Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Muscular Diseases; Wounds and Injuries; Neuromuscular Diseases; Genetic Diseases, Inborn; Autoimmune Diseases; Immune System Diseases; Infections; RNA Virus Infections; Virus Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Neurodegenerative Diseases; Enterovirus Infections; Picornaviridae Infections; Trauma, Nervous System; Muscular Disorders, Atrophic; Spinal Cord Diseases; Central Nervous System Infections; Myelitis; Poliomyelitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Multiple Sclerosis; Muscular Dystrophies; Spinal Cord Injuries; Paralysis; Postpoliomyelitis Syndrome
• Other Study ID Numbers: STU00217395

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No