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NCT Number: NCT05644522

Nomad P-KAFO Study

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

Recruiting

Interested in participating?

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Key information

Conditions

Cerebrovascular Accident Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Infections Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Enterovirus Infections Genetic Diseases, Inborn Immune System Diseases Infections Multiple Sclerosis Muscular Diseases Muscular Disorders, Atrophic Muscular Dystrophies Muscular Dystrophy Musculoskeletal Diseases Myelitis Nervous System Diseases Neurodegenerative Diseases Neuroinflammatory Diseases Neurologic Manifestations Neuromuscular Diseases Paralysis Pathological Conditions, Signs and Symptoms Picornaviridae Infections Poliomyelitis Post-Polio Syndrome Postpoliomyelitis Syndrome RNA Virus Infections Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Stroke Trauma, Nervous System Vascular Diseases Virus Diseases Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Arun Jayaraman, PhD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

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

Device

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.

Primary outcomes

  1. Change in 10 Meter Walk Test speed

    Time frame: Baseline, Post 3-month home trials with each device

    A test to measure the change of speed of both self selected and fastest walking speeds

Secondary outcomes

  1. Six Minute Walk Test

    Time frame: Baseline, Post 3-month home trials with each device

    A test to measure how much distance is traveled over the course of 6 minutes.

  2. Berg Balance Test

    Time frame: Baseline, Post 3-month home trials with each device

    A test of standing balance

  3. Functional Gait Assessment

    Time frame: Baseline, Post 3-month home trials with each device

    A test of postural stability during walking tasks

  4. Hill Assessment Index

    Time frame: Baseline, Post 3-month home trials with each device

    Used to assess different gait patterns during ascent or descent of slopes

  5. Stair Assessment Index

    Time frame: Baseline, Post 3-month home trials with each device

    Used to assess functional abilities during ascent and descent of stairs

  6. Timed Up and Go

    Time frame: Baseline, Post 3-month home trials with each device

    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.

  7. Activities Specific Balance Confidence Scale

    Time frame: Baseline, Post 3-month home trials with each device

    A self-report questionnaire designed to measure fear of falling across 16 items.

  8. Modified Falls Efficacy Scale

    Time frame: Baseline, Post 3-month home trials with each device

    A self-report questionnaire designed to measure fear of falling across 14 items.

  9. Orthotics and Prosthetics User Survey

    Time frame: Baseline, Post 3-month home trials with each device

    A self-report questionnaire designed to evaluate the outcome of orthotic and prosthetic services.

  10. World Health Organization Quality of Life

    Time frame: Baseline, Post 3-month home trials with each device

    A self-report questionnaire that measures an individual's perceived quality of life.

  11. EQ5D-5L

    Time frame: Baseline, Post 3-month home trials with each device

    A self-report questionnaire that measures quality of life with mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

  12. Numeric Pain Rating Scale

    Time frame: Baseline, Post 3-month home trials with each device, and as needed throughout course of study.

    A measure of perceived pain intensity

  13. Borg Rate of Perceived Exertion

    Time frame: Baseline, Post 3-month home trials with each device, and as needed throughout course of study

    A measure of perceived exertion during an activity

  14. Manual Muscle Test

    Time frame: Screening, Baseline, Post 3-month home trials with each device

    A rating of overall gross muscle strength

  15. Range of Motion (both passive and active)

    Time frame: Screening, Baseline, Post 3-month home trials with each device

    A measurement of overall joint mobility of both lower extremities

  16. Six Minute Push Test

    Time frame: Baseline, Post 3-month home trials with each device

    A test to determine distance traveled in a wheelchair with self-propulsion over the course of 6 minutes.

Other outcomes

  1. Cross Walk Blinking Signal Test

    Time frame: Baseline, Post 3-month home trials with each device

    Measuring the time needed to cross a designated street

  2. Community Mobility

    Time frame: During each 3 month home trial with each device.

    Measured by wearing an activity monitor to capture motion / step counts

  3. Self Reported Goals

    Time frame: Baseline, Post 3-month home trials with each device

    Subjects will be interviewed to understand their self-reported functional goals.

Study contacts

Contact information is provided by the study sponsor or research team.

Arun Jayaraman, PhD

CONTACT

[email protected]

312-238-6875

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2022
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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