Nomad P-KAFO Study

NCT05644522 | Recruiting

• 1 other identifier: STU00217395
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Six Minute Walk Test

  Baseline, Post 3-month home trials with each device

• Berg Balance Test

  Baseline, Post 3-month home trials with each device

• Functional Gait Assessment

  Baseline, Post 3-month home trials with each device

• Hill Assessment Index

  Baseline, Post 3-month home trials with each device

• Stair Assessment Index

  Baseline, Post 3-month home trials with each device

Other Outcomes (3)

• Cross Walk Blinking Signal Test

  Baseline, Post 3-month home trials with each device

• Community Mobility

  During each 3 month home trial with each device.

• Self Reported Goals

  Baseline, Post 3-month home trials with each device

Study Arms (2)

Group A

EXPERIMENTAL

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

ACTIVE COMPARATOR

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)

Interventions

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.

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Stroke; Postpoliomyelitis Syndrome; Spinal Cord Injuries; Multiple Sclerosis; Muscular Dystrophies; Paralysis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Poliomyelitis; Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Muscular Disorders, Atrophic; Muscular Diseases; Musculoskeletal Diseases; Spinal Cord Diseases; Neurodegenerative Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases; Trauma, Nervous System; Wounds and Injuries; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Arun Jayaraman, PhD

CONTACT

312-238-6875; ajayaraman@sralab.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 9, 2022
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 6, 2025

Record last verified: 2025-04

Locations

US (1)