Recruiting

Nomad P-KAFO

Sponsor:

Shirley Ryan AbilityLab

Code:

NCT05644522

Conditions

Cerebrovascular Accident

Post-polio Syndrome

Spinal Cord Injuries

Multiple Sclerosis

Muscular Dystrophy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Study ID

NCT05644522

Start date

Mar 1, 2024

Status verified date

May, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Change in 10 Meter Walk Test speed [ Time Frame: Baseline, Post 3-month home trials with each device ]

Central Contacts and Locations

Central contacts

Arun Jayaraman, PhD

312-238-6875ajayaraman@sralab.org

Locations

Shirley Ryan AbilityLab

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Arun Jayaraman, PhD

ajayaraman@sralab.org

More Information

Sponsor

Shirley Ryan AbilityLab

Last update posted

May 11, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Shirley Ryan AbilityLab on 2026-05-11.