Nomad P-KAFO Study

Shirley Ryan AbilityLab

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05644522

STU00217395

Details and patient eligibility

About

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

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Group A

Experimental group

Description:

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.

Treatment:

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

Group B

Active Comparator group

Description:

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.

Treatment:

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