NCT05644522NARecruiting

Nomad P-KAFO Study

Shirley Ryan AbilityLab

Start Date

3/1/2024

Completion Date

12/1/2027

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

Eligibility Criteria

Age Range: 18 years to 89 years

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.)

Interventions

DEVICE

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

Interested in This Trial?

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Conditions

Cerebrovascular AccidentPost-polio SyndromeSpinal Cord InjuriesMultiple SclerosisMuscular DystrophyParalysis

Locations

Shirley Ryan AbilityLab

Chicago, Illinois 60611

United States