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NCT05644522
Nomad P-KAFO Study
Conditions: Cerebrovascular Accident, Post-polio Syndrome, Spinal Cord Injuries, Multiple Sclerosis, Muscular Dystrophy, Paralysis
Sex: All
Ages: 18 Years – 89 Years
Phase: NA
Enrollment: 36
Sponsor: Shirley Ryan AbilityLab
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
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 traumaCognitive ability to understand and follow the study protocol; willingness to provide informed consentWilling 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 degreesNon-correctable knee varus/valgus in excess of 15 degreesSevere spasticityInability to stabilize the trunk with or without assistive devices (crutches, canes, etc.)
Source: ClinicalTrials.gov (NCT05644522). StuddyBuddy aggregates publicly available trial information.