Nomad P-KAFO Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-89
SponsorShirley Ryan AbilityLab

About this trial

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

Qualifiers

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.

Disqualifiers

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

Treatments tested in this trial

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

Treatment groups

36 Participants
are divided into 2 treatment groups

Sponsors and collaborators