Nomad P-KAFO Study
Power Forward Study: A Cross-Sector, Multisite Clinical Trial of a Powered Knee-Ankle-Foot Orthosis
What it found
No result yet.
What was tested
Treatment tested
- Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)
What it measured
Main measures
Change in 10 Meter Walk Test speed
Baseline, Post 3-month home trials with each device
Walking and mobility
Other measures (16)
Six Minute Walk Test
Baseline, Post 3-month home trials with each device
Walking and mobilityBerg Balance Test
Baseline, Post 3-month home trials with each device
Walking and mobilityFunctional Gait Assessment
Baseline, Post 3-month home trials with each device
Walking and mobilityHill Assessment Index
Baseline, Post 3-month home trials with each device
Walking and mobilityStair Assessment Index
Baseline, Post 3-month home trials with each device
Timed Up and Go
Baseline, Post 3-month home trials with each device
Walking and mobilityActivities Specific Balance Confidence Scale
Baseline, Post 3-month home trials with each device
Walking and mobilityModified Falls Efficacy Scale
Baseline, Post 3-month home trials with each device
Walking and mobilityOrthotics and Prosthetics User Survey
Baseline, Post 3-month home trials with each device
World Health Organization Quality of Life
Baseline, Post 3-month home trials with each device
Quality of life (reported by participants)
Who could take part
MS (type not specified) · 18 to 89
Show the full 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 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.)
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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
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History
Started
Mar 2024
Main results due
Dec 2027
Finished
Dec 2027