In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Power Forward Study: A Cross-Sector, Multisite Clinical Trial of a Powered Knee-Ankle-Foot Orthosis
About this study
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 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.)
Study design
Enrollment target: 36 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-03-01
Estimated completion: 2027-12
Last updated: 2025-04-06
Interventions
Device: Indego Nomad® Powered Knee-Ankle-Foot Orthosis (P-KAFO) (Parker Hannifin Corp., Cleveland, OH)
Primary outcomes
- • Change in 10 Meter Walk Test speed (Baseline, Post 3-month home trials with each device)
Sponsor
Shirley Ryan AbilityLab · other
Contacts & investigators
ContactArun Jayaraman, PhD · contact · ajayaraman@sralab.org · 312-238-6875
All locations (1)
Shirley Ryan AbilityLabRecruiting
Chicago, Illinois, United States