Actively Recruiting
Power Forward Study: A Multisite Clinical Trial Comparing the Nomad Powered Knee-Ankle-Foot Orthosis to Traditional Braces in Adults with Walking Impairments
Led by Shirley Ryan AbilityLab · Updated on 2026-05-11
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of the Nomad powered Knee-Ankle-Foot Orthosis (P-KAFO) in adults who have had musculoskeletal or neurological injuries affecting their ability to walk. The trial aims to measure how this device improves mobility, balance, frequency of falls, and quality of life compared to participants' own braces over a three-month period of daily home and community use. This study is a randomized clinical trial sponsored by Shirley Ryan AbilityLab. Participants are divided into two groups. Group A starts with the Nomad device, receiving fitting and training, followed by a three-month home trial, then outcomes testing. They then switch to their own traditional assistive device for another three-month home trial and testing. Group B follows the reverse order, starting with their own device and then moving to the Nomad. The Nomad is a microprocessor-controlled orthosis with powered assistance for knee movement and stance support. During the study, participants wear a sensor to record their daily activities and mobility. They will perform various mobility tests and functional assessments at baseline and after each three-month trial period with each device. Outcome measures include walking speed, balance tests, gait assessments, quality of life surveys, pain and exertion ratings, muscle strength, and range of motion. The trial lasts for about six months per participant, with careful monitoring of their progress and device use.
CONDITIONS
Brief Title
Nomad P-KAFO Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Regular and compliant use of a unilateral or bilateral knee-ankle-foot orthosis (KAFO), stance control orthosis (SCO), or other passive KAFOs for impairments caused by neurological, neuromuscular, orthopedic disease, or trauma
- Cognitive ability to understand and follow the study protocol and willingness to provide informed consent
- Willingness to wear and charge an activity monitor during the three-month home trials
You will not qualify if you...
- Flexion contracture in the knee and/or hip joint greater than 15 degrees
- Non-correctable knee varus or valgus deformity greater than 15 degrees
- Severe spasticity
- Inability to stabilize the trunk with or without assistive devices such as crutches or canes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 6 months total (two 3-month home trials)
Participants receive fitting and training with the Nomad Powered Knee-Ankle-Foot Orthosis or their own Traditional Assistive Device, followed by a 3-month home trial and outcomes testing. Participants then cross over to the other device, repeat training, a 3-month home trial, and outcomes testing.
Multiple training visits followed by outcomes testing visits after each 3-month home trial
Trial Site Locations
Total: 1 location
1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
A
Arun Jayaraman, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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