Evaluating the Nomad powered KAFO for improving mobility in individuals with lower-extremity impairments
Power Forward Study: A Cross-Sector, Multisite Clinical Trial of a Powered Knee-Ankle-Foot Orthosis
This study is testing if a new powered brace can help people with leg injuries move better and feel more balanced compared to their regular braces.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | Shirley Ryan AbilityLab Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05644522 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of the Nomad powered knee-ankle-foot orthosis (P-KAFO) in enhancing mobility, balance, and quality of life for individuals who have experienced musculoskeletal or neurological injuries. Participants will use both their own brace and the Nomad device over a three-month period, with their activities monitored through sensors. The study will compare the outcomes of using the Nomad P-KAFO against the participants' existing braces to determine improvements in mobility and reduction in falls.
Who should consider this trial
Good fit: Ideal candidates include individuals with neurological or neuromuscular diseases who regularly use a KAFO or similar device.
Not a fit: Patients with severe joint contractures, spasticity, or those unable to stabilize their trunk may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance mobility and quality of life for patients with lower-extremity impairments.
How similar studies have performed: While the specific Nomad P-KAFO approach may be novel, similar studies evaluating powered orthoses have shown promising results in improving mobility.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Chicago, Illinois
- Shirley Ryan AbilityLab — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Arun Jayaraman, PhD
- Email: ajayaraman@sralab.org
- Phone: 312-238-6875
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.