NCT04275973

Evaluating Mobility Interventions in the Real World

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is intended to test the comparative biomechanical benefits of different lower-limb prostheses and orthoses using data collected over extended periods of everyday life using wearable sensors. Investigators seek to improve physical health, functional activity level, independence, workforce participation, and mental health in participants with lower limb amputation and other lower-limb impairments. Investigators seek to study the similarities and differences in participants' movement using prostheses and orthoses with different technological features or designs. Study team also seek to develop technologies that enhance the methods for using wearable sensor technology to perform this type of study. Participants with lower-limb amputation, participants who use lower limb orthoses, and participants with drop-foot (including a specific group with Multiple Sclerosis).

Conditions

• Lower Limb Amputation
• Drop Foot

Interventions

Type	Name	Description
DEVICE	Lower limb prostheses	Standard commercially available prostheses for participants with lower-limb amputation. Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR, Agilix) feet and low-profile foot (LP, Pacifica LP), ESR feet with mobilized ankles such as passive hydraulic ankles (PHA, Kinterra), and ESR feet with microprocessor-controlled ankles (MPA, Kinnex).
DEVICE	Orthoses for Drop-foot	Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses. Sprystep for the caAFO, Bioness L300 Go for the FES

Timeline

• Start date: 2021-09-03
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2020-02-19
• Last updated: 2025-12-19
• Results posted: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study