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Evaluating Mobility Interventions in the Real World

NCT04275973 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-19

Study results available
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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

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

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • Peter G Adamczyk, Ph.D. · University of Wisconsin, Madison

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-09-03
Primary Completion
2024-08-01
Completion
2024-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04275973 on ClinicalTrials.gov