Evaluating Mobility Interventions in the Real World

NCT04275973 | Completed Results FDA Device

• 5 other identifiers: 2019-0844A196200ENGR/MECHANICAL ENGR/MECH ENGRBA180043Protocol Version 9/21/2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prostheses; Orthoses

Outcome Measures

Primary Outcomes (2)

• Minimum Foot Clearance With Different Prostheses

  Minimum Foot Clearance with different prostheses, participants crossover to each of 4 different conditions at different study visits, data collected up to 12 weeks on study.

  Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

• Minimum Foot Clearance With Different Orthoses

  Minimum Foot Clearance with different orthoses, participants crossover to each of 3 different conditions at different study visits, data collected up to 20 days on study.

  Baseline, 10 days, and 20 days for Orthotic interventions

Secondary Outcomes (12)

• Behavioral Gait Function as Measured From Daily Stride Count

  Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

• Behavioral Gait Function as Measured From Stride Speed During Walking Bouts of Different Durations

  Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

• Prosthetic Limb Users Survey of Mobility Score

  up to 12 weeks

• Change in Movement Quality as Determined by Stride Width: Prosthesis

  Weekly time points for Prosthetic interventions (baseline, 1, 2, 3, and 4 weeks), data collected anytime up to 12 weeks on study

• Change in Movement Quality as Determined by Stride Width: Orthoses

  Baseline, 10 days, and 20 days for Orthotic interventions

Study Arms (2)

Prosthesis user with transtibial or transfemoral amputation

EXPERIMENTAL

Experiments will use 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) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA).

Device: Lower limb prostheses

Orthoses user with drop-foot

EXPERIMENTAL

This arm will consists of participants with drop-foot. A subset of the drop-foot population will be persons with Multiple Sclerosis and currently drop-foot. For participants in this arm, standard commercially-available orthoses or standard-of-care custom orthoses will be used, as well as standard commercially-available electrical stimulation neuro-orthoses.

Device: Orthoses for Drop-foot

Interventions

Lower limb prostheses DEVICE

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).

Also known as: Low-profile foot, Energy-storing foot, Hydraulic ankle, Microprocessor ankle

Prosthesis user with transtibial or transfemoral amputation

Orthoses for Drop-foot DEVICE

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

Also known as: carbon fiber ankle foot orthosis (caAFO), functional electrical stimulation (FES)

Orthoses user with drop-foot

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Target Populations:
• Participants with amputation must have used a prosthesis for more than 6 months, and wear it for at least 8 hours per day.
• Participants must be more than 6 months past their most recent surgery (if any).
• Participants must be free of musculoskeletal and cardiovascular conditions that would limit their ability to safely complete testing.
• Participants should consider themselves in good health; be able to wear their prostheses or orthoses all day long; be able to perform all of their activities of daily living (ADL) with their prostheses or orthoses as appropriate; have a comfortably fitting functional prosthesis (if applicable) that does not cause any skin problems; and have a stable residual limb (or impaired limb).
• Participants may use a narrow-base cane (single point, narrow tripod base, etc.) as an ambulatory aid but not a small-base quad cane or walker.
• Participants must be able to walk with their prostheses or orthoses for 30 minutes (total) and stand for 30 minutes (total), in individual bouts of at least 6 minutes, without becoming fatigued, feeling dizzy, having chest pain or shortness of breath, or experiencing claudication symptoms.
• Participants involved in running tests must be able to run for 30 minutes (total) in bouts of at least 6 minutes, without becoming fatigued, feeling dizzy, having chest pain, or experiencing claudication symptoms.
• Participants must have no known cognitive disability.
• Participants must be fluent in spoken and written English.
• Running portions of the study will be limited to participants who self-report regular engagement in recreational or competitive running.
• Participants in the branch that uses only their own prostheses must have at least a daily use prosthesis and a running-specific prosthesis; additional prostheses may also be included
• Multiple Sclerosis group:
• For the specific subgroup targeting Multiple Sclerosis, participants must have a clinical diagnosis of Multiple Sclerosis and a clinician must determine they are experiencing foot drop.
• Participants must be able to comfortably wear and ambulate with both study devices with effective management of foot-drop, without significant discomfort

You may not qualify if:

• Target Populations:
• Allergy to electrode gel, surgical tape and metals.
• Participants who currently use the Bioness L300 Go or similar neuro-orthoses or use a carbon fiber ankle-foot orthosis at the time of the study will be excluded to avoid biasing results for one device or the other. Participants with past experience not currently using these devices will be eligible.
• Participants enrolled in physical therapy or other rehabilitative care for treatment of gait, balance, or lower extremity strength or coordination at the time of the study will be excluded to avoid confounding effects from therapy and device-based management of their condition.
• For the orthotics study, participants with peripheral neuropathy impacting control of the tibialis anterior muscle via the peroneal nerve will be excluded.
• Participants under treatment for infectious diseases will be excluded from the study.
• Women who are pregnant or planning to become pregnant during the course of the study will be excluded.
• Symptomatic musculoskeletal conditions that prevent unaided walking, such as back pain or knee arthritis.
• Cardiovascular conditions that make moderate exercise unsafe, including (but not limited to) history of angina, peripheral vascular disease, congestive heart failure, history of myocardial infarction, and history of stroke. Potential participants will be excluded if they self-report that a physician has told them to avoid moderate exercise.
• History of chest pain, shortness of breath, or claudication symptoms during ambulation
• History of significant neuropathy with altered balance
• History of serious residual limb pain or phantom limb pain within the past six months.
• History of chronic skin breakdown.
• Inability to perform the tasks involved in the study.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• United States Department of Defense: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53706-1539, United States

Location

MeSH Terms

Conditions

Peroneal Neuropathies

Interventions

Artificial Limbs; Orthotic Devices

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Artificial Organs; Surgical Equipment; Orthopedic Equipment

Results Point of Contact

• Title: Peter Adamczyk
• Organization: University of Wisconsin - Madison

peter.adamczyk@wisc.edu

(608) 263-3231

Study Officials

• Peter G Adamczyk, Ph.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will perform testing inside the laboratory ("lab testing"), outside the laboratory ("field testing") on the campus of University of Wisconsin, Madison, and/or extended testing in a home and community environment ("take-home testing") to evaluate different aspects of device function. Outcomes will generally be compared using a repeated-measures design, in which each participant acts as his/her own control. This design is chosen to minimize the statistical problems caused by heterogeneity in the participant population.

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: September 3, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 19, 2025
• Results First Posted: December 19, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)