CompletedNot Applicable

Lower Limb Prostheses for Individuals Who Carry Infants, Toddlers, and Other Loads

United States13 participantsStarted 2020-12-03

Plain-language summary

The aim of this research is to identify the prosthetic foot that results in improved walking performance when individuals with lower limb amputation carry infants, toddlers, or other loads.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Unilateral transtibial amputee
. Have been fitted with and used a prosthesis for at least six months
. Do not use heel stiffening wedges or bumpers in their as-prescribed prosthesis
. Wear their prosthesis for at least four hours per day
. Are moderately active by self-report
. Can be fitted with the study prostheses (prosthetic foot size, stiffness category and build heights)

Exclusion criteria

. Do not have a proper fit and suspension and one cannot be achieved with clinical resources
. Presence of disorder, pain, or injury other than amputation that interferes with gait

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Vertical Ground Reaction Force Impulse (Normalized)

Timeframe: During study visit (approximately 3 hours)

Anterior Ground Reaction Force Impulse (Normalized)

Timeframe: During study visit (approximately 3 hours)

Peak-to-peak Range of Sagittal Plane Whole-body Angular Momentum (Normalized)

Timeframe: During study visit (approximately 3 hours)

Peak-to-peak Range of Coronal Plane Whole-body Angular Momentum (Normalized)

Timeframe: During study visit (approximately 3 hours)

Net Positive Ankle Joint Mechanical Work Over the Prosthetic Limb Gait Cycle (Normalized)

Timeframe: During study visit (approximately 3 hours)

Trial details

NCT IDNCT07159490

SponsorVA Puget Sound Health Care System

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2025-10-01

Results submitted2026-01-08

View on ClinicalTrials.gov More Amputation trials

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Unilateral transtibial amputee
. Have been fitted with and used a prosthesis for at least six months
. Do not use heel stiffening wedges or bumpers in their as-prescribed prosthesis
. Wear their prosthesis for at least four hours per day
. Are moderately active by self-report
. Can be fitted with the study prostheses (prosthetic foot size, stiffness category and build heights)

Exclusion criteria

. Do not have a proper fit and suspension and one cannot be achieved with clinical resources
. Presence of disorder, pain, or injury other than amputation that interferes with gait

What they're measuring

Vertical Ground Reaction Force Impulse (Normalized)

Timeframe: During study visit (approximately 3 hours)

Anterior Ground Reaction Force Impulse (Normalized)

Timeframe: During study visit (approximately 3 hours)

Peak-to-peak Range of Sagittal Plane Whole-body Angular Momentum (Normalized)

Timeframe: During study visit (approximately 3 hours)

Peak-to-peak Range of Coronal Plane Whole-body Angular Momentum (Normalized)

Timeframe: During study visit (approximately 3 hours)

Net Positive Ankle Joint Mechanical Work Over the Prosthetic Limb Gait Cycle (Normalized)

Timeframe: During study visit (approximately 3 hours)