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 range18 Years – 70 Years

SexALL

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)

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 range18 Years – 70 Years

SexALL

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)