N/A
Completed N=12
Lower Limb Prostheses for Individuals Who Carry Infants, Toddlers, and Other Loads
Amputation · Prosthesis User
Source: ClinicalTrials.gov NCT07159490 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcomePrimary: Vertical Ground Reaction Force Impulse (Normalized) — 5.24; 5.30; 5.27; 5.33 Newtons*seconds/kg — p=0.100
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vertical Ground Reaction Force Impulse (Normalized) |
5.24; 5.30; 5.27; 5.33; 5.46; 5.37 | 0.100 |
| PRIMARY Anterior Ground Reaction Force Impulse (Normalized) |
0.232; 0.228; 0.213; 0.214; .257; 0.236 | 0.011 sig |
| PRIMARY Peak-to-peak Range of Sagittal Plane Whole-body Angular Momentum (Normalized) |
.0172; .0165; .0164; .0160; .0153; .0151 | <0.010 sig |
| PRIMARY Peak-to-peak Range of Coronal Plane Whole-body Angular Momentum (Normalized) |
0.0109; .0109; .0111; .0109; .0120; .0094 | .079 |
| PRIMARY Net Positive Ankle Joint Mechanical Work Over the Prosthetic Limb Gait Cycle (Normalized) |
.158; .150; .133; .127; .228; .161 | .0033 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT07159490). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.