N/A
Completed N=12
Determining the Potential Benefit of Powered Prostheses
Unilateral Traumatic Amputation · Amputation, Traumatic
Source: ClinicalTrials.gov NCT02828982 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Metabolic Cost of Walking — 0.409; 0.397 J/Nm — p=0.585
Summary
The goal of this research is to determine the effectiveness of a powered prosthesis compared to an unpowered prosthesis during short bouts of walking, extended periods of walking (to fatigue), and performance in the community.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Cost of Walking |
0.409; 0.397 | 0.585 |
| PRIMARY Total Steps Outside the Home Over a Two Week Period |
2030; 1640 | 0.452 |
| PRIMARY Quality of Life (QoL) on a Short-Form 36 |
62.9; 59.4; 63.6; 67.4 | 0.480 |
| SECONDARY Prosthetic Evaluation Questionnaire (PEQ) |
75.2; 84.0; 85.6; 80.6; 66.8; 84.8 | 0.058 |
| SECONDARY Muscle Activity in the Lower Limb |
24.3; 24.1; 25.3; 28.7; 29.9; 28.6 | 0.655 |
| SECONDARY Time to Fatigue |
14.7; 13.2 | 0.212 |
Eligibility Criteria
Inclusion Criteria
- Adult (over 21 years old), Has unilateral transtibial amputation, has used prosthesis for at least 6 months, is currently using an unpowered prosthesis, can walk unassisted for at least 10 minutes
Exclusion Criteria
- History of orthopedic or neurologic disorders to their intact limb, history of cardiovascular disease that prevents them from safely completing requested activities, unable to walk for 30 minutes at a time
Data sourced from ClinicalTrials.gov (NCT02828982). 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.