N/A
Completed N=36
Evaluation of a Modified Running-specific Prosthetic Foot
Transtibial Amputation
Source: ClinicalTrials.gov NCT02440711 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Metabolic Oxygen Consumption (VO2), Participants With Unilateral Amputation — 1041.1; 1077.4; 1210.9; 1253.5 ml/min — p=.18
Summary
The goal of this study is to evaluate endurance, walking performance, mobility, and perceived exertion of transtibial prosthesis users (i.e., study participants) walking with a conventional energy storing prosthetic foot (ESF) and a novel modified running-specific prosthesis (mRSF). A randomized cross-over study will be conducted to determine if the mRSF provides superior performance to the ESF, which is commonly prescribed to most active individuals with lower limb amputation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Metabolic Oxygen Consumption (VO2), Participants With Unilateral Amputation |
1041.1; 1077.4; 1210.9; 1253.5; 1509.6; 1565.1 | .18 |
| PRIMARY Metabolic Oxygen Consumption (VO2), Participants With Bilateral Amputation |
779.6; 867.3; 889.9; 985.0; 1081.9; 1162.8 | — |
| PRIMARY Six-minute Walk Test (6MWT), Participants With Unilateral Amputation |
543.3; 537.1 | .29 |
| PRIMARY Six-minute Walk Test (6MWT), Participants With Bilateral Amputation |
441.1; 448.9 | — |
| PRIMARY Borg Rating of Perceived Exertion (CR100), Participants With Unilateral Amputation |
36.4; 47.3 | 0.05 |
| PRIMARY Borg Rating of Perceived Exertion (CR100), Participants With Bilateral Amputation |
30.4; 35.6 | — |
| PRIMARY Walking Speed, Participants With Unilateral Amputation |
1.62; 1.60 | .25 |
| PRIMARY Walking Speed, Participants With Bilateral Amputation |
1.35; 1.35 | — |
| PRIMARY Step Width, Participants With Unilateral Amputation |
13.7; 13.7 | .86 |
| PRIMARY Step Width, Participants With Bilateral Amputation |
16.9; 16.7 | — |
| PRIMARY Step Length, Participants With Unilateral Amputation |
78.8; 79.4; 79.5; 76.5 | .14 |
| PRIMARY Step Length, Participants With Bilateral Amputation |
0.69; 0.68; 0.69; 0.69 | — |
| PRIMARY Step Time, Participants With Unilateral Amputation |
0.49; 0.49; 0.50; 0.50 | .61 |
| PRIMARY Step Time, Participants With Bilateral Amputation |
0.53; 0.52; 0.51; 0.51 | — |
| SECONDARY Daily Step Activity, Participants With Unilateral Amputation |
4109; 4307 | .14 |
| SECONDARY Daily Step Activity, Participants With Bilateral Amputation |
2464; 3007 | — |
| SECONDARY Prosthetic Limb Users Survey of Mobility (PLUS-M), Participants With Unilateral Amputation |
64.2; 59.3 | 0.001 sig |
| SECONDARY Prosthetic Limb Users Survey of Mobility (PLUS-M), Participants With Bilateral Amputation |
59.3; 54.8 | — |
| SECONDARY Patient Reported Outcome Measurement Information System - Fatigue (PROMIS-Fatigue), Participants With Unilateral Amputation |
45.4; 49.1 | 0.001 sig |
| SECONDARY Patient Reported Outcome Measurement Information System - Fatigue (PROMIS-Fatigue), Participants With Bilateral Amputation |
42.1; 47.7 | — |
| SECONDARY Activities-Specific Balance Confidence Scale (ABC), Participants With Unilateral Amputation |
3.5; 3.2 | 0.005 sig |
| SECONDARY Activities-Specific Balance Confidence Scale (ABC), Participants With Bilateral Amputation |
3.4; 3.0 | — |
| SECONDARY Trinity Amputation Prosthesis Experience Scales, Revised (TAPES-R), Participants With Unilateral Amputation |
0.4; 0.6; 1.8; 1.3; 1.5; 1.5 | 0.002 sig |
| SECONDARY Trinity Amputation Prosthesis Experience Scales, Revised (TAPES-R), Participants With Bilateral Amputation |
0.7; 0.9; 1.8; 1.1; 1.8; 0.9 | — |
Eligibility Criteria
Inclusion Criteria
- unilateral or bilateral, transtibial (below-knee) amputation from non-dysvascular causes
- Medicare functional classification level (K-level) 3 or higher (unlimited community ambulatory)
- prosthetic user for > 1 year
- scheduled to receive a mRSF prosthesis
- able and willing to participate in the study protocol (e.g., treadmill walking, overground walking, respond to survey questions, able to read and write English)
Exclusion Criteria
- contralateral lower or upper limb involvement
- any health condition that would limit participation in the study procedures (e.g., skin breakdown, heart disease)
Data sourced from ClinicalTrials.gov (NCT02440711). 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.