N/A N=36 Randomized Treatment

Evaluation of a Modified Running-specific Prosthetic Foot

Transtibial Amputation

Bottom Line

View on ClinicalTrials.gov: NCT02440711 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2023

Primary outcome: Primary: Metabolic Oxygen Consumption (VO2), Participants With Unilateral Amputation — 1041.1; 1077.4; 1210.9; 1253.5 ml/min — p=.18

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Energy storing foot (ESF) (Device); Modified running specific foot (mRSF) (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Mar 2018

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	—

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.

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)

View full record on ClinicalTrials.gov →

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.