N/A N=31 Device Feasibility

Community Walking Trials: Comparing Prosthetic Feet

Lower Extremity Amputation

Bottom Line

View on ClinicalTrials.gov: NCT03703232 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2024

Primary outcome: Primary: Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Ambulation Sub-Scale — 4.2 score on a scale — p=0.092

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Investigational prosthetic foot (Device)
Age: Pediatric, Adult, Older Adult · 16+ yrs
Sex: All
Sponsor: University of Washington
Primary completion: Jun 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Ambulation Sub-Scale	4.2	0.092
PRIMARY Difference Between Investigational Foot and Usual Foot in the Comprehensive Lower Extremity Amputee Socket Survey (CLASS): Comfort Scale	1.1	0.760
PRIMARY Difference Between Investigational Foot and Usual Foot in the Figure-of-8 Walking Test: Time	-0.53	0.007 sig
PRIMARY Difference Between Investigational Foot and Usual Foot in the Daily Activity Log: Scale Measuring How Prosthesis Helps or Hinders When Walking on a Challenging Surface	10.5	0.003 sig
SECONDARY Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Residual Limb Health Subscale	1.6	0.861
SECONDARY Difference Between Investigational Foot and Usual Foot in the Comprehensive Lower Extremity Amputee Socket Survey (CLASS): Stability Subscale	3.2	—
SECONDARY Difference Between Investigational Foot and Usual Foot in the Narrowing Beam Walking Test: Distance Travelled	0.45	0.405
SECONDARY Difference Between Investigational Foot and Usual Foot in the Daily Activity Log: Balance Confidence	-0.2	0.798
SECONDARY Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Utility Subscale	4.2	0.382
SECONDARY Difference Between Investigational Foot and Usual Foot in the Prosthetic Evaluation Questionnaire (PEQ): Sound Subscale	-8.9	0.179
SECONDARY Difference Between Investigational Foot and Usual Foot in the Comprehensive Lower Extremity Amputee Socket Survey (CLASS): Suspension Subscales	0.2	0.984

Summary

The purpose of the study is to obtain performance measurements and participant feedback about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot. To accomplish this, the study will use a combination of laboratory motion analysis, functional tests, and community mobility trials where participants complete questionnaires and interviews about use of an investigational prosthetic foot compared to the participant's usual prosthetic foot. Individuals with amputations that participate in the (optional) motion analysis sub-study at the University of Washington will complete forward walking, side-step, and across river rock with usual foot (session 1), and also with the investigational foot locked and unlocked (session 2) after an accommodation period of between 1-4 weeks. The participants will rate their experiences using socket comfort score and the socket pressure score. Control participants recruited at the University of Washington to provide information about performance for people without amputation will go through the consenting process, then will be asked to complete forward walking, Figure-of-8 Walk Test, Narrowing Beam Walking Test, side-step, and walking across river rock surface. These tests will be conducted at a single session.

Eligibility Criteria

Inclusion Criteria

Unilateral below knee amputation, use a prosthetic foot for at least 1 year
Ability to walk 400 meters on level ground without using a walking aid and without an increase in pain
Ability to read, write, and comprehend English

Exclusion Criteria

Residual skin breakdown
Weight over 300 lbs

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03703232). 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.