NCT07159490

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 3, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 1, 2022

Completed
3.3 years until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
4 months until next milestone

Results Posted

Study results publicly available

February 12, 2026

Completed
Last Updated

February 12, 2026

Status Verified

January 1, 2026

Enrollment Period

4.8 years

First QC Date

June 1, 2022

Results QC Date

January 8, 2026

Last Update Submit

January 26, 2026

Conditions

AmputationProsthesis User

Keywords

Lower limb prosthesisTranstibial amputationBelow knee amputationBiomechanics

Outcome Measures

Primary Outcomes (5)

  • Vertical Ground Reaction Force Impulse (Normalized)

    A measure of body support. Normalized by body mass, including the mass of the load when applicable.

    During study visit (approximately 3 hours)

  • Anterior Ground Reaction Force Impulse (Normalized)

    A measure of body forward propulsion. Normalized by body mass, including the mass of the load when applicable.

    During study visit (approximately 3 hours)

  • Peak-to-peak Range of Sagittal Plane Whole-body Angular Momentum (Normalized)

    A measure of balance control primarily for anterior and posterior added load conditions. Normalized by body mass (kg) including the mass of the load when applicable, body height (m), and \[gravity\*body height\]\^0.5 (m/s) resulting in a unitless number.

    During study visit (approximately 3 hours)

  • Peak-to-peak Range of Coronal Plane Whole-body Angular Momentum (Normalized)

    A measure of balance control primarily for intact-side added load conditions. Normalized by body mass (kg) including the mass of the load when applicable, body height (m), and \[gravity\*body height\]\^0.5 (m/s) resulting in a unitless number.

    During study visit (approximately 3 hours)

  • Net Positive Ankle Joint Mechanical Work Over the Prosthetic Limb Gait Cycle (Normalized)

    Positive ankle joint mechanical work over the prosthetic limb gait cycle is a measure of propulsion capability. A prosthetic foot with greater propulsion capability may enhance gait efficiency during everyday ambulation. Normalized to body mass and the added load mass when applicable.

    During study visit (approximately 3 hours)

Study Arms (5)

No added load

EXPERIMENTAL

Study participants will walk with no added load.

Device: Standard-of-care prosthetic footDevice: Standard-of-care prosthetic foot with heel-stiffening wedgeDevice: Standard-of-care prosthetic foot of one category greater stiffnessDevice: Dual keel prosthetic footDevice: Powered ankle-foot

Anterior added load

EXPERIMENTAL

Study participants will walk with 13.6 kg (30 lbs) of added load on their anterior side.

Device: Standard-of-care prosthetic footDevice: Standard-of-care prosthetic foot with heel-stiffening wedgeDevice: Standard-of-care prosthetic foot of one category greater stiffnessDevice: Dual keel prosthetic footDevice: Powered ankle-foot

Posterior added load

EXPERIMENTAL

Study participants will walk with 13.6 kg (30 lbs) of added load on their posterior side.

Device: Standard-of-care prosthetic footDevice: Standard-of-care prosthetic foot with heel-stiffening wedgeDevice: Standard-of-care prosthetic foot of one category greater stiffnessDevice: Dual keel prosthetic footDevice: Powered ankle-foot

Intact-side added load

EXPERIMENTAL

Study participants will walk with 13.6 kg (30 lbs) of added load on their intact side.

Device: Standard-of-care prosthetic footDevice: Standard-of-care prosthetic foot with heel-stiffening wedgeDevice: Standard-of-care prosthetic foot of one category greater stiffnessDevice: Dual keel prosthetic footDevice: Powered ankle-foot

Prosthetic-side added load

EXPERIMENTAL

Study participants will walk with 13.6 kg (30 lbs) of added load on their prosthetic side.

Device: Standard-of-care prosthetic footDevice: Standard-of-care prosthetic foot with heel-stiffening wedgeDevice: Standard-of-care prosthetic foot of one category greater stiffnessDevice: Dual keel prosthetic footDevice: Powered ankle-foot

Interventions

Standard-of-care prosthetic foot with heel-stiffening wedgeDEVICE

Widely prescribed prosthetic foot with a wedge inserted between the heel and foot keels intended to stiffen the behavior of the heel.

Also known as: Sierra, Freedom Innovations
Anterior added loadIntact-side added loadNo added loadPosterior added loadProsthetic-side added load
Standard-of-care prosthetic foot of one category greater stiffnessDEVICE

Widely prescribed prosthetic foot of one stiffness category greater than usually prescribed based on the participant's body weight and activity level.

Also known as: Sierra, Freedom Innovations
Anterior added loadIntact-side added loadNo added loadPosterior added loadProsthetic-side added load
Dual keel prosthetic footDEVICE

A prosthetic foot with two forefoot keels intended for load carriage applications.

Also known as: Thrive, Freedom Innovations
Anterior added loadIntact-side added loadNo added loadPosterior added loadProsthetic-side added load
Powered ankle-footDEVICE

A powered prosthetic ankle-foot.

Also known as: Empower, Otto Bock
Anterior added loadIntact-side added loadNo added loadPosterior added loadProsthetic-side added load
Standard-of-care prosthetic footDEVICE

Widely prescribed prosthetic foot of stiffness category appropriate to the participant's body weight and activity level.

Also known as: Sierra, Freedom Innovations
Anterior added loadIntact-side added loadNo added loadPosterior added loadProsthetic-side added load

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System Seattle Division

Seattle, Washington, 98108, United States

Location

MeSH Terms

Interventions

Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Glenn Klute, PhD
Organization
VA Center for Limb Loss and MoBility
Glenn.Klute@va.gov
206-277-2962

Study Officials

  • Glenn Klute, PhD

    VA Puget Sound Care System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
A sock and foot cover to blind the participants to the study prostheses when possible (use of the powered ankle-foot will be obvious).
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: This study will employ a within-subject experimental design. Each participant will wear, in randomized order, a standard-of-care prosthetic foot, this same prosthetic foot with a heel-stiffening wedge, this same prosthetic foot but one category stiffer, a dual keel prosthetic foot intended for load carriage applications, and a powered ankle-foot purported to adapt to changing loads. All study prostheses are commercially available. Each participant, wearing each of the study prostheses, will walk overground with no added load and four added load conditions of 13.6 kg: anterior, posterior, intact-side carry, and prosthetic-side carry. The load condition will be presented in block randomized order.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Career Scientist / Affiliate Professor

Study Record Dates

First Submitted

June 1, 2022

First Posted

September 8, 2025

Study Start

December 3, 2020

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

February 12, 2026

Results First Posted

February 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

A de-identified, anonymized dataset in machine-readable format will be created and shared for all individual participant data (IPD) that underlie results in a publication. The investigators will follow 164.514(a) of the HIPAA Privacy Rule for de-identification of IPD.

Time Frame
Within six months after publication of final study findings.
Access Criteria
Open-source data repository (e.g., PubMed Central)

Locations

US(1)