Criteria for Advanced Prosthetic Foot Prescription

NCT ID: NCT03505983

Last Updated: 2025-04-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2025-12-31

Brief Summary

The purpose of this study is to develop criteria for prosthetic foot prescription for Veterans and Service Members with transtibial limb loss. The objectives are to: 1) Determine the appropriate functional outcome tests and measures to support the prescription of a type of Energy Storing and Returning (ESR) non-articulating, articulating or active plantarflexion prosthetic ankle-foot for a Veteran or Service Member with transtibial limb loss. 2) Correlate patient goals and subjective measures with objective data to determine the appropriate prosthetic ankle-foot category that will facilitate the greatest overall function to the user. 3) Develop criteria for the appropriate prescription of non-articulating ESR, articulating ESR, and active plantar flexion ESR ankle-foot units.

Conditions

Prosthesis User; Amputation; Traumatic, Limb, Lower

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Articulating ESR Prosthetic Foot First

Subjects will start with an Articulating ESR prosthetic foot first for 1 week, then will complete an additional week with the ESR prosthetic foot, and a powered prosthetic foot for 1 week.The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities.

Group Type: ACTIVE_COMPARATOR

Articulating ESR Prosthetic Foot First

Intervention Type: DEVICE

Subjects will start with an articulating ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.

Powered Prosthetic Foot First

Subjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot and an ESR prosthetic foot for 1 week. The final 4 weeks, all prosthetic feet will be available for use and subjects will self-select which foot to use for daily activities.

Group Type: ACTIVE_COMPARATOR

Powered Prosthetic Foot First

Intervention Type: DEVICE

Subjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR foot and an ESR foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.

ESR Prosthetic Foot First

Subject will start with an energy storing and returning (ESR) prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR prosthetic foot, and a powered prosthetic foot for 1 week. During the final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.

Group Type: ACTIVE_COMPARATOR

ESR Prosthetic Foot First

Intervention Type: DEVICE

Subjects will start with an ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.

Interventions

ESR Prosthetic Foot First

Subjects will start with an ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.

Intervention Type: DEVICE

Articulating ESR Prosthetic Foot First

Subjects will start with an articulating ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.

Intervention Type: DEVICE

Powered Prosthetic Foot First

Subjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR foot and an ESR foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.

Intervention Type: DEVICE

Other Intervention Names

Odyssey (College Park); Elan (Endolite); MotionFoot (Fillauer); Proflex (Ossur); Echelon (Endolite); Tribute (College Park); Proprio (Ossur); TruStep (College Park); Kinterra (Freedom Innovations); Flex Foot Balance with DP Flexion (Ossur); Raize (Fillauer); Echelon VT (Endolite); Triton Smart Ankle (Otto Bock); Venture (College Park); Kinnex (Freedom Innovations); emPOWER (Otto Bock)

Eligibility Criteria

Inclusion Criteria

• DEERS eligible Veteran or Service Member, or civilian with unilateral transtibial amputation
• Currently using an Energy Storing and Returning prosthetic foot with a well-fitting socket as a primary or back-up prosthesis
• Achieved a "Modified Independence" score on the Functional Independence Measure (FIM) for the locomotion mobility items
• Has a minimum clearance of 8 ¾ inches to accommodate all feet

Exclusion Criteria

• Has active wounds/ulcers or significant musculoskeletal comorbidities on their intact limb that would impair their ability to participate in all functional outcome measures
• Has any comorbidity that results in rapid limb volume changes (i.e. end stage renal disease with dialysis),
• Weighs more than 275 pounds, the maximum product weight load
• Is unable or unwilling to comply with all research visits
• Has cognitive deficit(s) or mental health pathology limiting a subject's ability to participate fully in the study
• Women who are pregnant or plan to become pregnant during study activities. This will be determined by asking the participant if they are pregnant or if they believe that they may be pregnant. This question will only be asked at inclusion, as biomechanical changes will only be impacted if the woman is in the 2nd or 3rd trimester, and will not be impacted if the participant becomes pregnant while in the study.
• Poorly fitting socket
• Vision loss that requires use of an assistive device for gait
• Upper Limb Amputation

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

James A. Haley Veterans Administration Hospital

FED

Sponsor Role: collaborator

VA Puget Sound Health Care System

FED

Sponsor Role: collaborator

VA New York Harbor Healthcare System

FED

Sponsor Role: lead

Responsible Party

Jason Maikos

Director, VISN 2 Gait and Motion Analysis Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Maikos, PhD

Role: PRINCIPAL_INVESTIGATOR

Director, VISN 2 Gait and Motion Analysis Laboratory

Locations

VA New York Harbor Healthcare System

New York, New York, United States

Countries

United States

References

Maikos JT, Hendershot BD, Pruziner AL, Hyre MJ, Chomack JM, Phillips SL, Heckman JT, Sidiropoulos AN, Dearth CL, Nelson LM. Criteria for Advanced Prosthetic Foot Prescription: Rationale, Design, and Protocol for a Multisite, Randomized Controlled Trial. JMIR Res Protoc. 2023 Apr 4;12:e45612. doi: 10.2196/45612.

Reference Type: DERIVED

PMID: 37014672 (View on PubMed)

Other Identifiers

CDMRP-OP150095

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB #01603

Identifier Type: -

Identifier Source: org_study_id