Criteria for Advanced Prosthetic Foot Prescription

NCT03505983 | Active Not Recruiting

• 2 other identifiers: IRB #01603CDMRP-OP150095
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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

Amputation; Traumatic, Limb, Lower; Prosthesis User

Keywords

Prosthetic Limb Design; Prosthesis Fitting

Outcome Measures

Primary Outcomes (7)

• Change in 6-min walk distance for each prosthetic foot type

  The 6-minute walk test measures the distance an individual can walk in 6 minutes without help or encouragement.

  Once per week, at Week 1, Week 2, and Week 3 after enrollment

• Change in TUG times for each prosthetic foot type

  The TUG measures the time taken by an individual to stand up from a standard arm chair, walk a distance of 10 feet, turn, walk back to the chair, and sit down.

  Once per week, at Week 1, Week 2, and Week 3 after enrollment

• Change in 4SST times for each prosthetic foot type

  The four-square step test is a higher order complex task assessing dynamic balance.

  Once per week, at Week 1, Week 2, and Week 3 after enrollment

• Change in AmpPRO for each prosthetic foot type

  The AmpPro is a 21-item instrument designed to measure basic prosthetic mobility of individuals with lower extremity amputation.

  Once per week, at Week 1, Week 2, and Week 3 after enrollment

• Change in Stair Assessment Index (SAI) for each prosthetic foot type

  The SAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a staircase.

  Once per week, at Week 1, Week 2, and Week 3 after enrollment

• Change in Hill Assessment Index (HAI) for each prosthetic foot type

  The HAI is a rated qualitative scale on how an individual with lower limb amputation negotiates up and down a ramp.

  Once per week, at Week 1, Week 2, and Week 3 after enrollment

• Change in Gait Evaluation for each prosthetic foot type

  Biomechanical evaluation of gait.

  Once per week, at Week 1, Week 2, and Week 3 after enrollment

Secondary Outcomes (5)

• Change in Prosthetic Evaluation Questionnaire (PEQ) score for each prosthetic foot type

  Once per week, at Week 1, Week 2, and Week 3 after enrollment

• Change in Short Form (SF)-12 for each prosthetic foot type

  Once per week, at Week 1, Week 2, and Week 3 after enrollment

• Change in OPUS for each prosthetic foot type

  Once per week, at Week 1, Week 2, and Week 3 after enrollment

• Final Visit Guided Interview

  Administered one time at Final Visit, which will occur 7 weeks after enrollment.

• Change in responses to Prosthetic Evaluation Questionnaire-Addendum (PEQ-A) for each prosthetic foot type

  Once per week, at Week 1, Week 2, and Week 3 after enrollment

Study Arms (3)

Articulating ESR Prosthetic Foot First

ACTIVE COMPARATOR

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.

Device: Articulating ESR Prosthetic Foot First

Powered Prosthetic Foot First

ACTIVE COMPARATOR

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.

Device: Powered Prosthetic Foot First

ESR Prosthetic Foot First

ACTIVE COMPARATOR

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.

Device: ESR Prosthetic Foot First

Interventions

Powered Prosthetic Foot First 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.

Also known as: emPOWER (Otto Bock)

Powered Prosthetic Foot First

ESR Prosthetic Foot First 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.

ESR Prosthetic Foot First

Articulating ESR Prosthetic Foot First 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.

Also known as: 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)

Articulating ESR Prosthetic Foot First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Poorly fitting socket
• Vision loss that requires use of an assistive device for gait
• Upper Limb Amputation

Sponsors & Collaborators

• VA New York Harbor Healthcare System: lead
• Walter Reed National Military Medical Center: collaborator
• James A. Haley Veterans Administration Hospital: collaborator
• VA Puget Sound Health Care System: collaborator

Study Sites (1)

VA New York Harbor Healthcare System

New York, New York, 10010, United States

Location

Related Publications (1)

• 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.

  PMID: 37014672 DERIVED

Study Officials

• Jason Maikos, PhD

  Director, VISN 2 Gait and Motion Analysis Laboratory

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor and statistician will be blinded to foot type during data processing and analysis
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, VISN 2 Gait and Motion Analysis Laboratory

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: April 23, 2018
• Study Start: March 7, 2018
• Primary Completion: September 14, 2023
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)