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N/A N=11 Randomized Treatment

Pivot-Flex Foot: Optimal Coupling Ratio Between Transverse and Sagittal-plane Motions Using a Torsionally Adaptive Prosthesis for Individuals With Lower Limb Amputation

Lower Extremity Amputation

Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Peak Transverse-plane Prosthetic Socket Torque Normalized to Body Mass — 0.299; 0.340; 0.306; 0.292 Nm/kg — p=0.029

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Torsionally adaptive prosthesis with 0:1 coupling ratio (Device); Torsionally adaptive prosthesis with 1:6 coupling ratio (Device); Torsionally adaptive prosthesis with 1:4 coupling ratio (Device); Torsionally adaptive prosthesis with 1:3 coupling ratio (Device); Torsionally adaptive prosthesis with 1:2 coupling ratio (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Oct 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Peak Transverse-plane Prosthetic Socket Torque Normalized to Body Mass
0.299; 0.340; 0.306; 0.292; 0.324; 0.306 0.029 sig
SECONDARY
Satisfaction With the Prosthesis
8.0; 7.5; 7.7; 8.2; 7.9; 7.9

Summary

When prescribing a prosthetic foot, clinicians face a dizzying array of choices as more than 200 different prosthetic feet are available. While these conventional prosthetic feet primarily function in the sagittal plane, the intact foot and ankle comprise a complex set of joints that allow rotation in multiple planes of motion. Some of these motions are coupled, meaning rotation in one plane induces motion in another. One such coupling is between the sagittal and transverse planes. For every step, plantar- and dorsi-flexion motion in the sagittal plane is coupled with external and internal rotation of the shank relative to the foot in the transverse plane. There is no prosthetic foot available for prescription that mimics this natural coupling. To investigate the need for this coupling, the investigators have built a torsionally adaptive prosthesis where the coupling ratio between the transverse- and sagittal-planes can be independently controlled with a motor. This research has one specific aim: to identify the optimal coupling ratio between transverse- and sagittal-plane motions using a novel, torsionally adaptive prosthesis for individuals with lower limb amputation. The investigators will conduct a human subject experiment wearing the motor-driven and computer controlled torsionally adaptive prosthesis. Individuals with lower limb amputation will be asked to walk in a straight line and in both directions around a circle while the coupling ratio between transverse- and sagittal-plane motions is varied between trials. Participants will be blinded to the coupling ratio. The investigators hypothesize that: (1) a coupling ratio exists that minimizes undesirable transverse-plane socket torque and (2) there will be a coupling ratio that individuals with lower limb amputation prefer.

Eligibility Criteria

Inclusion Criteria

  • Unilateral transtibial amputation
  • Been fit with a prosthesis and used it for at least six months
  • Wear the prosthesis for four or more hours on an average day
  • Prescribed prosthesis can accommodate fitment of the study prosthetic components to be tested (determined at initial visit)

Exclusion Criteria

  • Improper fit and suspension with current prosthesis and one cannot be achieved with clinical resources (determined at initial visit)
  • Current skin irritation or injury on residual limb
  • Osteoarthritis, injury, or pain that interferes with walking ability
  • Currently incarcerated
  • Pregnant (determined via self-report)
  • Inadequate cognitive function or language proficiency to consent to participate
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03532100). 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.

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