Comparison of Various Prosthetic Foot-Ankle Mechanisms

Part of paid clinical trials in Cambridge, Massachusetts.

Sponsor
Massachusetts Institute of Technology
Study ID
NCT05964855
Status
Enrolling By Invitation

Conditions

  • Transtibial Amputation - Unilateral

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • MIT Variable Stiffness Prosthesis — DEVICE
    Proprietary electronically-controlled prosthesis that can vary its effective stiffness.
  • MIT Variable Equilibrium Angle Prosthesis — DEVICE
    Proprietary manually-controlled prosthesis that can vary its effective ankle equilibrium angle.
  • MIT Sliding Beam Passive Prosthesis — DEVICE
    Proprietary fixed-stiffness passive foot-ankle prosthesis.
  • Ossur Pro-flex XC — DEVICE
    Commercially-available passive fixed-stiffness foot-ankle prosthesis by Ossur.
  • Blatchford Elan Variable-Dampening Prosthesis — DEVICE
    Commercially-available electronically-controlled prosthesis that can vary its effective dampening.

Study Details

In summary, subjects will be asked to wear a number of sensors and use different ankle-foot prostheses in place of their customary prosthesis. Data will be collected from the wearable sensors, VICON motion capture system, video cameras, and force sensors in the ground as they walk on level-ground, on a treadmill, and on stairs. The controller of any powered prosthesis will be electronically adjusted between trials or while the subject walks to determine how their gait changes in response to these changes. Trials will also be conducted with a standard passive prosthesis that would be prescribed for a person of similar height and weight.

Key Dates

Start date
Jul 28, 2023
Status verified
Jan 2025
Primary completion
Sep 1, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Unilateral Subject Group
    Foot-ankle devices will be given to this group to evaluate and compare the devices.

Primary Outcome Measure

User device preference for level-ground walking [ Time Frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient) ]

Locations (1)

FacilityCityStateZIPSite coordinators
MIT Media LaboratoryCambridgeMassachusetts02139-

Find similar trials in Cambridge, MA

By research site
MIT Media Laboratory· Cambridge, MA

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