Evaluation of a Powered Ankle Prosthesis Capable of Bidirectional Control Via Neural Recording and Cutaneous Stimulation in Free-Space and Walking Tasks

ConditionAmputation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorMassachusetts Institute of Technology

About this trial

The purpose of this study is to evaluate the performance of a powered ankle prosthesis capable of bidirectional control via neural recording and cutaneous stimulation, during free-space and walking tasks. This research aims to assess the sense of embodiment with the device, gait symmetry, and stability of a person with lower-extremity amputation walking with a powered ankle and their prescribed prosthesis. Findings from this study will inform future developments in bionic ankle design with optimal integration with the human body, with the goal of improving prosthetic integration into daily life.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male or Female age 18-70. The patient must have a unilateral transtibial amputation . The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).

Disqualifiers

Women who are pregnant. Severe co morbidity, atypical skeletal anatomy, or poor general physical/mental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI >40, etc.).

Trial design

Design model

Single group

Treatments tested in this trial

  • Powered Prosthesis

    Device

    This powered prosthesis has the capability of providing active neural control of an ankle joint, and its control can be adjusted through a wireless link. It is motorized to provide positive power during walking.

  • Prescribed Prosthesis

    Device

    Subject's prescribed prosthesis

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Powered ProsthesisExperimental treatment 1 intervention
Group B: Prescribed ProsthesisActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Kinematic Measures of Lower-Limb Biomechanics

Quantitative analysis of lower-limb kinematics (joint angles in degrees) during level-ground walking, stair navigation, and other functional tasks.

Time frame
Multiple sessions across 1-2 weeks
2

Kinetic Measures of Lower-Limb Biomechanics

Quantitative analysis of kinetic biomechanics including ground reaction and joint forces (Newtons) during level-ground walking, stair navigation, and other functional tasks.

Time frame
Multiple sessions across 1-2 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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