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Clinical Trials/NCT06138977
NCT06138977
Recruiting
Not Applicable

Controlling Locomotion Over Continuously Varying Activities for Agile Powered Prosthetic Legs

University of Michigan1 site in 1 country40 target enrollmentDecember 6, 2023
ConditionsAmputation
InterventionsPowered prosthesis

Overview

Phase
Not Applicable
Intervention
Powered prosthesis
Conditions
Amputation
Sponsor
University of Michigan
Enrollment
40
Locations
1
Primary Endpoint
Endurance test time
Status
Recruiting
Last Updated
2 months ago

Overview

Brief Summary

The overall goal of this project is to model human joint biomechanics over continuously-varying locomotion to enable adaptive control of powered above-knee prostheses. The central hypothesis of this project is that variable joint impedance can be parameterized by a continuous model based on measurable quantities called phase and task variables. This project will use machine learning to identify variable impedance functions from able-bodied data including joint perturbation responses across the phase/task space to bias the solution toward biological values.

Detailed Description

The overall goal of this project is to model human joint biomechanics over continuously-varying locomotion to enable adaptive control of powered above-knee prostheses. Above-knee amputees often struggle to perform the varying activities of daily life with conventional prostheses due to the lack of positive mechanical work and active control. Emerging powered prostheses have motors that can perform these missing functions, but the biomechanics experienced by the user depend on the control of these motors. The way the prosthesis interacts with both the user and environment can be controlled through joint impedance--the relationship between joint motion and torque. Prosthetic joint impedance is typically defined via a stiffness, viscosity, and equilibrium angle for discrete phases of gait within a limited set of discrete activities, but this framework does not allow continuous variations of steady-state activities (e.g., walking at different speeds/inclines) or continuous transitions between activities (e.g., walk to stair ascent). The central hypothesis of this project is that variable joint impedance can be parameterized by a continuous model based on measurable quantities called phase and task variables. This project will use machine learning to identify variable impedance functions from able-bodied data including joint perturbation responses across the phase/task space to bias the solution toward biological values. The resulting impedance model will be used with real-time estimates of phase and task variables to control a custom powered knee-ankle prosthesis and the Ossur PowerKnee across activities. The clinical trial will comprise the following human subject experiments. Aim 1.3: N=5 able-bodied subjects will be recruited for initial testing of the walking and stair controllers. Once the powered knee-ankle prosthesis achieves satisfactory performance, we will enroll N=5 amputee subjects to validate these controllers. Aim 2.3: N=5 able-bodied subjects will be recruited for initial testing of the sit-to-stand and walk-stair transition controllers. Once the powered knee-ankle prosthesis achieves satisfactory performance, we will enroll N=5 amputee subjects to validate these controllers. Aim 3.1: N=5 amputee subjects will be enrolled to validate the clinical interface for the powered prosthesis controllers. Aim 3.2: N=5 amputee subjects will be enrolled to validate the transfer of the controllers to the PowerKnee. Aim 3.3: N=10 amputee subjects will be enrolled in a study of endurance and symmetry outcomes with the PowerKnee compared to their take-home prosthesis.

Registry
clinicaltrials.gov
Start Date
December 6, 2023
End Date
January 30, 2028
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Robert D Gregg

Associate Professor of Robotics, Associate Professor of Electrical Engineering and Computer Science and Associate Professor of Mechanical Engineering, College of Engineering

University of Michigan

Eligibility Criteria

Inclusion Criteria

  • for able-bodied participants will be:
  • Aged between 18 to 65 years

Exclusion Criteria

  • for able-bodied, young adult participants will be:
  • Pregnant (self-report)
  • Any significant neuromuscular or musculoskeletal disorder that would interfere with the study
  • Unable to walk for 20 minutes
  • History of any cardiovascular, vestibular, or visual diseases and/or impairments that may interfere with the study
  • Cognitive deficits that would impair their ability to give informed consent or impair their ability to follow simple instructions during the experiments. In the case of screening for cognitive deficits, the consenting researcher will ask the subject if he/she has any prior history of cognitive deficits.
  • Adults with a known allergy to medical grade tape
  • Inclusion criteria for subjects with amputation will be:
  • Aged between 18 to 70 years.
  • Weigh less than 250 lbs due to limitations in the design of the prosthesis.

Arms & Interventions

Prosthesis

Participants in this arm of the study will perform various tasks while wearing the powered prosthesis

Intervention: Powered prosthesis

Outcomes

Primary Outcomes

Endurance test time

Time Frame: 1 day

The time to complete multiple cycles through an ambulation circuit will be recorded with above-knee amputee participants' take-home prosthesis and a powered prosthesis. The ambulation circuit comprises, sit-to-stand, walking, stair ascent/descent, ramp descent/ascent, and stand-to-sit.

Joint work

Time Frame: 1 day

Mechanical work at the prosthetic knee and ankle will be assessed for participants using the powered prosthesis in A1.3 and A2.3, with comparisons to able-bodied averages. Joint work will be calculated by multiplying the joint's commanded torque by its measured velocity, resulting in units of Joules.

Tuning time

Time Frame: 1 day

The time for a prosthetist to configure the powered prosthesis for above-knee amputee participants will be assessed in A3.1 and A3.3.

Secondary Outcomes

  • Inter-leg symmetry(1 day)
  • Step length symmetry(1 day)
  • Step width symmetry(1 day)
  • Step time symmetry(1 day)
  • Prosthesis Evaluation Questionnaire-Mobility(1 day)
  • Stance-swing time ratio(1 day)

Study Sites (1)

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