NCT06138977

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
21mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress59%
Dec 2023Jan 2028

First Submitted

Initial submission to the registry

November 13, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

December 6, 2023

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2028

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

4.2 years

First QC Date

November 13, 2023

Last Update Submit

February 10, 2026

Conditions

Keywords

prosthetic leg

Outcome Measures

Primary Outcomes (3)

  • Joint work

    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.

    1 day

  • Tuning time

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

    1 day

  • Endurance test time

    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.

    1 day

Secondary Outcomes (6)

  • Inter-leg symmetry

    1 day

  • Stance-swing time ratio

    1 day

  • Step time symmetry

    1 day

  • Step length symmetry

    1 day

  • Step width symmetry

    1 day

  • +1 more secondary outcomes

Study Arms (1)

Prosthesis

EXPERIMENTAL

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

Device: Powered prosthesis

Interventions

A powered prosthesis will be used to restore normative leg biomechanics to above-knee amputee participants during different activities of daily life.

Prosthesis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 18 to 65 years

You may not qualify if:

  • 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
  • Aged between 18 to 70 years.
  • Weigh less than 250 lbs due to limitations in the design of the prosthesis.
  • Amputee subjects will be more than two months post independent ambulation with an amputation at the transfemoral level in order to use the above-knee prosthesis.
  • Amputee subjects will have a mobility classification of K2/K3/K4 ambulators (minimum community ambulatory) and have the ability to ambulate without an assistive device beyond their prosthesis.
  • Weigh over 250 pounds body
  • Pregnant (self-report)
  • Any significant neuromuscular or musculoskeletal disorder that would interfere with the study
  • Inactive or physically unfit, unable to walk for 20 minutes
  • An excessively long residual limb length, and/or a non-removable cosmetic cover determined by the prosthetist performing the evaluations
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehab Lab, University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Related Publications (1)

  • Best TK, Seelhoff CA, Wensman J, Gregg RD. The clinical effects of the Ossur Power Knee with phase-based and default control during sitting, standing, and walking. J Neuroeng Rehabil. 2025 Sep 29;22(1):200. doi: 10.1186/s12984-025-01729-2.

Study Officials

  • Robert D Gregg, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emily Klinkman, MS

CONTACT

Robert D Gregg, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Robotics, Associate Professor of Electrical Engineering and Computer Science and Associate Professor of Mechanical Engineering, College of Engineering

Study Record Dates

First Submitted

November 13, 2023

First Posted

November 18, 2023

Study Start

December 6, 2023

Primary Completion (Estimated)

January 30, 2028

Study Completion (Estimated)

January 30, 2028

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified IPD will be shared upon publication.

Shared Documents
STUDY PROTOCOL

Locations