Recruiting

Joint Biomechanics

Sponsor:

University of Michigan

Code:

NCT06138977

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Powered prosthesis

Study Details

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.

Conditions

Amputation

Study ID

NCT06138977

Start date

Dec 6, 2023

Status verified date

Sep, 2026

Completion date

Jan 30, 2028

Anticipated

Primary completion date

Jan 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.
  • 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.

Exclusion criteria for subjects with amputation will be:

  • 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
  • Cognitive deficits or visual impairment 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.
  • Co-morbidity that interferes with the study (e.g., pace maker placement, severe ischemia, cardiac disease, etc.)
  • Adults unable to consent
  • Adults with a known allergy to medical grade tape

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Prosthesis

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

Interventions

Powered prosthesis

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

Primary outcome measure

  • Joint work [ Time Frame: 1 day ]
  • Tuning time [ Time Frame: 1 day ]
  • Endurance test time [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Kashvi Pota, MS

734-763-1156kashvip@umich.edu

Robert D Gregg, PhD

734-763-1156rdgregg@umich.edu

Locations

Rehab Lab, University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Kashvi Pota, MS

734-763-1156kashvip@umich.edu

More Information

Sponsor

University of Michigan

Last update posted

Sep 16, 2026

Last verified

Sep, 2026

Keywords

  • prosthetic leg

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-09-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.