NCT06138977 Controlling Locomotion Over Continuously Varying Activities for Agile Powered Prosthetic Legs
| NCT ID | NCT06138977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-12-06 |
| Primary Completion | 2028-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-12-06 with a primary completion date of 2028-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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. * 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
Contact & Investigator
Robert D Gregg, PhD
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT06138977 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06138977 currently recruiting?
Yes, NCT06138977 is actively recruiting participants. Contact the research team at emilykk@umich.edu for enrollment information.
Where is the NCT06138977 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT06138977 clinical trial?
NCT06138977 is sponsored by University of Michigan. The principal investigator is Robert D Gregg, PhD at University of Michigan. The trial plans to enroll 40 participants.