Adaptive control of powered prosthetic legs for amputees
Controlling Locomotion Over Continuously Varying Activities for Agile Powered Prosthetic Legs
This study is testing a new way to make powered prosthetic legs work better for amputees by adapting to different walking speeds and activities.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Michigan Academic / other |
| Locations | 1 site (Ann Arbor, Michigan) |
| Trial ID | NCT06138977 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance the functionality of powered above-knee prostheses by modeling human joint biomechanics during various locomotion activities. It focuses on developing a continuous model of joint impedance that can adapt to different walking speeds and transitions between activities. By utilizing machine learning, the study will analyze able-bodied data to create variable impedance functions that mimic biological movement. The ultimate goal is to improve the control of prosthetic devices, allowing amputees to perform daily activities more effectively.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 years who have undergone above-knee amputation and weigh less than 250 lbs.
Not a fit: Patients with significant neuromuscular or musculoskeletal disorders, cognitive deficits, or those who are unable to walk for 20 minutes may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the mobility and quality of life for individuals with above-knee amputations.
How similar studies have performed: While the approach of using machine learning for adaptive control in prosthetics is innovative, similar studies have shown promise in enhancing prosthetic functionality.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ann Arbor, Michigan
- Rehab Lab, University of Michigan — Ann Arbor, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Robert D Gregg, PhD — University of Michigan
- Study coordinator: Emily Klinkman, MS
- Email: emilykk@umich.edu
- Phone: 734-846-0046
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.