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Procedure

Powered Prosthesis for Amputation

N/A

Recruiting

Led By Robert D Gregg, PhD

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Amputee subjects with a mobility classification of K2/K3/K4 ambulators and the ability to ambulate without an assistive device beyond their prosthesis

Subjects with amputation aged between 18 to 70 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 day

Awards & highlights

Study Summary

This trial seeks to use machine learning to create better prostheses that can adapt to how the user moves. It'll use able-bodied data to create variable impedance functions that mimic biological values.

Who is the study for?

This trial is for adults aged 18-65 who are able-bodied, and those with above-knee amputations aged 18-70 who can walk without assistance. Participants must not be pregnant, have significant disorders that affect movement, or cognitive deficits. Amputees must weigh under 250 lbs and meet certain mobility classifications.Check my eligibility

What is being tested?

The study tests a powered prosthesis designed to adapt to varying activities using machine learning based on human joint biomechanics. It aims to improve the control of prosthetic legs by modeling variable joint impedance through measurable quantities in different locomotion tasks.See study design

What are the potential side effects?

While specific side effects are not detailed for this device-oriented trial, participants may experience discomfort or skin irritation from the prosthesis or medical grade tape used during testing.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an amputee who can walk with my prosthesis without needing another device.

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I am between 18 and 70 years old and have had an amputation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 day

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 day

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 day for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Endurance test time

Joint work

Tuning time

Secondary outcome measures

Inter-leg symmetry

Prosthesis Evaluation Questionnaire-Mobility

Stance-swing time ratio

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ProsthesisExperimental Treatment1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor

1,798 Previous Clinical Trials

6,378,098 Total Patients Enrolled

Robert D Gregg, PhDPrincipal InvestigatorUniversity of Michigan

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the upper age limit for this research been determined?

"As listed in the requirements, eligible patients must fall between these two ages: 18 and 65."

Answered by AI

Are there any openings to join this investigation?

"The necessary criteria for inclusion in this trial is the presence of an amputation and a patient age between 18 to 65. A total of 40 individuals are being sought after by researchers."

Answered by AI

Are there any vacant slots in this investigation for participants?

"According to clinicaltrials.gov, the study is still open for enrollment and has been since it was first posted on January 1st 2024; its most recent update was November 17th 2023."

Answered by AI

What is the maximum participant capacity for this experiment?

"Affirmative. The information on clinicaltrials.gov underlines that this examination is actively recruiting participants, which began when it was posted on January 1st 2024 and most recently modified on November 17th 2023. 40 trialists are needed across a single medical center."

Answered by AI

What outcomes is this clinical trial hoping to accomplish?

"The main metric of performance for this trial, measured over 24 hours, is Tuning Time. Secondary measurements comprise Stance-Swing Time Ratio (comparing the prosthesis to able-bodied averages), Step Time Symmetry (% difference between limbs indicating perfect symmetry) and Step Length Symmetry (% difference between limbs)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Controlling Locomotion Over Continuously Varying Activities for Agile Powered Prosthetic Legs

Robert D Gregg 2023. "Controlling Locomotion Over Continuously Varying Activities for Agile Powered Prosthetic Legs". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06138977.