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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
Select...
I am an amputee who can walk with my prosthesis without needing another device.
Select...
I am between 18 and 70 years old and have had an amputation.

Timeline

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

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Who is running the clinical trial?

University of MichiganLead Sponsor
1,813 Previous Clinical Trials
6,383,582 Total Patients Enrolled
Robert D Gregg, PhDPrincipal InvestigatorUniversity of Michigan
~27 spots leftby Jan 2028
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