Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis
Evaluation of Functional Performance of Persons With Limb Differences to Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis
This study is focused on optimizing methods for controlling upper-limb myoelectric prosthetic arms. If you are enrolled in this study you would be expected to visit one of the research sites for approximately 5 in-lab visits lasting about 4 hours. These visits are expected to happen within a 5-week period but may take longer depending on scheduling availability. During these visits you will be completing basic tasks similar to your everyday actions using a prosthetic arm that is provided for you.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Craig M Kelly
- Phone Number: 508-893-6363
- Email: craig.kelly@liberatingtech.com
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Shirley Ryan AbilityLab
-
Contact:
- Craig M Kelly
- Phone Number: 508-893-6363
- Email: craig.kelly@liberatingtech.com
-
-
Massachusetts
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Holliston, Massachusetts, United States, 01746
- Recruiting
- Liberating Technologies, Inc. (LTI)
-
Contact:
- Craig M Kelly
- Phone Number: 508-893-6363
- Email: craig.kelly@liberatingtech.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged 18 years or older
- Unilateral transradial level limb difference
- Current or past user of myo-electric controlled prostheses
- Six months or more post-amputation
- Have adequate limb length such that a wrist rotation device can fit in the check socket
- Have adequate limb length and diameter such that at least 9 channels of electrodes fit without cross pairing
- Well-fitting socket as determined by a Socket-Comfort Score of 6 or above
- Capable of wearing and operating a prosthesis with a wrist rotator and multi-articulating hand
- Capable of understanding and following multi-step instructions and completing the tasks as described
- English speaking
Exclusion Criteria:
- Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.
- Cognitive impairment that would adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.
- Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers.
- Pregnant participants as risk to pregnant individuals, embryos, or fetuses are not understood.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Sequence 1
Each arm will test all 4 conditions but in a different order from each other. |
Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. |
|
Experimental: Sequence 2
Each arm will test all 4 conditions but in a different order from each other. |
Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. |
|
Experimental: Sequence 3
Each arm will test all 4 conditions but in a different order from each other. |
Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. |
|
Experimental: Sequence 4
Each arm will test all 4 conditions but in a different order from each other. |
Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. Each intervention is a specific blinded number and location of electrodes within the prosthetic arm used to control the prosthetic arm with pattern recognition myoelectric control. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
ACMC
Time Frame: Through study completion, an average of 1 month, 1 time at each 4 site visits.
|
The participant will complete a daily task (such as packing a suitcase) using their prosthetic arm. A study occupational therapist will score the participants ability along different metrics. |
Through study completion, an average of 1 month, 1 time at each 4 site visits.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Todd Farrell, PhD, Liberating Technologies, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- E03209.1a
- W81XWH2210431 (Other Grant/Funding Number: U.S. Army Medical Research Acquisition Activity)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Deidentified outcomes results for participants such as ACMC, clothespin relocation task, and virtual EMG measures.
IPD Sharing Time Frame
Data will be shared by June 2029 and available indefinitely.
IPD Sharing Access Criteria
Anyone will be able to access all the shared IPD on a public data repository such as FigShare or ICPSR.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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