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Prosthesis

Upper Limb Prosthetics for Amputation

N/A
Recruiting
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
A unilateral upper limb amputation or absence below the elbow
Ability to use a myoelectric prosthesis
Must not have
Cognitive impairment sufficient to 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 in order for the study to generate useable, reliable data.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 6 week home trial
Awards & highlights

Summary

This trial aims to use a metric called Gaze and Movement Assessment (GaMA) to see how different prosthetic components affect the way people move to do everyday tasks.

Who is the study for?
This trial is for individuals with a unilateral upper limb amputation below the elbow who can use a myoelectric prosthesis and speak English. It excludes those with cognitive impairments affecting study participation, significant other comorbidities, or new injuries preventing prosthesis use.
What is being tested?
The study evaluates how different prosthetic components affect daily living activities using the GaMA metric. Participants will try various experimental prostheses that offer wrist rotation, multi-degree-of-freedom hands, and wrist flexion to measure their functionality.
What are the potential side effects?
While not explicitly stated, potential side effects may include discomfort from wearing different prosthetic devices, skin irritation at the site of contact with the device, or muscle strain due to adapting to new movement patterns.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have one arm amputated or missing below the elbow.
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I can use a limb prosthesis controlled by muscle signals.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I understand and can follow the study's requirements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after 6-week home trial
This trial's timeline: 3 weeks for screening, Varies for treatment, and after 6-week home trial for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Kinematics data while performing the Cup Transfer Task
Kinematics data while performing the Pasta Box Task
Secondary outcome measures
Eye gaze data while performing the Cup Transfer Task
Eye gaze data while performing the Pasta Box Task

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Transradial amputee participants - Wrist rotation+1 dof handExperimental Treatment1 Intervention
Individuals with transradial amputation fit with experimental prosthesis consisting of wrist rotation and one degree of freedom hand. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights.
Group II: Transradial amputee participants - Wrist rotation + wrist flexion +1 dof handExperimental Treatment1 Intervention
Individuals with transradial amputation fit with experimental prosthesis consisting of wrist rotation, wrist flexion and one degree of freedom hand. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights.
Group III: Transradial amputee participants - Wrist rotation + wrist flexion + multi degree freedom handExperimental Treatment1 Intervention
Individuals with transradial amputation fit with experimental prosthesis consisting of wrist rotation, wrist flexion and multi degree freedom hand. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights.
Group IV: Transradial amputee participants - Wrist rotation + multi degree freedom handExperimental Treatment1 Intervention
Individuals with transradial amputation fit with experimental prosthesis consisting of wrist rotation and multi degree freedom hand. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights.
Group V: Able-bodied participantsActive Control1 Intervention
Participants without amputation were enrolled to collect normative data for system validation. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant wears a specialized headband/glasses with an attached camera for eye tracking. The participant will pick up and move objects of different shapes to and from various heights.
Group VI: Transradial amputee participantsActive Control1 Intervention
Individuals using their home prosthesis when available. Adhesive motion capture markers will be placed on both arms (upper arm, forearm, hand and finger tips), thoracic spine and sacrum. The participant will wear a headband with attached markers for eye tracking. The participant will pick up and move objects of different shapes to and from various heights.

Find a Location

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
204 Previous Clinical Trials
17,794 Total Patients Enrolled
University of AlbertaOTHER
913 Previous Clinical Trials
390,388 Total Patients Enrolled
~8 spots leftby Sep 2025
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