GaMA Metric to Quantify Functional Importance of Various Upper Limb Prosthetic Devices
NCT ID: NCT06420687
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
45 participants
INTERVENTIONAL
2020-04-20
2025-09-30
Brief Summary
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Detailed Description
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The Gaze and Movement Assessment (GaMA) is a new validated and standardized metric to quantify the functional characteristics of prosthesis use by quantifying motion (three dimensional angular kinematics), gaze behavior and performance during simulated real-world tasks. There are two tasks, the Cup Transfer Task and the Pasta Box Task, used with the GAMA testing hardware. The tasks require movements representing day-to-day functional requirements, while challenging typical prosthetic limitations such as reaching and transporting objects at varying heights and across the body and lack of wrist motion. Each task can be subdivided into specific phases of reaching, grasping, transporting and releasing objects. A performance aspect encourages the participant to work efficiently, and tasks are short to allow multiple repetitions within a reasonable testing time frame to assess performance consistency. By breaking down each task into movements (i.e., of the pasta box from one shelf to the next), and each movement into specific phases (reach, grasp, transport, and release), the investigators can examine these components individually. It is hypothesized that additional degrees-of-freedom (for example wrist flexion) may require more time but will reduce the compensatory movements required to complete the tasks.
The primary endpoint of the study is to quantify the effect of various prosthetics components on kinematics.
The secondary endpoint is to obtain normative data for the GaMA system and system validation.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
BASIC_SCIENCE
NONE
Study Groups
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Able-bodied participants
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.
No interventions assigned to this group
Transradial amputee participants
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.
Clinically prescribed prosthesis
Clinically prescribed prosthesis:
Transradial amputee participants - Wrist rotation+1 dof hand
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.
Experimental prosthesis - Wrist rotation + 1-DOF
1-DOF wrist rotation and1-DOF hand
Transradial amputee participants - Wrist rotation + wrist flexion +1 dof hand
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.
Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOF
2-DOF wrist (rotation and flexion) and 1-DOF hand
Transradial amputee participants - Wrist rotation + multi degree freedom hand
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.
Experimental prosthesis - Wrist rotation + Multi DOF hand
1-DOF wrist rotation and multi-DOF hand
Transradial amputee participants - Wrist rotation + wrist flexion + multi degree freedom hand
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.
Experimental prosthesis - Wrist rotation + wrist flexion + Multi DOF hand
2-DOF wrist (rotation and flexion) and multi-DOF hand
Interventions
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Clinically prescribed prosthesis
Clinically prescribed prosthesis:
Experimental prosthesis - Wrist rotation + 1-DOF
1-DOF wrist rotation and1-DOF hand
Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOF
2-DOF wrist (rotation and flexion) and 1-DOF hand
Experimental prosthesis - Wrist rotation + Multi DOF hand
1-DOF wrist rotation and multi-DOF hand
Experimental prosthesis - Wrist rotation + wrist flexion + Multi DOF hand
2-DOF wrist (rotation and flexion) and multi-DOF hand
Eligibility Criteria
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Inclusion Criteria
* Ability to use a myoelectric prosthesis
* English Speaking
Exclusion Criteria
* 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.
* 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
18 Years
70 Years
ALL
Yes
Sponsors
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University of Alberta
OTHER
Shirley Ryan AbilityLab
OTHER
Responsible Party
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Laura Miller
Team Scientist III
Locations
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Shirley Ryan AbilityLab
Chicago, Illinois, United States
Countries
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Other Identifiers
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STU00211352
Identifier Type: -
Identifier Source: org_study_id
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