GaMA Metric to Quantify Functional Importance of Various Upper Limb Prosthetic Devices
The Functional Importance of Powered Wrist Flexion for Transradial Prosthetic Users
Study Overview
Status
Intervention / Treatment
- Device: Clinically prescribed prosthesis
- Device: Experimental prosthesis - Wrist rotation + 1-DOF
- Device: Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOF
- Device: Experimental prosthesis - Wrist rotation + Multi DOF hand
- Device: Experimental prosthesis - Wrist rotation + wrist flexion + Multi DOF hand
Detailed Description
Evaluating the benefit of new prosthetic components and control mechanisms can be challenging, as most validated outcome measures assess the time required to complete various tasks without assessing the quality of the movement or the specific DOF(s) activated to accomplish the task. There are no adequate methods to evaluate the impact of new technology. The functional outcome measures recommended by The Academy of Prosthetics and Orthotics Upper Limb Prosthetic Outcome Measures (ULPOM) committee, which provided recommendations for measuring functional effectiveness of prosthetic treatment, mainly focus on the time to complete the task rather than assessing the compensatory movements.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60611
- Shirley Ryan Abilitylab
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- A unilateral upper limb amputation or absence below the elbow
- Ability to use a myoelectric prosthesis
- 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 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 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.
|
|
|
Active Comparator: 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:
|
|
Experimental: 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.
|
1-DOF wrist rotation and1-DOF hand
|
|
Experimental: 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.
|
2-DOF wrist (rotation and flexion) and 1-DOF hand
|
|
Experimental: 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.
|
1-DOF wrist rotation and multi-DOF hand
|
|
Experimental: 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.
|
2-DOF wrist (rotation and flexion) and multi-DOF hand
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Kinematics data while performing the Pasta Box Task
Time Frame: After 6-week home trial
|
Utilizes motion capture hardware during prosthesis use and collects three dimensional angular kinematics, gaze behavior and performance during simulated tasks. Participants move a pasta box from the target on a side cart at the right side of the body onto a mid-height shelf target in front of them. Then they move the box from the mid-height shelf target to the high shelf target on the opposite side. Finally, they pick up the pasta box from the high shelf target and return it to the initial position. Each task can be subdivided into specific phases of reaching, grasping, transporting and releasing objects. By breaking down each task into movements, and each movement into specific phases (reach, grasp, transport, and release), the investigators can examine these components individually. |
After 6-week home trial
|
|
Kinematics data while performing the Cup Transfer Task
Time Frame: After 6-week home trial
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Utilizes motion capture hardware during prosthesis use and collects three dimensional angular kinematics, gaze behavior and performance during simulated tasks. The Cup transfer task consists of moving two cups filled with beads (simulating being filled with liquid) over a partition and back again for a total of four object movements. The cups are deformable and will spill beads if grabbed too hard. Like in the Pasta task, participants start each trial with their hand in the home position and their eyes fixated on a centered motion capture marker. Each task can be subdivided into specific phases of reaching, grasping, transporting and releasing objects. By breaking down each task into movements, and each movement into specific phases (reach, grasp, transport, and release), the investigators can examine these components individually. |
After 6-week home trial
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eye gaze data while performing the Pasta Box Task
Time Frame: After 6 week home trial
|
Eye tracking hardware during prosthesis use the GAMA collects three dimensional gaze behavior and performance during simulated tasks.
|
After 6 week home trial
|
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Eye gaze data while performing the Cup Transfer Task
Time Frame: After 6 week home trial
|
Eye tracking hardware during prosthesis use the GAMA collects three dimensional gaze behavior and performance during simulated tasks.
|
After 6 week home trial
|
Collaborators and Investigators
Sponsor
Collaborators
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU00211352
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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