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GaMA Metric to Quantify Functional Importance of Various Upper Limb Prosthetic Devices

The Functional Importance of Powered Wrist Flexion for Transradial Prosthetic Users

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06420687
Enrollment
45
Registered
2024-05-20
Start date
2020-04-20
Completion date
2025-09-30
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amputation, Amputation, Traumatic, Amputation; Traumatic, Hand, Amputation; Traumatic, Limb

Keywords

Upper Limb Prosthetic Users

Brief summary

The goal of this study is to utilize the Gaze and Movement Assessment (GaMA) metric to assess the effect of different prosthetic components on compensatory movements used to complete activities of daily living.

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.

Interventions

DEVICEClinically prescribed prosthesis

Clinically prescribed prosthesis:

DEVICEExperimental prosthesis - Wrist rotation + 1-DOF

1-DOF wrist rotation and1-DOF hand

DEVICEExperimental prosthesis - Wrist rotation + Wrist flexion +1-DOF

2-DOF wrist (rotation and flexion) and 1-DOF hand

DEVICEExperimental prosthesis - Wrist rotation + Multi DOF hand

1-DOF wrist rotation and multi-DOF hand

DEVICEExperimental prosthesis - Wrist rotation + wrist flexion + Multi DOF hand

2-DOF wrist (rotation and flexion) and multi-DOF hand

Sponsors

University of Alberta
CollaboratorOTHER
Shirley Ryan AbilityLab
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

The GaMA metric will utilize motion capture and eye tracking hardware and software during the administration of functional tasks while research participants are using commercially available prosthetic devices and investigational prosthetic devices currently in development.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Kinematics data while performing the Pasta Box TaskAfter 6-week home trialUtilizes 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.
Kinematics data while performing the Cup Transfer TaskAfter 6-week home trialUtilizes 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.

Secondary

MeasureTime frameDescription
Eye gaze data while performing the Pasta Box TaskAfter 6 week home trialEye tracking hardware during prosthesis use the GAMA collects three dimensional gaze behavior and performance during simulated tasks.
Eye gaze data while performing the Cup Transfer TaskAfter 6 week home trialEye tracking hardware during prosthesis use the GAMA collects three dimensional gaze behavior and performance during simulated tasks.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026