Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420687
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2024-05-13
Brief Title:
GaMA Metric to Quantify Functional Importance of Various Upper Limb Prosthetic Devices
Sponsor:
Shirley Ryan AbilityLab
Organization:
Shirley Ryan AbilityLab
Study Overview
Official Title:
The Functional Importance of Powered Wrist Flexion for Transradial Prosthetic Users
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 DOFs 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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None