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

Amputation Clinical Trial

Official title:

The Functional Importance of Powered Wrist Flexion for Transradial Prosthetic Users

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06420687
• Other study ID #: STU00211352
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2020
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Shirley Ryan AbilityLab
• Contact: Suzanne Finucane
• Phone: 312-238-0937
• Email: sfinucane[@]sralab.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Shirley Ryan AbilityLab	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Shirley Ryan AbilityLab	University of Alberta

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinematics data while performing the Pasta Box Task	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
Primary	Kinematics data while performing the Cup Transfer Task	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	Eye gaze data while performing the Pasta Box Task	Eye tracking hardware during prosthesis use the GAMA collects three dimensional gaze behavior and performance during simulated tasks.	After 6 week home trial
Secondary	Eye gaze data while performing the Cup Transfer Task	Eye tracking hardware during prosthesis use the GAMA collects three dimensional gaze behavior and performance during simulated tasks.	After 6 week home trial