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

NCT06420687 | Active Not Recruiting

• 1 other identifier: STU00211352
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Upper Limb Prosthetic Users

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Eye gaze data while performing the Pasta Box Task

  After 6 week home trial

• Eye gaze data while performing the Cup Transfer Task

  After 6 week home trial

Study Arms (6)

Able-bodied participants

NO INTERVENTION

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.

Transradial amputee participants

ACTIVE COMPARATOR

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.

Device: Clinically prescribed prosthesis

Transradial amputee participants - Wrist rotation+1 dof hand

EXPERIMENTAL

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.

Device: Experimental prosthesis - Wrist rotation + 1-DOF

Transradial amputee participants - Wrist rotation + wrist flexion +1 dof hand

EXPERIMENTAL

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.

Device: Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOF

Transradial amputee participants - Wrist rotation + multi degree freedom hand

EXPERIMENTAL

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.

Device: Experimental prosthesis - Wrist rotation + Multi DOF hand

Transradial amputee participants - Wrist rotation + wrist flexion + multi degree freedom hand

EXPERIMENTAL

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.

Device: Experimental prosthesis - Wrist rotation + wrist flexion + Multi DOF hand

Interventions

Clinically prescribed prosthesis DEVICE

Clinically prescribed prosthesis:

Transradial amputee participants

Experimental prosthesis - Wrist rotation + 1-DOF DEVICE

1-DOF wrist rotation and1-DOF hand

Transradial amputee participants - Wrist rotation+1 dof hand

Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOF DEVICE

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

Transradial amputee participants - Wrist rotation + wrist flexion +1 dof hand

Experimental prosthesis - Wrist rotation + Multi DOF hand DEVICE

1-DOF wrist rotation and multi-DOF hand

Transradial amputee participants - Wrist rotation + multi degree freedom hand

Experimental prosthesis - Wrist rotation + wrist flexion + Multi DOF hand DEVICE

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

Transradial amputee participants - Wrist rotation + wrist flexion + multi degree freedom hand

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A unilateral upper limb amputation or absence below the elbow
• Ability to use a myoelectric prosthesis
• English Speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Shirley Ryan AbilityLab: lead
• University of Alberta: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Team Scientist III

Model Details: 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.

Study Record Dates

• First Submitted: May 13, 2024
• First Posted: May 20, 2024
• Study Start: April 20, 2020
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

US (1)