AmputationNCT06420687
GaMA Metric to Quantify Functional Importance of Various Upper Limb Prosthetic Devices
A study testing Clinically prescribed prosthesis, Experimental prosthesis - Wrist rotation + 1-DOF and Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOF in people with Amputation and Amputation, Traumatic, run by Shirley Ryan AbilityLab at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation, Amputation, Traumatic, Amputation; Traumatic, Hand
- What is being tested?
- Clinically prescribed prosthesis, Experimental prosthesis - Wrist rotation + 1-DOF and Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOF
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2020to Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A unilateral upper limb amputation or absence below the elbow
- Ability to use a myoelectric prosthesis
- English Speaking
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Functional Importance of Powered Wrist Flexion for Transradial Prosthetic Users
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.
Read the 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.
- Conditions
- Amputation, Amputation, Traumatic, Amputation; Traumatic, Hand, Amputation; Traumatic, Limb
- Being tested
- Clinically prescribed prosthesis, Experimental prosthesis - Wrist rotation + 1-DOF, Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOF, Experimental prosthesis - Wrist rotation + Multi DOF hand, Experimental prosthesis - Wrist rotation + wrist flexion + Multi DOF hand
- Keywords
- Upper Limb Prosthetic Users
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinically prescribed prosthesisDevice
Clinically prescribed prosthesis:
Experimental prosthesis - Wrist rotation + 1-DOFDevice
1-DOF wrist rotation and1-DOF hand
Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOFDevice
2-DOF wrist (rotation and flexion) and 1-DOF hand
Experimental prosthesis - Wrist rotation + Multi DOF handDevice
1-DOF wrist rotation and multi-DOF hand
Experimental prosthesis - Wrist rotation + wrist flexion + Multi DOF handDevice
2-DOF wrist (rotation and flexion) and multi-DOF hand
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Experimental prosthesis - Wrist rotation + wrist flexion + Multi DOF hand |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After 6-week home trial
Secondary outcomes (2)
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.
Measured: After 6 week home trial
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.
Measured: After 6 week home trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start20 Apr 2020
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- 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.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta
- Responsible party
- Principal investigator, Laura Miller, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06420687
- Sponsor's protocol ID
- STU00211352
- Status last verified
- Mar 2025
- First submitted
- 13 May 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Functional Importance of Powered Wrist Flexion for Transradial Prosthetic Users
- ClinicalTrials.gov ID
- NCT06420687
- Acronym / sponsor ID
- STU00211352
- Conditions
- Amputation, Amputation, Traumatic, Amputation; Traumatic, Hand, Amputation; Traumatic, Limb
- Keywords
- Upper Limb Prosthetic Users
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Collaborators
- University of Alberta
- Study start
- 20 Apr 2020 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 6
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: Clinically prescribed prosthesisIndividuals 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. |
| Transradial amputee participants - Wrist rotation+1 dof hand | Experimental | Device: Experimental prosthesis - Wrist rotation + 1-DOFIndividuals 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. |
| Transradial amputee participants - Wrist rotation + wrist flexion +1 dof hand | Experimental | Device: Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOFIndividuals 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. |
| Transradial amputee participants - Wrist rotation + multi degree freedom hand | Experimental | Device: Experimental prosthesis - Wrist rotation + Multi DOF handIndividuals 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. |
| Transradial amputee participants - Wrist rotation + wrist flexion + multi degree freedom hand | Experimental | Device: Experimental prosthesis - Wrist rotation + wrist flexion + Multi DOF handIndividuals 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A unilateral upper limb amputation or absence below the elbow
- Ability to use a myoelectric prosthesis
- English Speaking
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinically prescribed prosthesisClinically prescribed prosthesis: | Device | Transradial amputee participants |
| Experimental prosthesis - Wrist rotation + 1-DOF1-DOF wrist rotation and1-DOF hand | Device | Transradial amputee participants - Wrist rotation+1 dof hand |
| Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOF2-DOF wrist (rotation and flexion) and 1-DOF hand | Device | Transradial amputee participants - Wrist rotation + wrist flexion +1 dof hand |
| Experimental prosthesis - Wrist rotation + Multi DOF hand1-DOF wrist rotation and multi-DOF hand | Device | Transradial amputee participants - Wrist rotation + multi degree freedom hand |
| Experimental prosthesis - Wrist rotation + wrist flexion + Multi DOF hand2-DOF wrist (rotation and flexion) and multi-DOF hand | Device | Transradial amputee participants - Wrist rotation + wrist flexion + multi degree freedom hand |
Primary outcome
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.
Kinematics data while performing the Cup Transfer 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. 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.
2 secondary outcomes
Eye gaze data while performing the Pasta Box Task
Time frame: After 6 week home trial
Eye gaze data while performing the Cup Transfer Task
Time frame: After 6 week home trial
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinically prescribed prosthesis, Experimental prosthesis - Wrist rotation + 1-DOF and Experimental prosthesis - Wrist rotation + Wrist flexion +1-DOF in people with Amputation and Amputation, Traumatic, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kinematics data while performing the Pasta Box Task (time frame: After 6-week home trial). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.