AmputationNCT05840601
Evaluation of Dexterous Terminal Device
A study testing Pointdexter and Comparator in people with Amputation and Amputation, Traumatic, run by Liberating Technologies, Inc..
Trial summary
Liberating Technologies, Inc. (LTI) has developed Pointdexter, a dexterous prosthetic fingertip that is integrated into a commercial prosthetic hand and allows for an additional fine grasp. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Amputation, Amputation, Traumatic, Amputation; Traumatic, Hand
- What is being tested?
- Pointdexter and Comparator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 22 Dec 2022to 20 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have an upper limb absence
- Uses myoelectric control for their prosthesis
- If they have a major upper limb absence, must use a quick-disconnect wrist
- If able-bodied, must be willing to use an upper-limb prosthesis bypass for testing
- Willing and able to complete activities outlined in the study and provide requested feedback.
- Adults must be able to provide their own consent.
Who cannot join
- The risks to pregnant people and fetuses are unknown and therefore those who are pregnant should not participate in the study and will be screened by self-disclosure.
About this study
Liberating Technologies, Inc. (LTI) has developed Pointdexter, a dexterous prosthetic fingertip that is integrated into a commercial prosthetic hand and allows for an additional fine grasp. The Pointdexter device interfaces with upper limb prostheses by swapping the usual prosthetic pointer finger with the Pointdexter device. The dexterous prosthetic fingertip utilizes the same control strategy used to operate the prosthetic hand. This solution aims to combine the advantages of the common terminal devices into one product by combining the practicality and dexterity of a split-hook or gripper with the aesthetics of multi-articulating hands.
Read the detailed description
Liberating Technologies, Inc. (LTI) has developed Pointdexter, a dexterous prosthetic fingertip that is integrated into a commercial prosthetic hand and allows for an additional fine grasp. The Pointdexter device interfaces with upper limb prostheses by swapping the usual prosthetic pointer finger with the Pointdexter device. The dexterous prosthetic fingertip utilizes the same control strategy used to operate the prosthetic hand. This solution aims to combine the advantages of the common terminal devices into one product by combining the practicality and dexterity of a split-hook or gripper with the aesthetics of multi-articulating hands.
The rationale for this study is to pilot test the dexterous prosthetic fingertip and gather user feedback. We will conduct in-lab testing to compare the functional outcomes of a commercial prosthetic hand with and without integration of the investigational dexterous fingertip prosthesis. A subset of subjects will take home the device for up to 2 weeks to test out the functionality in their daily lives and provide further feedback. This will be an exploratory pilot study with the intention of gaining a better understanding of device operation throughout activities of daily living (ADLs). User feedback will be collected to inform further development and design.
The study will focus on design feasibility testing and will compare performance of hand functional outcome tests on a commercially available prosthetic hand with and without the investigational Pointdexter modification. Our primary hypothesis is that subjects using the investigational device will show better performance on objective functional outcomes measures than those using a standard prosthetic hand, particularly in the manipulation of small objects.
The investigators will explore multiple outcomes measures as options, but our primary endpoint will be performance on the Small Common Objects subtask of the Jebsen-Taylor Hand Function Test, which assesses a broad range of unimanual hand functions required for ADLs. The primary quantitative measure of the Jebsen-Taylor task will be completion time of each subtask. Myoelectric prosthetic hand users will be recruited for the study and consented with an approved protocol. Able-bodied participants will be recruited for this study as long as they are willing to complete the approved protocol with an upper-limb prosthesis bypass.
There will be one site visit at LTI in Holliston, MA for in-lab functional outcome measure testing. The subject may be asked to return to the lab if testing and/or data collection is incomplete. At the start of the study session, subjects will prepare for testing in their first configuration (investigational or comparator). If investigational, subjects will doff their prosthesis and investigators will replace the usual index finger of the commercially available prosthetic hand being tested with the investigational device. If comparator, subjects will don the unmodified commercially available prosthetic hand. Subjects will be trained on how to operate the investigational device and be allowed a minimum of 30 minutes to practice using it until they are comfortable with proceeding. The subjects will be guided to conduct functional outcome tests that involve picking up and manipulating everyday objects (beans, coins, pegs, spoon, cloth, etc.), such as the tasks outlined in the Jebsen-Taylor and Peg Board functional tests. Each sub-task in the functional test will be scored by occupational therapist standards. After a round of functional testing is done, subjects will fill out a subjective questionnaire. Subjects will then doff the prosthesis and don the next device configuration. Subjects will repeat the functional tests and questionnaire with each device configuration. The study session should span about 4 hours.
A subset of subjects will use the investigational device in their daily lives in place of their usual prosthesis for up to 2 weeks and provide feedback of their experiences with the dexterous prosthetic fingertip. To improve subject convenience and expand our pool of subjects, the take-home study is able to be done fully remote by providing the option to consent through secure voice/video calling and shipping the investigational device to/from the subject.
Upper limb myoelectric prosthesis users and able-bodied individuals will be invited to participate in the study. Research participants will schedule a time to conduct the testing and be informed of study details. Participants will be given as much time as needed to review and question the informed consent form before signing.
Two different technologies will be assessed:
- Investigational Device: Commercially available prosthetic hand with dexterous fingertip modification
- Comparator Baseline: Unmodified commercially available prosthetic hand
Upper limb prosthesis users as well as able-bodied individuals will be recruited for this study through the LTI clinician network and subject database. Prosthetists may be contacted to recruit research subjects and, if interested, will be given flyers to hand out to their patients. If subjects are interested in participating, they can call the number on the flyer to speak with investigators. In addition, previous research participants who have given their permission to be contacted for future studies may be contacted directly to assess their interest in participating in this study.
Based on subject population and availability, a convenience sample of 10 subjects will be recruited for this pilot study.
- Conditions
- Amputation, Amputation, Traumatic, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper, Prosthesis User, Upper Limb Amputation Below Elbow (Injury)
- Being tested
- Pointdexter, Comparator
- Keywords
- amputee, upper limb amputee, upper limb prosthesis user, prosthesis, upper limb absence, dexterous fingertip, index finger prosthesis
- Medical subject headings
- Amputation, Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PointdexterDevice
Also called Dexterous Terminal Device
Commercially available prosthetic hand modified with the investigational Pointdexter finger in place of the usual index finger.
ComparatorDevice
Unmodified commercially available prosthetic hand.
| Study group | Role | What they receive |
|---|---|---|
| Pointdexter | Experimental | The investigational device being tested is Pointdexter, a novel prosthetic finger with a built-in split gripper. The device is an index finger which can drop in place of existing fingers on a prosthetic hand. The investigational device is controlled with the same signals used to control the hand. Participants will use a commercially available prosthetic hand compatible with the Pointdexter device for this study. Receives: Device: Pointdexter |
| Comparator | Active comparator | The comparator device is the same commercially available hand that is being used for the Pointdexter arm, except that it will be unmodified (i.e., it will have its usual index finger attached instead of the Pointdexter finger). Receives: Device: Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Jebsen-Taylor Small Common Objects Functional Test
During the in-lab portion of the study, subjects will be asked to complete the 'small common objects' subtask of the Jebsen-Taylor Hand Function Test, which assesses a broad range of unimanual hand functions required for ADLs. The primary quantitative measure of the Jebsen-Taylor task will be completion time of each subtask. This test will be used to evaluate the feasibility of the device design as compared with the unmodified prosthetic hand.
Measured: 4 hours
Secondary outcomes (1)
User Feedback
Investigators will collect feedback about the device design and how the user would compare manipulating common objects with the investigational device vs. a commercially available prosthetic hand.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start22 Dec 2022
- Primary completion20 Apr 2023
- Study completion20 Apr 2023
Why it stopped: Grant concluded.
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.
- 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
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- In the lab, a functional test will be used to evaluate the feasibility of the device design as compared with a baseline condition. A subset of these subjects will test the investigational device at home for up to 2 weeks to provide feedback on the investigational device when used in everyday tasks.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liberating Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05840601
- Sponsor's protocol ID
- 271065
- Status last verified
- Nov 2024
- First submitted
- 21 Apr 2023
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study withdrawn - no participants recruited and no data collected.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Dexterous Terminal Device
- ClinicalTrials.gov ID
- NCT05840601
- Acronym / sponsor ID
- 271065
- Conditions
- Amputation, Amputation, Traumatic, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper, Prosthesis User, Upper Limb Amputation Below Elbow (Injury)
- Keywords
- amputee, upper limb amputee, upper limb prosthesis user, prosthesis, upper limb absence, dexterous fingertip, index finger prosthesis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Grant concluded.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Liberating Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 20 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 3 May 2023 (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.
Liberating Technologies, Inc. (LTI) has developed Pointdexter, a dexterous prosthetic fingertip that is integrated into a commercial prosthetic hand and allows for an additional fine grasp. The Pointdexter device interfaces with upper limb prostheses by swapping the usual prosthetic pointer finger with the Pointdexter device. The dexterous prosthetic fingertip utilizes the same control strategy used to operate the prosthetic hand. This solution aims to combine the advantages of the common terminal devices into one product by combining the practicality and dexterity of a split-hook or gripper with the aesthetics of multi-articulating hands.
Detailed description
Liberating Technologies, Inc. (LTI) has developed Pointdexter, a dexterous prosthetic fingertip that is integrated into a commercial prosthetic hand and allows for an additional fine grasp. The Pointdexter device interfaces with upper limb prostheses by swapping the usual prosthetic pointer finger with the Pointdexter device. The dexterous prosthetic fingertip utilizes the same control strategy used to operate the prosthetic hand. This solution aims to combine the advantages of the common terminal devices into one product by combining the practicality and dexterity of a split-hook or gripper with the aesthetics of multi-articulating hands.
The rationale for this study is to pilot test the dexterous prosthetic fingertip and gather user feedback. We will conduct in-lab testing to compare the functional outcomes of a commercial prosthetic hand with and without integration of the investigational dexterous fingertip prosthesis. A subset of subjects will take home the device for up to 2 weeks to test out the functionality in their daily lives and provide further feedback. This will be an exploratory pilot study with the intention of gaining a better understanding of device operation throughout activities of daily living (ADLs). User feedback will be collected to inform further development and design.
The study will focus on design feasibility testing and will compare performance of hand functional outcome tests on a commercially available prosthetic hand with and without the investigational Pointdexter modification. Our primary hypothesis is that subjects using the investigational device will show better performance on objective functional outcomes measures than those using a standard prosthetic hand, particularly in the manipulation of small objects.
The investigators will explore multiple outcomes measures as options, but our primary endpoint will be performance on the Small Common Objects subtask of the Jebsen-Taylor Hand Function Test, which assesses a broad range of unimanual hand functions required for ADLs. The primary quantitative measure of the Jebsen-Taylor task will be completion time of each subtask. Myoelectric prosthetic hand users will be recruited for the study and consented with an approved protocol. Able-bodied participants will be recruited for this study as long as they are willing to complete the approved protocol with an upper-limb prosthesis bypass.
There will be one site visit at LTI in Holliston, MA for in-lab functional outcome measure testing. The subject may be asked to return to the lab if testing and/or data collection is incomplete. At the start of the study session, subjects will prepare for testing in their first configuration (investigational or comparator). If investigational, subjects will doff their prosthesis and investigators will replace the usual index finger of the commercially available prosthetic hand being tested with the investigational device. If comparator, subjects will don the unmodified commercially available prosthetic hand. Subjects will be trained on how to operate the investigational device and be allowed a minimum of 30 minutes to practice using it until they are comfortable with proceeding. The subjects will be guided to conduct functional outcome tests that involve picking up and manipulating everyday objects (beans, coins, pegs, spoon, cloth, etc.), such as the tasks outlined in the Jebsen-Taylor and Peg Board functional tests. Each sub-task in the functional test will be scored by occupational therapist standards. After a round of functional testing is done, subjects will fill out a subjective questionnaire. Subjects will then doff the prosthesis and don the next device configuration. Subjects will repeat the functional tests and questionnaire with each device configuration. The study session should span about 4 hours.
A subset of subjects will use the investigational device in their daily lives in place of their usual prosthesis for up to 2 weeks and provide feedback of their experiences with the dexterous prosthetic fingertip. To improve subject convenience and expand our pool of subjects, the take-home study is able to be done fully remote by providing the option to consent through secure voice/video calling and shipping the investigational device to/from the subject.
Upper limb myoelectric prosthesis users and able-bodied individuals will be invited to participate in the study. Research participants will schedule a time to conduct the testing and be informed of study details. Participants will be given as much time as needed to review and question the informed consent form before signing.
Two different technologies will be assessed:
- Investigational Device: Commercially available prosthetic hand with dexterous fingertip modification
- Comparator Baseline: Unmodified commercially available prosthetic hand
Upper limb prosthesis users as well as able-bodied individuals will be recruited for this study through the LTI clinician network and subject database. Prosthetists may be contacted to recruit research subjects and, if interested, will be given flyers to hand out to their patients. If subjects are interested in participating, they can call the number on the flyer to speak with investigators. In addition, previous research participants who have given their permission to be contacted for future studies may be contacted directly to assess their interest in participating in this study.
Based on subject population and availability, a convenience sample of 10 subjects will be recruited for this pilot study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In the lab, a functional test will be used to evaluate the feasibility of the device design as compared with a baseline condition. A subset of these subjects will test the investigational device at home for up to 2 weeks to provide feedback on the investigational device when used in everyday tasks.
| Arm | Type | Receives |
|---|---|---|
| Pointdexter | Experimental | Device: PointdexterThe investigational device being tested is Pointdexter, a novel prosthetic finger with a built-in split gripper. The device is an index finger which can drop in place of existing fingers on a prosthetic hand. The investigational device is controlled with the same signals used to control the hand. Participants will use a commercially available prosthetic hand compatible with the Pointdexter device for this study. |
| Comparator | Active comparator | Device: ComparatorThe comparator device is the same commercially available hand that is being used for the Pointdexter arm, except that it will be unmodified (i.e., it will have its usual index finger attached instead of the Pointdexter finger). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Have an upper limb absence
- Uses myoelectric control for their prosthesis
- If they have a major upper limb absence, must use a quick-disconnect wrist
- If able-bodied, must be willing to use an upper-limb prosthesis bypass for testing
- Willing and able to complete activities outlined in the study and provide requested feedback.
Key exclusion criteria (1 listed)
- The risks to pregnant people and fetuses are unknown and therefore those who are pregnant should not participate in the study and will be screened by self-disclosure.
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 |
|---|---|---|
| PointdexterAlso: Dexterous Terminal DeviceCommercially available prosthetic hand modified with the investigational Pointdexter finger in place of the usual index finger. | Device | Pointdexter |
| ComparatorUnmodified commercially available prosthetic hand. | Device | Comparator |
Primary outcome
Jebsen-Taylor Small Common Objects Functional Test
Time frame: 4 hours
During the in-lab portion of the study, subjects will be asked to complete the 'small common objects' subtask of the Jebsen-Taylor Hand Function Test, which assesses a broad range of unimanual hand functions required for ADLs. The primary quantitative measure of the Jebsen-Taylor task will be completion time of each subtask. This test will be used to evaluate the feasibility of the device design as compared with the unmodified prosthetic hand.
1 secondary outcome
User Feedback
Time frame: 4 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Presentation - Initial Clinical Evaluation of Pointdexter - A Dexterous Prosthetic FingertipLink provided by the sponsor.
- Individual participant dataSharing planned: No. Study withdrawn - no participants recruited and no data collected.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Pointdexter and Comparator in people with Amputation and Amputation, Traumatic, run by Liberating Technologies, Inc..
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 6 inclusion and 1 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: withdrawn, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Jebsen-Taylor Small Common Objects Functional Test (time frame: 4 hours). 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 25 Nov 2024.