Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05840601 |
| Other study ID # |
271065 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 22, 2022 |
| Est. completion date |
April 20, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
Liberating Technologies, Inc. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
