AmputationNCT05038566
Dexterous Partial Hand Prosthesis Outcomes
A study testing Pointdexter in people with Amputation and Amputation; Traumatic, Hand, run by Liberating Technologies, Inc. at 2 sites in United States.
Trial summary
Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Amputation, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper
- What is being tested?
- Pointdexter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Jul 2021to 28 Apr 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Must have an upper limb partial hand absence.
- Must be new or current i-Digits prosthesis users.
- Must have an absent index finger at minimum.
- Must be able to understand spoken and written English in order to be properly consented and provide feedback to the study personnel.
- Must be willing and able to complete outlined tasks and provide feedback on the intervention.
Who cannot join
- The risks to pregnant women and fetuses are unknown and therefore pregnant women should not participate in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Össur Academy - Touch Solutions
Dublin, Ohio, 43017
Liberating Technologies, Inc.
Holliston, Massachusetts, 01746
About this study
Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp. The device will interface with research participants' existing prostheses and use the same control strategy that is used for their everyday use. Each participant's prosthesis will be restored to their original configuration by the end of their testing period.
Read the detailed description
Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp. The device will interface with research participant's existing prostheses and use the same control strategy that is used for their everyday use. Each participant's prosthesis will be restored to their original configuration by the end of their testing period.
The study will focus on design feasibility testing and will compare performance of hand functional outcome tests on an i-Digits™ prosthetic partial 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 i-Digits™ partial hand prosthesis, 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. Qualitative evaluation will be conducted by an occupational therapist via observation, and by the user through a self-assessment questionnaire, such as the Patient Specific Functional Scale (PSFS). The investigators will be performing repeated measures on each individual subject to reduce the variance as well as having each subject act as their own control. New and existing i-Digits™ partial hand prosthesis users will be recruited for the study and consented with an approved protocol. Research participants will schedule a time to conduct the testing and be informed of study details.
The investigational device being tested is a novel prosthetic finger with a built-in split gripper. The device is an index finger which can drop in place of existing digits on an i-Digits™ partial hand prosthesis. The investigational device is controlled with the same signals as the conventional digits.
This study will pilot test the dexterous fingertip prosthesis with a small number of subjects (up to 12). Research participants will be consented and will test the device at home and/or in-lab. Subjects will be introduced to the partial hand prosthesis configuration and be instructed on how to operate it to complete their testing session.
The in-lab testing will be conducted in a single site visit at Össur Academy in Dublin, Ohio or LTI in Holliston, MA. Subjects may be asked to come back for an additional site visit if data collection is incomplete. For this study, the index finger of each participant's existing everyday prosthesis will be temporarily disconnected and replaced with the investigational device. The prosthesis will be restored to its original configuration when the test session has been completed. 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 i-Digits™ index finger with the investigational device. If comparator, subjects will don their usual unmodified prosthesis. 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 the PSFS survey and subjective questionnaire. Subjects will then doff the prosthesis and don the next device configuration. The PSFS survey as well as user and clinician feedback are both exploratory outcome measures as the design is still in very early prototype stages. The intent of this feedback is to help iterate the design to assist in further development of the final product. Subjects will repeat the functional tests and surveys with each device configuration. After the final condition, the subject will have completed the study and their prosthesis will be restored to its usual configuration. The study session should span 3-5 hours.
A subset of subjects will take home the investigational device for up to 4 weeks to provide feedback of the device when used in everyday tasks. Investigators will restore the user's prosthesis at the end of the testing period and surveys will be conducted to capture feedback. Two site visits may be required: one to initialize the study and configure the prosthesis, and two to restore the prosthesis at the study end. This feedback is also an exploratory outcome measure due to the design being in very early prototype stages.
Both new and existing i-Digits™ partial hand prosthesis users 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: i-Digits™ partial hand prosthesis with dexterous fingertip modification
- Comparator Baseline: unmodified i-Digits™ partial hand prosthesis
Persons with partial hand limb absence who are new or current i-Digits™ prosthesis users will be recruited for this study through the LTI and Össur clinician network. Prosthetists may be contacted with the need for 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 permission to be contacted for future studies may be contacted directly to assess interest in participating in this study. Enrollment will be open to people of all ages, genders, races, and ethnicities. Participants must be new or current users of i-Digits™ partial hand prostheses. The user must have an absent index finger at minimum. Patients who have 4-5 digit and/or thumb involvement will be preferred.
Based on subject population and availability, a convenience sample of up to 12 subjects will be recruited for this pilot study.
- Conditions
- Amputation, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper, Prosthesis User, Upper Limb Amputation at the Hand
- Being tested
- Pointdexter
- Keywords
- amputee, upper limb amputee, partial hand prosthesis user, prosthesis, i-Digits, upper limb loss, prosthetist, gripper, dexterous fingertip, index finger prosthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PointdexterDevice
Also called Dexterous Partial Hand Prosthesis, Gripper
i-Digits partial hand prosthesis modified with the investigational pointdexter finger in place of the usual index finger.
| Study group | Role | What they receive |
|---|---|---|
| Comparator Baseline | No intervention | The subject's usual partial hand prosthesis |
| Pointdexter | Experimental | The subject wears a modified version of their usual partial hand prosthesis. The modification replaces the usual index finger of the partial hand prosthesis with the investigational Pointdexter device. Receives: Device: Pointdexter |
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. The maximum time allotted for each task was 120 seconds, at which point the subject was told to stop the task and the time was reported as the maximum 120 seconds. This test will be used to evaluate the feasibility of the device design as compared with a baseline condition.
This was the only primary outcome measure collected for this study. There were no secondary outcome measures, only exploratory measures as this is a very early prototype design that is still in the design iteration stages.
Measured: 4 hours at a single site visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start15 Jul 2021
- Primary completion28 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Randomised
- Intervention model
- Crossover
- Model description
- Functional tests will be used to evaluate the feasibility of the device design as compared with the subject's baseline device.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liberating Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Össur Iceland ehf
- Responsible party
- Principal investigator, Todd Farrell, Liberating Technologies, Inc.
- Investigators
- Todd Farrell, PhD, Principal investigator, Liberating Technologies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038566
- Sponsor's protocol ID
- 20212193
- Status last verified
- Jan 2025
- First submitted
- 1 Jun 2021
- Last updated
- 17 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexterous Partial Hand Prosthesis Outcomes
- ClinicalTrials.gov ID
- NCT05038566
- Acronym / sponsor ID
- 20212193
- Conditions
- Amputation, Amputation; Traumatic, Hand, Limb; Absence, Congenital, Upper, Prosthesis User, Upper Limb Amputation at the Hand
- Keywords
- amputee, upper limb amputee, partial hand prosthesis user, prosthesis, i-Digits, upper limb loss, prosthetist, gripper
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Liberating Technologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Össur Iceland ehf
- Study start
- 15 Jul 2021 (actual)
- Primary completion
- 28 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 9 Sep 2021 (actual)
- Results
- Posted 17 Jan 2025
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 a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp. The device will interface with research participants' existing prostheses and use the same control strategy that is used for their everyday use. Each participant's prosthesis will be restored to their original configuration by the end of their testing period.
Detailed description
Liberating Technologies, Inc. (LTI) has developed a dexterous prosthetic fingertip that will be fit onto an i-Digits™ partial hand prosthesis and allow for an additional fine grasp. The device will interface with research participant's existing prostheses and use the same control strategy that is used for their everyday use. Each participant's prosthesis will be restored to their original configuration by the end of their testing period.
The study will focus on design feasibility testing and will compare performance of hand functional outcome tests on an i-Digits™ prosthetic partial 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 i-Digits™ partial hand prosthesis, 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. Qualitative evaluation will be conducted by an occupational therapist via observation, and by the user through a self-assessment questionnaire, such as the Patient Specific Functional Scale (PSFS). The investigators will be performing repeated measures on each individual subject to reduce the variance as well as having each subject act as their own control. New and existing i-Digits™ partial hand prosthesis users will be recruited for the study and consented with an approved protocol. Research participants will schedule a time to conduct the testing and be informed of study details.
The investigational device being tested is a novel prosthetic finger with a built-in split gripper. The device is an index finger which can drop in place of existing digits on an i-Digits™ partial hand prosthesis. The investigational device is controlled with the same signals as the conventional digits.
This study will pilot test the dexterous fingertip prosthesis with a small number of subjects (up to 12). Research participants will be consented and will test the device at home and/or in-lab. Subjects will be introduced to the partial hand prosthesis configuration and be instructed on how to operate it to complete their testing session.
The in-lab testing will be conducted in a single site visit at Össur Academy in Dublin, Ohio or LTI in Holliston, MA. Subjects may be asked to come back for an additional site visit if data collection is incomplete. For this study, the index finger of each participant's existing everyday prosthesis will be temporarily disconnected and replaced with the investigational device. The prosthesis will be restored to its original configuration when the test session has been completed. 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 i-Digits™ index finger with the investigational device. If comparator, subjects will don their usual unmodified prosthesis. 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 the PSFS survey and subjective questionnaire. Subjects will then doff the prosthesis and don the next device configuration. The PSFS survey as well as user and clinician feedback are both exploratory outcome measures as the design is still in very early prototype stages. The intent of this feedback is to help iterate the design to assist in further development of the final product. Subjects will repeat the functional tests and surveys with each device configuration. After the final condition, the subject will have completed the study and their prosthesis will be restored to its usual configuration. The study session should span 3-5 hours.
A subset of subjects will take home the investigational device for up to 4 weeks to provide feedback of the device when used in everyday tasks. Investigators will restore the user's prosthesis at the end of the testing period and surveys will be conducted to capture feedback. Two site visits may be required: one to initialize the study and configure the prosthesis, and two to restore the prosthesis at the study end. This feedback is also an exploratory outcome measure due to the design being in very early prototype stages.
Both new and existing i-Digits™ partial hand prosthesis users 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: i-Digits™ partial hand prosthesis with dexterous fingertip modification
- Comparator Baseline: unmodified i-Digits™ partial hand prosthesis
Persons with partial hand limb absence who are new or current i-Digits™ prosthesis users will be recruited for this study through the LTI and Össur clinician network. Prosthetists may be contacted with the need for 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 permission to be contacted for future studies may be contacted directly to assess interest in participating in this study. Enrollment will be open to people of all ages, genders, races, and ethnicities. Participants must be new or current users of i-Digits™ partial hand prostheses. The user must have an absent index finger at minimum. Patients who have 4-5 digit and/or thumb involvement will be preferred.
Based on subject population and availability, a convenience sample of up to 12 subjects will be recruited for this pilot study.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Functional tests will be used to evaluate the feasibility of the device design as compared with the subject's baseline device.
| Arm | Type | Receives |
|---|---|---|
| Comparator Baseline | No intervention | –The subject's usual partial hand prosthesis |
| Pointdexter | Experimental | Device: PointdexterThe subject wears a modified version of their usual partial hand prosthesis. The modification replaces the usual index finger of the partial hand prosthesis with the investigational Pointdexter device. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Must have an upper limb partial hand absence.
- Must be new or current i-Digits prosthesis users.
- Must have an absent index finger at minimum.
- Must be able to understand spoken and written English in order to be properly consented and provide feedback to the study personnel.
- Must be willing and able to complete outlined tasks and provide feedback on the intervention.
Key exclusion criteria (1 listed)
- The risks to pregnant women and fetuses are unknown and therefore pregnant women should not participate in the study.
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 Partial Hand Prosthesis, Gripperi-Digits partial hand prosthesis modified with the investigational pointdexter finger in place of the usual index finger. | Device | Pointdexter |
Primary outcome
Jebsen-Taylor Small Common Objects Functional Test
Time frame: 4 hours at a single site visit
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. The maximum time allotted for each task was 120 seconds, at which point the subject was told to stop the task and the time was reported as the maximum 120 seconds. This test will be used to evaluate the feasibility of the device design as compared with a baseline condition. This was the only primary outcome measure collected for this study. There were no secondary outcome measures, only exploratory measures as this is a very early prototype design that is still in the design iteration stages.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Todd Farrell, PhD principal investigator
Liberating Technologies, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pointdexter in people with Amputation and Amputation; Traumatic, Hand, run by Liberating Technologies, Inc. at 2 sites 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 5 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: finished, as of the sponsor's last update on 17 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 17 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 at a single site visit). 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 17 Jan 2025.