Amputation; Traumatic, Arm, UpperNCT05048394
Teleoperation Experimental Comparison With Able-bodied Subjects
A study of Amputation; Traumatic, Arm, Upper, run by Point Designs at 1 site in United States.
Trial summary
To compare the use of the semi-autonomous control algorithm (condition 1) with the standard of care myoelectric system used with the TASKA prosthetic hand (condition 2). Able bodied subjects will enroll in a laboratory based experimental session at the University of Colorado at Boulder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Amputation; Traumatic, Arm, Upper
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 31 Jul 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able-bodied subject
- Fluent in English
- Age of 18 years or greater
Who cannot join
- Significant cognitive deficits as determined upon clinical evaluation
- Significant neurological deficits as determined upon clinical evaluation
- Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Boulder
Boulder, Colorado, 80309
About this study
To compare the use of the semi-autonomous control algorithm (condition 1) with the standard of care myoelectric system used with the TASKA prosthetic hand (condition 2). Able bodied subjects will enroll in a laboratory based experimental session at the University of Colorado at Boulder. Subjects will be fitted with a by-pass prosthesis which enables the able-bodied subject to control the prosthetic hand using the myoelectric signals on their able limb. A TASKA prosthetic hand will be sensorized using the Point Touch technology. In a randomized order, the subjects will perform functional tasks evaluating dexterity and assistance with prolonged gross motor movement using each experimental condition. Then, a direct comparison can be made across subjects for the semi-autonomous control algorithm and the standard of care myoelectric system used in the TASKA prosthetic hand.
- Conditions
- Amputation; Traumatic, Arm, Upper
- Being tested
- Semi-autonomous myoelectric control algorithm, Standard-of-care myoelectric control algorithm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-autonomous myoelectric control algorithmDevice
The semi-autonomous myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.
Standard-of-care myoelectric control algorithmDevice
The standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.
| Study group | Role | What they receive |
|---|---|---|
| Standard-of-care then Semi-autonomous myoelectric control | Experimental | The standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand
The semi-autonomous myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand. Receives: Device: Semi-autonomous myoelectric control algorithm; Device: Standard-of-care myoelectric control algorithm |
| Semi-autonomous then Standard-of-care myoelectric control | Experimental | The semi-autonomous myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.
The standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand Receives: Device: Semi-autonomous myoelectric control algorithm; Device: Standard-of-care myoelectric control algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfer Success Rate in a Fragile Box and Blocks Task
The participant is instructed to transfer a fragile, ball-like object that breaks at 8 Newtons of force over a 10-centimeter high barrier as many times as possible in a 2-minute period. A broken or dropped object is considered an unsuccessful transfer. The number of successful and attempted transfers is recorded. This task is modeled after the Box-and-Blocks Test and has been used to validate fine dexterity of myoelectric upper limb prostheses.
Measured: Day 1 (1 hour)
Secondary outcomes (1)
Ball Drops in a Holding Task
The participant is instructed to pick up a 2-inch Styrofoam ball and hold the object above the desk or table for 2 minutes. If the ball is dropped, the participant is instructed to pick it back up. The 2-minute timer does not restart. The number of times the ball was dropped is recorded. This task has been used to validate the ability of myoelectric prostheses to assist with gross, prolonged movements.
Measured: Day 1 (1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Mar 2022
- Primary completion31 Jul 2023
- Study completion31 Jul 2023
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 Amputation; Traumatic, Arm, UpperStudies 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
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Point Designs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Colorado, Boulder, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048394
- Sponsor's protocol ID
- 377394
- Other IDs
- R41EB032723
- Status last verified
- Dec 2024
- First submitted
- 8 Sep 2021
- Last updated
- 18 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teleoperation Experimental Comparison With Able-bodied Subjects
- ClinicalTrials.gov ID
- NCT05048394
- Acronym / sponsor ID
- 377394
- Conditions
- Amputation; Traumatic, Arm, Upper
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Point DesignsIndustry (pharma, biotech, devices)
- Collaborators
- University of Colorado, Boulder, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 17 Sep 2021 (actual)
- Results
- Posted 18 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the use of the semi-autonomous control algorithm (condition 1) with the standard of care myoelectric system used with the TASKA prosthetic hand (condition 2). Able bodied subjects will enroll in a laboratory based experimental session at the University of Colorado at Boulder. Subjects will be fitted with a by-pass prosthesis which enables the able-bodied subject to control the prosthetic hand using the myoelectric signals on their able limb. A TASKA prosthetic hand will be sensorized using the Point Touch technology. In a randomized order, the subjects will perform functional tasks evaluating dexterity and assistance with prolonged gross motor movement using each experimental condition. Then, a direct comparison can be made across subjects for the semi-autonomous control algorithm and the standard of care myoelectric system used in the TASKA prosthetic hand.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard-of-care then Semi-autonomous myoelectric control | Experimental | Device: Semi-autonomous myoelectric control algorithm, Device: Standard-of-care myoelectric control algorithmThe standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand The semi-autonomous myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand. |
| Semi-autonomous then Standard-of-care myoelectric control | Experimental | Device: Semi-autonomous myoelectric control algorithm, Device: Standard-of-care myoelectric control algorithmThe semi-autonomous myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand. The standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able-bodied subject
- Fluent in English
- Age of 18 years or greater
Key exclusion criteria (3 listed)
- Significant cognitive deficits as determined upon clinical evaluation
- Significant neurological deficits as determined upon clinical evaluation
- Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
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 |
|---|---|---|
| Semi-autonomous myoelectric control algorithmThe semi-autonomous myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand. | Device | Semi-autonomous then Standard-of-care myoelectric control, Standard-of-care then Semi-autonomous myoelectric control |
| Standard-of-care myoelectric control algorithmThe standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand. | Device | Semi-autonomous then Standard-of-care myoelectric control, Standard-of-care then Semi-autonomous myoelectric control |
Primary outcome
Transfer Success Rate in a Fragile Box and Blocks Task
Time frame: Day 1 (1 hour)
The participant is instructed to transfer a fragile, ball-like object that breaks at 8 Newtons of force over a 10-centimeter high barrier as many times as possible in a 2-minute period. A broken or dropped object is considered an unsuccessful transfer. The number of successful and attempted transfers is recorded. This task is modeled after the Box-and-Blocks Test and has been used to validate fine dexterity of myoelectric upper limb prostheses.
1 secondary outcome
Ball Drops in a Holding Task
Time frame: Day 1 (1 hour)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- 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.
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 of Amputation; Traumatic, Arm, Upper, run by Point Designs 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: finished, as of the sponsor's last update on 18 Dec 2024. 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?
Yes. Results are posted in the registry (first posted 18 Dec 2024). 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?
Transfer Success Rate in a Fragile Box and Blocks Task (time frame: Day 1 (1 hour)). 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 18 Dec 2024.