An interventional study of Semi-autonomous myoelectric control algorithm and Standard-of-care myoelectric control algorithm in Amputation; Traumatic, Arm, Upper, sponsored by Point Designs. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Point Designs · Not applicable, Interventional, and Device feasibility
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.
112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.
This study's enrollment of 11 is below the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →Point Designs is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
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Exclusion Criteria:
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.
Device: Semi-autonomous myoelectric control algorithm · Device: Standard-of-care myoelectric control algorithm
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
Device: Semi-autonomous myoelectric control algorithm · Device: Standard-of-care myoelectric control algorithm
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.
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.
Time frame: Day 1 (1 hour)
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.
Time frame: Day 1 (1 hour)
| Milestone | Standard-of-care Then Semi-autonomous Myoelectric Control | Semi-autonomous Then Standard-of-care Myoelectric Control |
|---|---|---|
| Started | 7 | 4 |
| Completed | 7 | 4 |
| Not completed | 0 | 0 |
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.
| percentage of attempted transfers | Standard-of-care Then Semi-autonomous Myoelectric Control | Semi-autonomous Then Standard-of-care Myoelectric Control |
|---|---|---|
| Standard-of-care control | 67.50 ± 20.35 | 72.75 ± 17.54 |
| Semi-autonomous control | 93.46 ± 9.02 | 95.06 ± 6.93 |
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.
| ball drops | Standard-of-care Then Semi-autonomous Myoelectric Control | Semi-autonomous Then Standard-of-care Myoelectric Control |
|---|---|---|
| Standard-of-care control | 0 (0 to 1) | 0 (0 to 1) |
| Semi-autonomous control | 1 (0 to 2) | 0 (0 to 2) |
Collected over 9 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard-of-care Then Semi-autonomous Myoelectric Control | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Semi-autonomous Then Standard-of-care Myoelectric Control | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | Standard-of-care Then Semi-autonomous Myoelectric Control | Semi-autonomous Then Standard-of-care Myoelectric Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 7 | 4 | 11 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Standard-of-care Then Semi-autonomous Myoelectric Control | Semi-autonomous Then Standard-of-care Myoelectric Control | Total |
|---|---|---|---|
| Mean | 30 ± 7 | 27 ± 1 | 29 ± 6 |
| Sex: Female, Male(Participants) | Standard-of-care Then Semi-autonomous Myoelectric Control | Semi-autonomous Then Standard-of-care Myoelectric Control | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 5 | 3 | 8 |
| Race and Ethnicity Not Collected(Participants) | Standard-of-care Then Semi-autonomous Myoelectric Control | Semi-autonomous Then Standard-of-care Myoelectric Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Standard-of-care Then Semi-autonomous Myoelectric Control | Semi-autonomous Then Standard-of-care Myoelectric Control | Total |
|---|---|---|---|
| United States | 7 | 4 | 14 |
| Handedness(Participants) | Standard-of-care Then Semi-autonomous Myoelectric Control | Semi-autonomous Then Standard-of-care Myoelectric Control | Total |
|---|---|---|---|
| Right | 6 | 3 | 9 |
| Left | 1 | 1 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
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