Amputation; Traumatic, Arm, Upper
Conditions
Brief 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. 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.
Interventions
DEVICESemi-autonomous myoelectric control algorithm
The semi-autonomous myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.
DEVICEStandard-of-care myoelectric control algorithm
The standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.
Sponsors
University of Colorado, Boulder
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Point Designs
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Able-bodied subject * Fluent in English * Age of 18 years or greater
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transfer Success Rate in a Fragile Box and Blocks Task | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ball Drops in a Holding Task | Day 1 (1 hour) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard-of-care Then Semi-autonomous Myoelectric Control 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.
Semi-autonomous myoelectric control algorithm: 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 algorithm: The standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand. | 7 |
| Semi-autonomous Then Standard-of-care Myoelectric Control 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
Semi-autonomous myoelectric control algorithm: 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 algorithm: The standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand. | 4 |
| Total | 11 |
Baseline characteristics
| Characteristic | Standard-of-care Then Semi-autonomous Myoelectric Control | Semi-autonomous Then Standard-of-care Myoelectric Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 4 Participants | 11 Participants |
| Age, Continuous | 30 years STANDARD_DEVIATION 7 | 27 years STANDARD_DEVIATION 1 | 29 years STANDARD_DEVIATION 6 |
| Handedness Left | 1 Participants | 1 Participants | 2 Participants |
| Handedness Right | 6 Participants | 3 Participants | 9 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 7 participants | 4 participants | 14 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 5 Participants | 3 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 4 |
| other Total, other adverse events | 0 / 7 | 0 / 4 |
| serious Total, serious adverse events | 0 / 7 | 0 / 4 |
Outcome results
Primary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard-of-care Then Semi-autonomous Myoelectric Control | Transfer Success Rate in a Fragile Box and Blocks Task | Standard-of-care control | 67.50 percentage of attempted transfers | Standard Deviation 20.35 |
| Standard-of-care Then Semi-autonomous Myoelectric Control | Transfer Success Rate in a Fragile Box and Blocks Task | Semi-autonomous control | 93.46 percentage of attempted transfers | Standard Deviation 9.02 |
| Semi-autonomous Then Standard-of-care Myoelectric Control | Transfer Success Rate in a Fragile Box and Blocks Task | Semi-autonomous control | 95.06 percentage of attempted transfers | Standard Deviation 6.93 |
| Semi-autonomous Then Standard-of-care Myoelectric Control | Transfer Success Rate in a Fragile Box and Blocks Task | Standard-of-care control | 72.75 percentage of attempted transfers | Standard Deviation 17.54 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
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)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Standard-of-care Then Semi-autonomous Myoelectric Control | Ball Drops in a Holding Task | Standard-of-care control | 0 ball drops |
| Standard-of-care Then Semi-autonomous Myoelectric Control | Ball Drops in a Holding Task | Semi-autonomous control | 1 ball drops |
| Semi-autonomous Then Standard-of-care Myoelectric Control | Ball Drops in a Holding Task | Standard-of-care control | 0 ball drops |
| Semi-autonomous Then Standard-of-care Myoelectric Control | Ball Drops in a Holding Task | Semi-autonomous control | 0 ball drops |
p-value: 0.14Wilcoxon (Mann-Whitney)