Trial Outcomes & Findings for Teleoperation Experimental Comparison With Able-bodied Subjects (NCT NCT05048394)
NCT ID: NCT05048394
Last Updated: 2024-12-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
11 participants
Primary outcome timeframe
Day 1 (1 hour)
Results posted on
2024-12-18
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
4
|
|
Overall Study
COMPLETED
|
7
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard-of-care Then Semi-autonomous Myoelectric Control
n=7 Participants
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.
|
Semi-autonomous Then Standard-of-care Myoelectric Control
n=4 Participants
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.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=7 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=11 Participants
|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 7 • n=7 Participants
|
27 years
STANDARD_DEVIATION 1 • n=4 Participants
|
29 years
STANDARD_DEVIATION 6 • n=11 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=7 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=7 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
4 participants
n=4 Participants
|
14 participants
n=11 Participants
|
|
Handedness
Right
|
6 Participants
n=7 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=11 Participants
|
|
Handedness
Left
|
1 Participants
n=7 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard-of-care Then Semi-autonomous Myoelectric Control
n=7 Participants
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.
|
Semi-autonomous Then Standard-of-care Myoelectric Control
n=4 Participants
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.
|
|---|---|---|
|
Transfer Success Rate in a Fragile Box and Blocks Task
Standard-of-care control
|
67.50 percentage of attempted transfers
Standard Deviation 20.35
|
72.75 percentage of attempted transfers
Standard Deviation 17.54
|
|
Transfer Success Rate in a Fragile Box and Blocks Task
Semi-autonomous control
|
93.46 percentage of attempted transfers
Standard Deviation 9.02
|
95.06 percentage of attempted transfers
Standard Deviation 6.93
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard-of-care Then Semi-autonomous Myoelectric Control
n=7 Participants
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.
|
Semi-autonomous Then Standard-of-care Myoelectric Control
n=4 Participants
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.
|
|---|---|---|
|
Ball Drops in a Holding Task
Standard-of-care control
|
0 ball drops
Interval 0.0 to 1.0
|
0 ball drops
Interval 0.0 to 1.0
|
|
Ball Drops in a Holding Task
Semi-autonomous control
|
1 ball drops
Interval 0.0 to 2.0
|
0 ball drops
Interval 0.0 to 2.0
|
Adverse Events
Standard-of-care Then Semi-autonomous Myoelectric Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Semi-autonomous Then Standard-of-care Myoelectric Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place