N/A
N=11
Teleoperation Experimental Comparison With Able-bodied Subjects
Amputation; Traumatic, Arm, Upper
Bottom Line
View on ClinicalTrials.gov: NCT05048394 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Dec 2024
Primary outcome: Primary: Transfer Success Rate in a Fragile Box and Blocks Task — 67.50; 72.75; 93.46; 95.06 percentage of attempted transfers — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Semi-autonomous myoelectric control algorithm (Device); Standard-of-care myoelectric control algorithm (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Point Designs
- Primary completion
- Jul 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Transfer Success Rate in a Fragile Box and Blocks Task |
67.50; 72.75; 93.46; 95.06 | <0.001 sig |
| SECONDARY Ball Drops in a Holding Task |
0; 0; 1; 0 | 0.14 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05048394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.