Trial Outcomes & Findings for Wireless Prosthetic Control Effectiveness Study (NCT NCT06821412)
NCT ID: NCT06821412
Last Updated: 2025-11-04
Results Overview
The Orthotics and Prosthetics User's Survey (OPUS) is a self-report questionnaire consisting of five modules. The version of the OPUS which will be administered consists of 9 questions in 1 category (satisfaction with device). Questions are asked and scored on a scale from 0-4 (0=strongly disagree, 1=disagree, 2=neither agree nor disagree, 3=agree, and 4=strongly agree), with a higher value indicating a better outcome. There is an additional response for "Don't know / Not Applicable", which if chosen, is not included in the scoring. This survey will be given at the end of each study condition (2 conditions, 1 month per condition). Analysis is reported as a value that calculates the average of all questions (sum up all questions and divide by total number of questions).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
At the end of each 1 month condition
Results posted on
2025-11-04
Participant Flow
Participant milestones
| Measure |
Wireless Control, Then Wired Control
The participant wears the experimental socket in the wireless configuration using the prototype ASTERISK system connected within the electronics of the prosthetic socket. Then the participant wears the experimental socket in the wired configuration, which mimics the current setup for EMG-controlled prostheses The electronics are not accessible by the participant which allows both configurations to be blinded to the participants.
ASTERISK System: This intervention uses an experimental socket fabricated by a certified prosthetist. The electronics within the experimental socket are set up with the ASTERISK system, which sends information collected from the EMG sensors to the prosthetic hand wirelessly rather than the current available method of wired control.
Wired Configuration: This intervention uses the same experimental socket that is used for the ASTERISK intervention. The prosthesis is set-up with wired EMG control, which is the current available method for EMG-controlled prostheses.
|
Wired Control, Then Wireless Control
The participant wears the experimental socket in the wired configuration, which mimics the current setup for EMG-controlled prostheses. Then the participant wears the experimental socket in the wireless configuration using the prototype ASTERISK system connected within the electronics of the prosthetic socket. The electronics are not accessible by the participant which allows both configurations to be blinded to the participants.
ASTERISK System: This intervention uses an experimental socket fabricated by a certified prosthetist. The electronics within the experimental socket are set up with the ASTERISK system, which sends information collected from the EMG sensors to the prosthetic hand wirelessly rather than the current available method of wired control.
Wired Configuration: This intervention uses the same experimental socket that is used for the ASTERISK intervention. The prosthesis is set-up with wired EMG control, which is the current available method for EMG-controlled prostheses.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
|
Overall Study
COMPLETED
|
3
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Wireless Prosthetic Control Effectiveness Study
Baseline characteristics by cohort
| Measure |
Wireless Control, Then Wired Control
n=3 Participants
The participant wears the experimental socket in the wireless configuration using the prototype ASTERISK system connected within the electronics of the prosthetic socket. Then the participant wears the experimental socket in the wired configuration, which mimics the current setup for EMG-controlled prostheses The electronics are not accessible by the participant which allows both configurations to be blinded to the participants.
ASTERISK System: This intervention uses an experimental socket fabricated by a certified prosthetist. The electronics within the experimental socket are set up with the ASTERISK system, which sends information collected from the EMG sensors to the prosthetic hand wirelessly rather than the current available method of wired control.
Wired Configuration: This intervention uses the same experimental socket that is used for the ASTERISK intervention. The prosthesis is set-up with wired EMG control, which is the current available method for EMG-controlled prostheses.
|
Wired Control, Then Wireless Control
n=1 Participants
The participant wears the experimental socket in the wired configuration, which mimics the current setup for EMG-controlled prostheses. Then the participant wears the experimental socket in the wireless configuration using the prototype ASTERISK system connected within the electronics of the prosthetic socket. The electronics are not accessible by the participant which allows both configurations to be blinded to the participants.
ASTERISK System: This intervention uses an experimental socket fabricated by a certified prosthetist. The electronics within the experimental socket are set up with the ASTERISK system, which sends information collected from the EMG sensors to the prosthetic hand wirelessly rather than the current available method of wired control.
Wired Configuration: This intervention uses the same experimental socket that is used for the ASTERISK intervention. The prosthesis is set-up with wired EMG control, which is the current available method for EMG-controlled prostheses.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=15 Participants
|
1 participants
n=161 Participants
|
4 participants
n=100 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
3 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
1 Participants
n=100 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
2 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
4 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=15 Participants
|
1 Participants
n=161 Participants
|
4 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=15 Participants
|
0 Participants
n=161 Participants
|
0 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: At the end of each 1 month conditionPopulation: 4 total participants enrolled, 4 total completed each condition
The Orthotics and Prosthetics User's Survey (OPUS) is a self-report questionnaire consisting of five modules. The version of the OPUS which will be administered consists of 9 questions in 1 category (satisfaction with device). Questions are asked and scored on a scale from 0-4 (0=strongly disagree, 1=disagree, 2=neither agree nor disagree, 3=agree, and 4=strongly agree), with a higher value indicating a better outcome. There is an additional response for "Don't know / Not Applicable", which if chosen, is not included in the scoring. This survey will be given at the end of each study condition (2 conditions, 1 month per condition). Analysis is reported as a value that calculates the average of all questions (sum up all questions and divide by total number of questions).
Outcome measures
| Measure |
Wireless Control
n=4 Participants
The participant wears the experimental socket in the wireless configuration using the prototype ASTERISK system connected within the electronics of the prosthetic socket. The electronics are not accessible by the participant which allows both configurations to be blinded to the participants.
ASTERISK System: This intervention uses an experimental socket fabricated by a certified prosthetist. The electronics within the experimental socket are set up with the ASTERISK system, which sends information collected from the EMG sensors to the prosthetic hand wirelessly rather than the current available method of wired control.
|
Wired Control
n=4 Participants
The participant wears the experimental socket in the wired configuration, which mimics the current setup for EMG-controlled prostheses. The electronics are not accessible by the participant which allows both configurations to be blinded to the participants.
Wired Configuration: This intervention uses the same experimental socket that is used for the ASTERISK intervention. The prosthesis is set-up with wired EMG control, which is the current available method for EMG-controlled prostheses.
|
|---|---|---|
|
Orthotics and Prosthetics User Survey - Satisfaction With Device (OPUS-SD)
|
2.89 score on a scale
Standard Deviation 0.94
|
3.11 score on a scale
Standard Deviation 0.77
|
Adverse Events
Wireless Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Wired 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