Trial Outcomes & Findings for Dexterous Partial Hand Prosthesis Outcomes (NCT NCT05038566)
NCT ID: NCT05038566
Last Updated: 2025-01-17
Results Overview
During the in-lab portion of the study, subjects will be asked to complete the 'small common objects' subtask of the Jebsen-Taylor Hand Function Test, which assesses a broad range of unimanual hand functions required for ADLs. The primary quantitative measure of the Jebsen-Taylor task will be completion time of each subtask. The maximum time allotted for each task was 120 seconds, at which point the subject was told to stop the task and the time was reported as the maximum 120 seconds. This test will be used to evaluate the feasibility of the device design as compared with a baseline condition. This was the only primary outcome measure collected for this study. There were no secondary outcome measures, only exploratory measures as this is a very early prototype design that is still in the design iteration stages.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
4 hours at a single site visit
Results posted on
2025-01-17
Participant Flow
Participant milestones
| Measure |
Comparator Baseline, Then Pointdexter
The subject wears their usual partial hand prosthesis while performing functional outcome measures. The subject then wears a modified version of their usual partial hand prosthesis. The modification replaces the usual index finger of the partial hand prosthesis with the investigational Pointdexter device. Subjects will test out this hand configuration in the lab while performing functional outcome measures. This testing occurs at a single site visit (1 day) and lasts approximately 4 hours.
Pointdexter: i-Digits partial hand prosthesis modified with the investigational pointdexter finger in place of the usual index finger.
|
Pointdexter, Then Comparator Baseline
The subject wears a modified version of their usual partial hand prosthesis. The modification replaces the usual index finger of the partial hand prosthesis with the investigational Pointdexter device. Subjects will test out this hand configuration in the lab while performing functional outcome measures. The subject then wears their usual partial hand prosthesis while performing functional outcome measures. This testing occurs at a single site visit (1 day) and lasts approximately 4 hours.
Pointdexter: i-Digits partial hand prosthesis modified with the investigational pointdexter finger in place of the usual index finger.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Comparator Baseline, Then Pointdexter
The subject wears their usual partial hand prosthesis while performing functional outcome measures. The subject then wears a modified version of their usual partial hand prosthesis. The modification replaces the usual index finger of the partial hand prosthesis with the investigational Pointdexter device. Subjects will test out this hand configuration in the lab while performing functional outcome measures. This testing occurs at a single site visit (1 day) and lasts approximately 4 hours.
Pointdexter: i-Digits partial hand prosthesis modified with the investigational pointdexter finger in place of the usual index finger.
|
Pointdexter, Then Comparator Baseline
The subject wears a modified version of their usual partial hand prosthesis. The modification replaces the usual index finger of the partial hand prosthesis with the investigational Pointdexter device. Subjects will test out this hand configuration in the lab while performing functional outcome measures. The subject then wears their usual partial hand prosthesis while performing functional outcome measures. This testing occurs at a single site visit (1 day) and lasts approximately 4 hours.
Pointdexter: i-Digits partial hand prosthesis modified with the investigational pointdexter finger in place of the usual index finger.
|
|---|---|---|
|
Overall Study
Technical Difficulties with the Device
|
0
|
1
|
Baseline Characteristics
Dexterous Partial Hand Prosthesis Outcomes
Baseline characteristics by cohort
| Measure |
Comparator Baseline, Then Pointdexter (~4 Hours of In-lab Testing)
n=2 Participants
The subject wears their usual partial hand prosthesis while performing functional outcome measures. The subject then wears a modified version of their usual partial hand prosthesis. The modification replaces the usual index finger of the partial hand prosthesis with the investigational Pointdexter device. Subjects will either test out this hand configuration in the lab while performing functional outcome measures.
The subject may then choose to take home the Pointdexter device for up to 4 weeks for feasibility testing of the early stage prototype device.
Pointdexter: i-Digits partial hand prosthesis modified with the investigational pointdexter finger in place of the usual index finger.
|
Pointdexter, Then Comparator Baseline (~4 Hours of In-lab Testing)
n=2 Participants
The subject wears a modified version of their usual partial hand prosthesis. The modification replaces the usual index finger of the partial hand prosthesis with the investigational Pointdexter device. Subjects will test out this hand configuration in the lab while performing functional outcome measures. The subject then wears their usual partial hand prosthesis while performing functional outcome measures.
The subject may then choose to take home the Pointdexter device for up to 4 weeks for feasibility testing of the early stage prototype device.
Pointdexter: i-Digits partial hand prosthesis modified with the investigational pointdexter finger in place of the usual index finger.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 hours at a single site visitPopulation: One participant was excluded from analysis due to an incomplete session because of technical difficulties with the device
During the in-lab portion of the study, subjects will be asked to complete the 'small common objects' subtask of the Jebsen-Taylor Hand Function Test, which assesses a broad range of unimanual hand functions required for ADLs. The primary quantitative measure of the Jebsen-Taylor task will be completion time of each subtask. The maximum time allotted for each task was 120 seconds, at which point the subject was told to stop the task and the time was reported as the maximum 120 seconds. This test will be used to evaluate the feasibility of the device design as compared with a baseline condition. This was the only primary outcome measure collected for this study. There were no secondary outcome measures, only exploratory measures as this is a very early prototype design that is still in the design iteration stages.
Outcome measures
| Measure |
Comparator Baseline
n=2 Participants
The subject wears their usual partial hand prosthesis while performing functional outcome measures. Subjects will test out this hand configuration in the lab while performing functional outcome measures. This testing occurs at a single site visit (1 day) and lasts approximately 4 hours.
|
Pointdexter
n=1 Participants
The subject wears a modified version of their usual partial hand prosthesis. The modification replaces the usual index finger of the partial hand prosthesis with the investigational Pointdexter device. Subjects will test out this hand configuration in the lab while performing functional outcome measures. This testing occurs at a single site visit (1 day) and lasts approximately 4 hours.
Pointdexter: i-Digits partial hand prosthesis modified with the investigational pointdexter finger in place of the usual index finger.
|
|---|---|---|
|
Jebsen-Taylor Small Common Objects Functional Test
Large Light Objects
|
11.7 Seconds
Standard Deviation 4.2
|
14.3 Seconds
Standard Deviation 3.7
|
|
Jebsen-Taylor Small Common Objects Functional Test
Turning a Card Over
|
34.8 Seconds
Standard Deviation 20.5
|
26.1 Seconds
Standard Deviation 4.5
|
|
Jebsen-Taylor Small Common Objects Functional Test
Small Common Objects
|
97.2 Seconds
Standard Deviation 32.2
|
62.1 Seconds
Standard Deviation 2.2
|
|
Jebsen-Taylor Small Common Objects Functional Test
Stacking Checkers
|
37.5 Seconds
Standard Deviation 43.1
|
28 Seconds
Standard Deviation 21.8
|
|
Jebsen-Taylor Small Common Objects Functional Test
Manipulating Cloth
|
5.4 Seconds
Standard Deviation 1.5
|
5.8 Seconds
Standard Deviation 1.7
|
|
Jebsen-Taylor Small Common Objects Functional Test
Holding a Screw
|
24.1 Seconds
Standard Deviation 1.8
|
65.7 Seconds
Standard Deviation 34.7
|
|
Jebsen-Taylor Small Common Objects Functional Test
9-Hole Out
|
11.4 Seconds
Standard Deviation 8.1
|
23.3 Seconds
Standard Deviation 19
|
|
Jebsen-Taylor Small Common Objects Functional Test
9-Hole In
|
120 Seconds
Standard Deviation 0
|
63.8 Seconds
Standard Deviation 57.3
|
|
Jebsen-Taylor Small Common Objects Functional Test
Removing Pen Cap
|
5.8 Seconds
Standard Deviation 2.3
|
7.1 Seconds
Standard Deviation 4.2
|
|
Jebsen-Taylor Small Common Objects Functional Test
Tying Shoe Laces
|
50.5 Seconds
Standard Deviation 49
|
34.6 Seconds
Standard Deviation 1.1
|
|
Jebsen-Taylor Small Common Objects Functional Test
Zipping a Zipper
|
32.6 Seconds
Standard Deviation 10.2
|
120 Seconds
Standard Deviation 0
|
|
Jebsen-Taylor Small Common Objects Functional Test
Threading a Needle
|
120 Seconds
Standard Deviation 0
|
32.4 Seconds
Standard Deviation 8.1
|
|
Jebsen-Taylor Small Common Objects Functional Test
Simulated Feeding
|
30.1 Seconds
Standard Deviation 22
|
66.3 Seconds
Standard Deviation 76
|
|
Jebsen-Taylor Small Common Objects Functional Test
Large Heavy Objects
|
17.8 Seconds
Standard Deviation 4.6
|
16.7 Seconds
Standard Deviation 5
|
Adverse Events
Comparator Baseline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pointdexter
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