Trial Outcomes & Findings for Functional Performance of Voluntary Opening and Closing Body Powered Prostheses (NCT NCT02136238)
NCT ID: NCT02136238
Last Updated: 2023-12-28
Results Overview
Distance sternum is displaced while folding a towel was measured in meters.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.
Results posted on
2023-12-28
Participant Flow
Participant milestones
| Measure |
Voluntary Open Device First Then Voluntary Close Device
Voluntary open device (Hosmer 5X hook terminal device) first then voluntary close device (TRS Grip 3 terminal device)
|
Voluntary Close Device First Then Voluntary Open Device
Voluntary close device (TRS Grip 3 terminal device) first then voluntary open device (Hosmer 5X hook terminal device)
|
Non-amputee Controls
This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
No intervention. Control group.: There are no interventions in this observational arm of the study.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
10
|
|
Overall Study
COMPLETED
|
4
|
4
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Functional Performance of Voluntary Opening and Closing Body Powered Prostheses
Baseline characteristics by cohort
| Measure |
Non-amputee Control Group
n=10 Participants
non-amputee healthy controls
|
Experimental Group: Unilateral TR or Wrist-disartic Amputees
n=8 Participants
Includes groups randomized to receive either TRS Grip 3 voluntary close device or Hosmer 5XA voluntary open device first.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.6 years
STANDARD_DEVIATION 6.0 • n=5 Participants
|
56.1 years
STANDARD_DEVIATION 10.4 • n=7 Participants
|
39.9 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
8 participants
n=7 Participants
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.Distance sternum is displaced while folding a towel was measured in meters.
Outcome measures
| Measure |
Prosthetic Hand 1 (Hosmer 5XA)
n=8 Participants
This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
Hosmer 5XA voluntary opening hook: Voluntary opening prosthetic terminal device ("hand")
|
Prosthetic Hand 2 (TRS Grip 3)
n=8 Participants
This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
TRS Grip 3 voluntary closing hook: Voluntary closing prosthetic terminal device ("hand")
|
Non-amputee Controls
n=10 Participants
This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
|
|---|---|---|---|
|
Sternal Displacement During Towel Folding Task
|
1.0 meters
Standard Deviation 0.13
|
1.06 meters
Standard Deviation 0.12
|
0.88 meters
Standard Deviation 0.18
|
PRIMARY outcome
Timeframe: Based on preliminary experience with the intervention, accommodation can range from 1 month to 2 months. Assessment was scheduled within 1-2 weeks following accommodation.Simulation of 10 activities of daily living (i.e. donning a shirt, sweeping, walking stairs). Measured in units of time, distance and mass to provide a singular, continuous scaled score of function (from 0-100). A score of 100 is the maximal score and indicates the highest level of independent function where a score of 0 indicates the poorest score. Persons scoring lower scores will likely be at increased risk of dependency with daily function.
Outcome measures
| Measure |
Prosthetic Hand 1 (Hosmer 5XA)
n=8 Participants
This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
Hosmer 5XA voluntary opening hook: Voluntary opening prosthetic terminal device ("hand")
|
Prosthetic Hand 2 (TRS Grip 3)
n=8 Participants
This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
TRS Grip 3 voluntary closing hook: Voluntary closing prosthetic terminal device ("hand")
|
Non-amputee Controls
n=10 Participants
This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
|
|---|---|---|---|
|
Physical Function Performance 10 Test Score
|
39.1 units on a scale
Standard Deviation 13.5
|
37.0 units on a scale
Standard Deviation 18.3
|
68.1 units on a scale
Standard Deviation 14.2
|
Adverse Events
Voluntary Open (Hosmer 5XA)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Voluntary Close (TRS Grip 3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-amputee Controls
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