Trial Outcomes & Findings for Hand Function for Tetraplegia (NCT NCT00890916)
NCT ID: NCT00890916
Last Updated: 2021-06-09
Results Overview
Grasp and Release Test (GRT) - The Grasp and Release Test (GRT) \[Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004\], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers \[Peckham, 2001\]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (\~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds.
COMPLETED
NA
10 participants
6-9 weeks
2021-06-09
Participant Flow
Note that the data from the first three (of 10) participants was published in the Journal of Hand Surgery (2008; 33(4):539-50).
Participant milestones
| Measure |
Neuroprosthesis System
Subjects who have undergone implantation of the neuroprosthesis system known as the FIRSTHAND/IST-12 System.
|
|---|---|
|
Rehab - Neuroprosthesis (NP) "On"
STARTED
|
10
|
|
Rehab - Neuroprosthesis (NP) "On"
Grasp Release Pre-Test "ON"
|
10
|
|
Rehab - Neuroprosthesis (NP) "On"
COMPLETED
|
10
|
|
Rehab - Neuroprosthesis (NP) "On"
NOT COMPLETED
|
0
|
|
Rehab - NP "Off"
STARTED
|
10
|
|
Rehab - NP "Off"
Grasp Release Pre-Test "OFF"
|
10
|
|
Rehab - NP "Off"
COMPLETED
|
10
|
|
Rehab - NP "Off"
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Hand Function for Tetraplegia
Baseline characteristics by cohort
| Measure |
Neuroprosthesis System
n=10 Participants
Receives implanted device for hand function.
FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels. Also known as the "IST-12" System.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Grasp-Release Test
|
2 Number of Completions
n=99 Participants
|
PRIMARY outcome
Timeframe: 6-9 weeksGrasp and Release Test (GRT) - The Grasp and Release Test (GRT) \[Wuolle, 1994; Smith et al., 1996; Carroll et al., 2000; Taylor et al., 2002; Mulcahey et al., 2004\], developed at the Cleveland FES Center, has been utilized by multiple centers to show improvements in hand function after implantation of a neuroprosthesis and tendon transfers \[Peckham, 2001\]. This pick-and-place test requires the participant to unilaterally acquire, move, and release six objects varying in weight and size. The objects are: 1) a small peg, 2) a wooden cube, 3) a small juice can, 4) a videotape, 5) a paperweight (\~1000g) and a simulated fork task (spring-loaded plunger). The number of objects that the participant can successfully manipulate are scored. Success in manipulating each object in the GRT is defined as the ability to pick up and place the object at least once within 30 seconds.
Outcome measures
| Measure |
Neuroprosthesis System
n=10 Participants
Subjects with the implanted FIRSTHAND/IST-12 System.
|
|---|---|
|
Grasp Release Test - Test of Functional Ability to Pick up and Move Objects
Rehab - NP "OFF"
|
2 Number of Completions
Interval 0.0 to 4.0
|
|
Grasp Release Test - Test of Functional Ability to Pick up and Move Objects
Rehab - NP "ON"
|
5.5 Number of Completions
Interval 5.0 to 6.0
|
Adverse Events
Neuroprosthesis System
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Neuroprosthesis System
n=10 participants at risk
Receives implanted device for hand function.
FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels.
|
|---|---|
|
Infections and infestations
Device Infection
|
20.0%
2/10 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place