|- candidate number||26942|
|- NTR Number||NTR6504|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-mrt-2017|
|- Secondary IDs||2014.02.28_1 ECB |
|- Public Title||Transfer from a serious game developed to train multi-articulated prosthesis use to actual multi-articulated prosthesis use.|
|- Scientific Title||Examining transfer of a skill trained in two virtual environments with different feedback on performance, to actual use of a myoelectrically controlled hand prosthesis with a specific focus on the ability of switching between grip modes and proportional control of the signal.|
|- hypothesis||The current study focusses on 1) transfer of a skill trained in two virtual environments with different feedback on actual performance to performance with a myoelectrically controlled hand prosthesis, 2) comparing the ability of switching with the ability to proportionally control the signal after a period of training, 3) establish whether individual differences show up in switching ability.|
|- Healt Condition(s) or Problem(s) studied||Healthy subjects, Amputees, Prothesis|
|- Inclusion criteria||The subjects included in this study are able bodied and right handed, with normal or corrected to normal vision. Both male and female subject will be included. All subjects included will be between 18 and 50 years of age.|
|- Exclusion criteria||Subjects with (history of) pain or musculoskeletal impairments of the arms or upper body will not be included. The same accounts for subjects with prior experience in the use of myoelectric devices and subjects younger than 18 or older than 50.|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||3-apr-2017|
|- planned closingdate||31-aug-2017|
|- Target number of participants||40|
|- Interventions||This study is set up with a pre- posttest design with a 5 day training period in between. The participants will be divided into four groups. Depending on the group they will train with either a serious game mimicking a virtual reality setting, a displayed EMG signal on a screen, or a prosthesis simulator. All three devices are controlled using surface EMG measured on the flexor and extensor of the wrist. The fourth group will train with the serious game of the first group but this game will now be controlled using a computer keyboard and touchpad. |
Per day all training sessions will take 15 minutes. During the pre- and posttest all subjects will perform a Clothespin task executed with a prosthesis simulator.
|- Primary outcome||Primary outcome measure per test part; |
Proportional: the error between required and produced velocity and the difference between the aperture of the virtual gripper and the diameter of three differently sized virtual balls.
Discrete: Number of unsuccessful and successful switches, time needed to produce switch, and the type of command signal used to switch (hold-open, co-contraction, double puls).
Displayed EMG signal:
Proportional: The velocities of the left/right movement of a virtual platform at three different speeds (slow, intermediate and fast). The angle of the regression line through the three velocities will be determined.
Discrete: Number of unsuccessful and successful switches. Time needed to produce switch.
Prosthesis task: Duration of correctly re-placing a set of 6 clothespins.
Primary outcome measure for pre- and posttest;
Duration of correctly re-placing a set of 6 clothespins.
|- Secondary outcome||Secondary outcome measures;|
Proportional: Duration of the plateau phase of the aperture of the gripper in the game. Accuracy of catching. Number of broken/missed/bounced objects.
Displayed EMG signal:
Discrete: time needed to produce switch.
Proportional: Plateau time of hand opening
Discrete: Number of unsuccessful and successful switches.
All the above described measures will be ranked over participants per test. These ranks will be analyzed.
|- Timepoints||All subjects will be measured on 5 consecutive days (Monday-Friday). The pretest will be done at day one, the posttest on day 5. The training days will be on day 1, 2, 3, 4 and 5. |
The primary results are based on times and distances. These measures are all based on data collected from the avatar that is displayed on the screen, the EMG data collected during the second task and the data collected from the prosthesis hand.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Msc. A. Heerschop|
|- CONTACT for SCIENTIFIC QUERIES|| R.M. Bongers|
|- Sponsor/Initiator ||University Campus Fryslan, Revalidatiefonds Nederland|
(Source(s) of Monetary or Material Support)
|University Campus Fryslan, Revalidatiefonds Nederland|
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||21-mrt-2017 - 10-jul-2017|