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van CCT (UK)

van CCT (UK)

Developing a new test for ability to control an arm prosthesis.

- candidate number23486
- NTR NumberNTR5593
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-dec-2015
- Secondary IDsECB 2014.02.28_1  
- Public TitleDeveloping a new test for ability to control an arm prosthesis.
- Scientific TitleComparing tests for myocontrol before, during and after training to determine the underlying mechanism.
- hypothesisIn the process of developing a serious game for testing patientsí level of myocontrol a part of the test needs to be validated. In a previous trial we found differences between several tests that need further inspection. The current study focusses on determining whether subject are equally good at a game and a similar prosthesis task after a period of training.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteriaThe 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 criteriaSubjects 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 receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 14-dec-2015
- planned closingdate18-mrt-2016
- Target number of participants15
- InterventionsDuring this study all subject will undergo two tests. One of these tests will be executed with the use of a myoelectric prosthesis simulator. The other test will be executed in a virtual environment, using a serious game. Both the myoelectric prosthesis simulator and the serious games are controlled using surface EMG measured on the flexor and extensor of the wrist. All participants will come back on five consecutive days to train both test for 12 minutes each. The two tests will be presented to the participants in a random order. During the serious game, only level one will be played.
- Primary outcomePrimary outcome measure per test; 1. Serious game: Adaptive catching; the plateau phase of the aperture of the gripper in the game (grasping profile) and he difference between the aperture of the virtual gripper and the diameter of three differently sized virtual balls a. Prosthesis task: Compressible objects; Duration of maximum hand aperture (i.e., plateau phase, goniometer) and the number of millimeters the compressible objects are compressed. The above described measures will be ranked per test. These ranks will be analyzed.
- Secondary outcomeSecondary outcome measures; 1. Adaptive catching a. Number of bounced objects b. Accuracy. This is defined as the total number of items caught divided by the number of object that reached the bottom of the screen (dropped and missed objects). 2. Compressible objects a. Aperture of the hand b. Opening velocity c. Closing velocity
- TimepointsAll subjects will be measured for 24 (2x12) minutes on five consecutive days. The primary results are based on magnitudes. In the prosthesis task these distances will be measured using a goniometer and a calliper. In the serious game these measures are based on data collected from the gripper that is displayed on the screen.
- Trial web site
- statusopen: patient inclusion
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryRecruting countries: the Netherlands
- Main changes (audit trail)
- RECORD13-dec-2015 - 14-feb-2016

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