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Simulators in experienced upper limb prosthesis users.


- candidate number21025
- NTR NumberNTR4911
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-nov-2014
- Secondary IDsNL35268.042.11 (MEC- UMCG title) 
- Public TitleSimulators in experienced upper limb prosthesis users.
- Scientific TitleThe clinical application of myo-electrical prosthesis-simulators in learning to use an arm-prosthesis: experienced prosthesis users.
- ACRONYM
- hypothesisExperienced myo-electrical prosthesis users are more skilled in handling a myo-electrical prosthesis-simulator on their sound arm, compared to persons without myo-electrical experience. This is due to intermanual transfer from their well-trained affected arm to their sound arm.
- Healt Condition(s) or Problem(s) studiedUpper extremity, Prothesis
- Inclusion criteriaExperienced (> two months) myo-electric prosthetic users (using prosthesis at least three days per week, one hour per day for the last month).
Control group: no experience with myo-electric prosthesis.
- Exclusion criteria1) No normal or corrected to normal vision; 2) adverse neurologic condition; 3) earlier experience with the prosthesis simulator.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, randomized
- Studytype[default]
- planned startdate 26-nov-2014
- planned closingdate5-apr-2015
- Target number of participants40
- InterventionsIntervention group and control group are tested on their ability to control a prosthesis simulator with the sound hand. Here fore three different tests are executed.
- Primary outcomeMovement time, force control and Box& Blocks score.
- Secondary outcomeMaximum hand opening; Hand dominance, age and sex influences on primary outcomes.
- TimepointsMovement time is recorded while the test person performs a functional grasping task. There are 3 different tasks, that are randomly selected and each task is performed 3 times. Total amount of time: 8 minutes.

Force control is measured while the test person produces a line on a computer screen, by manipulating a handle that is connected to the computer. The produced line has to follow as closely as possible another line on the screen that is generated by the computer. Total amount of time: 6 minutes.

Box&blocks score is measured while the test person is performing the Box & blocks-test using the standard protocol. This task is performed 3 times. Total amount of time: 4 minutes.
- Trial web site
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIES E. Boer, de
- CONTACT for SCIENTIFIC QUERIES S. Romkema
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
Stichting Beatrixoord, Marco Polo Fund, Groninger Universiteitsfonds (GUF), INAIL Centro Protesi (Italy)
- Publications
- Brief summaryTraining with one arm can also increase the skills of the other arm. This concept is called Intermanual Transfer. This can be beneficial to prosthesis- patients right after amputation, for they are able to train their sound arm with a prosthesis simulator and thus they will be trained in advance for the prosthesis-use with their affected arm. In this study, we are investigating whether intermanual transfer exists between the well trained affected arm of experienced myo-electric prosthesis users towards the untrained sound arm. To test this, both the experimental group (experienced myo electric users) and a control group of able- bodied volunteers perform different tasks with a prosthesis-simulator on their sound arm. It is expected that the experienced myo-electric users will perform these tasks better than the control group.
- Main changes (audit trail)
- RECORD24-nov-2014 - 10-jan-2015


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