Simulators and upper limb prostheses.|
|- candidate number||10296|
|- NTR Number||NTR3053|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-aug-2011|
|- Secondary IDs||NL35268.042.11 CCMO|
|- Public Title||Simulators and upper limb prostheses.|
|- Scientific Title||Clinical application of simulators when learning to use upper limb prostheses.|
|- hypothesis||After training one arm with a prosthetic simulator it is expected that the other arm will improve. |
|- Healt Condition(s) or Problem(s) studied||Bimanual transfer, Upper limb prosthesis, Simulators|
|- Inclusion criteria||Healthy participants: Normal or corrected to normal sight, rigth handed. |
Experienced prosthetic users: Normal or corrected to normal sight, unilateral forearm amputation, experience with a myo-electric prosthese.
Novice prosthetic users: Unilateral forearm amputation.
|- Exclusion criteria||1. Limited sight despite correction;|
2. Motor problems concerning measured upper extremity;
3. Experience with the prosthetic simulator.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-aug-2011|
|- planned closingdate||28-feb-2012|
|- Target number of participants||116|
|- Interventions||The trainingsgroup gets a training with a prosthetic simulator for half an hour on 5 consecutive days, while the control group does not get any intervention. The training consist of the Southampton Hand Assessment Procedure.
In three tests, for both groups, the execution of tasks is analyzed.|
|- Primary outcome||During three tests, pretest (day 1), posttest (day 5) and retention test (day 11) the movement and initiation time of three functional activities are measured using E-prime. With two deformable objects the force control is measured (the amount of pressure applied). |
|- Secondary outcome||N/A|
|- Timepoints||First experiment 15-aug-2011;|
Second experiment 19-sept-2011;
Third and fourth 1-oct-2011.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| S. Romkema|
|- CONTACT for SCIENTIFIC QUERIES||Prof. dr. C.K. Sluis, van der|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||People with an upper extremity amputation often choose to have fitted a prosthesis to restore the functionality for as best as possible. But the rejection rate of prosthetic devices is high, mainly due to a low degree of functional use (Biddiss & Chau, 2007; Dudkiewicz, Gabrielov, Seiv-Ner, Zelig, & Heim, 2004; Kyberd, Davey, & Morrison, 1998; Plettenburg, 2002). Functional use can be enhanced by training (Carter, Torrance, & Merry, 1969; Lake, 1997; Weeks, Wallace, & Anderson, 2003). To achieve maximum success in prosthetic use it is important to start to train in the first weeks after the amputation (Atkins, 1992; Dakpa & Heger, 1997; Gaine, Smart, & Bransby-Zachary, 1997). However, in these initial stages of rehabilitation the wounds are not healed yet and the prosthesis is not finished. To be able to start training within these initial stages, we propose to use the unaffected limb. With an upper limb prosthetic simulator, as developed earlier in Groningen, training can start with the unaffected hand. It is hypothesised that training the unaffected hand results in a higher starting level and faster learning of the affected hand. This effect is called ‘transfer of learning’ (Hicks, Gualtieri, & Schoeder, 1983; Karni et al., 1998; Kumar & Mandal, 2005; Lee, Hinder, Gandevia, & Carroll, 2010; Mier & Petersen, 2006; Pereira, Raja, & Gangavalli, 2011).|
If we indeed establish that this transfer has effect on learning to use a prosthesis, then this might help the rehabilitation after an amputation of the upper limb to become faster and more efficient.
|- Main changes (audit trail)|
|- RECORD||31-aug-2011 - 2-dec-2011|
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