|- candidate number||14481|
|- NTR Number||NTR3888|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||8-mrt-2013|
|- Secondary IDs||NL43335.042.13 / 2013.072; CCMO / METC|
|- Public Title||Optimizing intermanual transfer effects.|
|- Scientific Title||Optimizing the intermanual transfer effects after training with a prosthetic simulator.|
|- hypothesis||Type and intensity of the tasks trained influence the training effects while using a myo-electric prosthesis.|
|- Healt Condition(s) or Problem(s) studied||Upper extremity, Prothesis, Simulators, Motor skill learning, Training program|
|- Inclusion criteria||Normal or corrected to normal sight and right-handed. |
|- Exclusion criteria||Neurological problems concerning upper extremity or torso, motor problems concerning upper extremity or torso, earlier experience with a prosthetic simulator and limited sight despite correction.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-apr-2013|
|- planned closingdate||7-okt-2013|
|- Target number of participants||100|
|- Interventions||Pretest-posttest intervention. Participants in the experimental group will train different tasks or on different intensities for 5 sessions with a prosthetic device or simulator. Participants in the control group do receive a sham training with the sound hand. Performance on reaching, grasping and force control, will be tested during three tests, a pretest, a posttest and a retention test. |
|- Primary outcome||1. Grip force control: Mean deviation of the asked force in N;|
2. Reaching: Mean deviation of the straight path towards the aim in mm;
3. Grasp: Shape of the grasp profile; plateau duration in s;
4. Movement time: Time taken to execute the movement in s.
|- Secondary outcome||Initiation time: Time between the starting signal and the actual start in s. |
|- Timepoints||The first experiment will take place in April, May, June, the second experiment in august and september. The patients will be measured during the whole period. |
|- Trial web site||N/A|
|- status||recruitement status not public|
|- CONTACT FOR PUBLIC QUERIES|| S. Romkema|
|- CONTACT for SCIENTIFIC QUERIES|| S. Romkema|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|Revalidatiefonds, Fonds Nuts-Ohra, Stichting Beatrixoord, Stichting OIM|
|- Brief summary||Rationale: |
To improve the rate of use of prosthetic devices in adults with an upper limb amputation intermanual transfer might be helpful. Intermanual transfer is the ability to transfer motor skills from one, trained side to the other side (Hicks, 1983). This can be used in upper limb amputees by training the unaffected arm while waiting for the prosthesis to be fitted. Especially because it is assumed that training starting early after the amputation will lead to better acceptance and improved prosthetic handling (Malone et al., 1984). Due to intermanual transfer, the prosthetic skills of the affected arm will then improve. Intermanual transfer effects were demonstrated to be present in myo-electric (Romkema, Bongers, & van der Sluis, 2013) and body-powered prosthesis use (Weeks, Wallace, & Anderson, 2003). However, it is unclear how the training program should be like to obtain the largest effects. First, the question rises which tasks the training program should contain to lead to the largest effects of intermanual transfer. Second, it is unknown how the training should be spaced over time for the best results.
To compare 1) different training tasks and 2) different training intensities to be able to measure which training has the largest effects. And, 3) whether the effects of this training can also be made visible in patients.
Experiments 1 and 2 are non-blinded randomized trials, experiment 3 is a case series.
(1) 60 non-amputated adults; (2) 36 non-amputated adults; (3) 4 amputees who will start to use a myo-electric prosthesis for the first time.
In experiment 1 and 2 in total eight groups of 12 participants train to use a prosthetic simulator for 20 min during 5 days. In experiment 3, four patients with an amputation train (5 times 20 min) with the prosthetic simulator on the unaffected arm. The prosthetic simulator mimics the functioning of a real prosthesis but can be worn by able-bodied participants and at the sound side of an amputee patient. The prosthesis simulator places a prosthetic hand in front of the sound hand.
Main study parameters/endpoints:
1. Grip force control: mean deviation of the asked force in N;
2. Reaching: mean deviation of the straight path towards the aim in mm;
3. Grasp: shape of the grasp profile; plateau duration in s;
4. Movement time: time taken to execute the movement in s;
5. Initiation time: time between the starting signal and the actual start in s.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
All participants will use the prosthetic simulator. This simulator mimics a real prosthetic device and can be worn over a sound arm. Because of the use of this simulator we are able to test more participants than only the few recently amputated patients. Importantly, all the measurements are non-invasive and the use of a prosthetic simulator is not different from wearing a regular prosthesis. Therefore, the risks associated with participation can be considered negligible and the burden can be considered minimal.
|- Main changes (audit trail)||The first study is executed. In this study we did not found significant intermanual transfer effects. Because the design might have been the reason for this finding, we changed the design of the second study.
First of all we decided to add a control group for both training intensities. With this, we first can determine whether intermanual transfer effects are present before comparing different intensities. Because of this the amount of participants is increased until 64.
Furthermore, to gain larger training effects we increased the length of the training from 20 to 30 minutes. This will also be the case for the patients.
The closing date is changed to 15 December 2013.
|- RECORD||8-mrt-2013 - 29-okt-2013|