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van CCT (UK)

van CCT (UK)

Vibrational stimulation on the skin to provide feedback about the grasping force or hand opening of forearm prostheses during daily life grasping tasks.

- candidate number14547
- NTR NumberNTR3924
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-mrt-2013
- Secondary IDsNL44020.044.13 CCMO
- Public TitleVibrational stimulation on the skin to provide feedback about the grasping force or hand opening of forearm prostheses during daily life grasping tasks.
- Scientific TitleVibrotactile feedback in forearm prostheses in daily life grasping tasks.
- ACRONYMMyopro feedback 2
- hypothesisGrasping performance of daily life grasping tasks will be improved when vibrotactile feedback about the hand opening and grasping force is provided compared to situations without vibrotactile and visual feedback.
- Healt Condition(s) or Problem(s) studiedForearm amputation, Congenital defect of the forearm, Myoelectric forearm prosthesis
- Inclusion criteria1. Age between 18 and 65 years;
2. Able to control the experimental setup;
3. Forearm circumference between 24 and 28 cm (healthy subjects);
4. Forearm stump of at least 8 cm (patients);
5. Myoelectric prosthesis user (patients).
- Exclusion criteria1. Self-reported diminished sense of touch (healthy subjects);
2. Experience with vibrotactile stimulation (healthy subjects);
3. Experience with EMG control of a prosthesis or other device (healthy subjects);
4. Extreme skin problems at the forearm;
5. Mental problems;
6. Hypersensitivity of the skin of the stump (patients).
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-mei-2013
- planned closingdate15-aug-2013
- Target number of participants20
- InterventionsAll subjects will be asked to perform grasping tasks (1-within a standardized protcol using the SHAP test, 2-grasping of delicate daily life objects, 3-grasping of abstract objects varying in weight, size and stiffness). All tasks are being performed with a commercial myoelectric forearm prosthesis, controlled by muscle activity (EMG) from the forearm (stump). During these tasks, vibrotactile feedback about the grasping force and the hand opening of the prosthesis is provided through a single vibrating element (C2 tactor) and an array of 8 coin motors respectively.
- Primary outcomeThe performance in the grasping tasks, expressed in:
1. The time needed to perform the tasks;
2. The success in grasping (percentage objects grasped without slippage or breakage);
3. The Index of Functionality (IoF), the main outcome measure of the SHAP test.
- Secondary outcome1. The number of trials needed to successfully hold the object;
2. The force safety marging (difference between the required and the applied grasping force);
3. The percentage correcly identified objects (indication of object stiffness, size and weight).
- TimepointsAll measurements will be performed on 1 day. For the patient measurements, a user specific prosthesis socket will be made at least one week before the experiments.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator University of Twente
- Funding
(Source(s) of Monetary or Material Support)
Ministry of Economic Affairs, PIDON (Pieken in de Delta Oost Nederland)
- PublicationsN/A
- Brief summarySensory feedback about grasping force and hand opening of a myoelectric forearm prosthesis is very important in optimal object handling, but lacking in current commercial prostheses. We have developed and evaluated methods to provide hand opening and grasping force feedback via vibrotactile stimulation to the skin. However, virtual environments were used in the previous studies. Therefore, in this study the concepts for vibrotactile hand opening and grasping force feedback will be evaluated in daily life grasping tasks. Three kinds of grasping taks will be performed: 1) daily life grasping tasks within the standardized SHAP protocol, 2) grasping of delicate daily life objects and 3) grasping of abstract objects with varying weights, sizes and stiffness.
- Main changes (audit trail)
- RECORD20-mrt-2013 - 8-apr-2013

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