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Integration of feedback and control in a trans-femoral prosthesis.


- candidate number8173
- NTR NumberNTR2382
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jun-2010
- Secondary IDs P10-19 / NL 32677.044.10 METC
- Public TitleIntegration of feedback and control in a trans-femoral prosthesis.
- Scientific TitleIntegration of feedback and control in a trans-femoral prosthesis.
- ACRONYMPhysiological control of trans-femoral prosthesis
- hypothesisControl and feedack integrated into a trans-femoral prosthesis can increase the usability of the prothesis for the trans-femoral amputee.
- Healt Condition(s) or Problem(s) studiedTrans-femoral amputee, Feedback, Motor control
- Inclusion criteriaHealthy:
1. Age between 18 and 30 years old;
2. Able to perform ADL without any problems.

Trans-femoral amputees (TFA):
1.Age between 18 and 70 years old;
2. Recovered from surgery;
3. Actively wearing and trained in wearing a trans-femoral prosthesis;
4. Able to perform ADL with use of trans-femoral prosthesis.
- Exclusion criteriaHealthy subjects:
1. Not able to perform ADL;
2. Lower extremity deficiencies (e.g. knee problems, disabilities in walking);
3. Neurodegenerative diseases;
4. Skin conditions (prone to electrodes, tape etc.).

TFA:
1. Not able to wear a trans-femoral prosthesis;
2. Further disabilities in walking;
3. Not able to perform ADL;
4. Neurodegenerative diseases;
5. Skin conditions (prone to electrodes, tape etc.).
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-jul-2010
- planned closingdate1-jan-2013
- Target number of participants65
- Interventions1. EMG measurements;
2. Electrotactile stimulation;
3. Vibrotactile stimulation.

For the EMG measurements the subjects will receive EMG electrodes on several muscles and they will be asked to perform activities of daily life (ADL). For the feedback experiments the subjects will receive vibrotactile or electrotactile stimulation during ADL. For healthy subjects either no further intervention takes place or they will walk with a TFP-simulator designed for non-amputees (TFP-sim). The amputees will use their own socket to which either their own prosthesis or another (controllable) prosthesis will be attached. For the combined experiments both EMG electrodes and vibrotactile and / or electrotactile stimulation will be applied during ADL.
- Primary outcome1. EMG control algorithm for TFP;
2. Feedback strategy for TFP;
3. Combined control and feedback loop for TFP.
- Secondary outcome1. Electrotactile array;
2. Vibrotactile array;
3. Vibrotacitle parameters (frequency, etc.);
4. EMG muscle patterns.
- TimepointsN/A
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES E.C. Wentink
- CONTACT for SCIENTIFIC QUERIES E.C. Wentink
- Sponsor/Initiator University of Twente
- Funding
(Source(s) of Monetary or Material Support)
STW/NWO
- PublicationsN/A
- Brief summaryRationale:
In the day to day life of a trans-femoral amputee (TFA) a stumble or a fall is not uncommon, mainly due to the lack of feedback and control of the prosthesis. Proprioception and motor control are essential for all motor tasks, but that is exactly what a TFA is missing in the prosthetic leg. The ultimate goal of this project is to allow TFA to control their prosthesis and to give them feedback, where necessary, during activities.

Objective:
There are multiple objectives to this study. First, we want to find a way of controlling the prosthesis using electromyography (EMG) of the muscles left in the stump. Secondly, we want to find a way to give feedback to the human during certain “states” of the prosthesis. Finally we want to combine the control and feedback to form a closed-loop system.

Study design:
For this study multiple experiments will be performed on healthy subjects (students), for initial testing, and TFAs, for testing and finalizing the setup. First, to determine EMG patterns, for the design of an algorithm to control the prosthesis. Secondly, to find the optimal way of giving feedback to the TFA (vibrotactile and electrotactile stimulation). Finally, evaluation experiments in TFAs to test the closed loop system.

Study population:
Healthy volunteers, between 18 and 30 years old, and trans-femoral amputees who have and use their trans-femoral prosthesis (TFP) on a regular basis.

Intervention:
For the EMG measurements the subjects will receive EMG electrodes on several muscles and they will be asked to perform activities of daily life (ADL). For the feedback experiments the subjects will receive vibrotactile or electrotactile stimulation during ADL. For healthy subjects either no further intervention takes place or they will walk with a TFP-simulator designed for non-amputees (TFP-sim). The amputees will use their own socket to which either their own prosthesis or another (controllable) prosthesis will be attached. For the combined experiments both EMG electrodes and vibrotactile and / or electrotactile stimulation will be applied during ADL.

Main study parameters:
Firstly, EMG measurements are used to design an algorithm which can detect the intention of the subject and timings of certain events during ADL (e,g, push-off during walking) to control a prosthesis. The algorithm is then tested and improved using healthy subjects and TFA. Secondly, feedback experiments will provide us with a method of giving feedback to the subject on the state of the prosthesis without conscious attention of the subject. Finally the optimized EMG algorithm will be combined with the best functioning feedback modality to form a controlled TFP.
- Main changes (audit trail)
- RECORD22-jun-2010 - 29-jul-2010


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