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Scenarios and Clinical Trials

Scenarios and Clinical Trials

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Scenarios and Clinical Trials

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  1. Part-financed by the European Regional Development Fund Scenarios and Clinical Trials Annemarie Kokosy, Gareth Howells, Mohamed Sakel & Matthew Pepper ISEN/University of Kent/EKHUFT January 27th, 2012 Ecole Centrale of Lille

  2. Plan of presentation • First Scenario • Description • Prototype • Clinical evaluation II. Second Scenario • Description • Prototype • Clinical evaluation III. Third scenario

  3. First Scenario – Collision Avoidance • Description • The user drives the powered wheelchair via a joystick • The intelligent device must • Detect obstacles • Slow down the PW proportionally to the distance between the obstacle and the wheelchair • Stop the PW if the distance between the PW and the obstacles is less than the security distance, overriding any action by the user • Provide the user with visual feedback on the distance (measured by the sensors) between the wheelchair and the obstacles in its way • Have a switch to allow the user to enable or disable the device 3

  4. First ScenarioHardware Implementation at ISEN • ISEN Prototype • 2 electronic boards: 1 for the joystick and 1 (Arduino) for the data processing and navigation strategy • 9 US sensors • 2 IR sensors • visual feedback DupontMedical with DynamicControls Invacare Storm 3 with DynamicControls

  5. First Scenario Hardware Implementation at UoK • ISEN Prototype • The technical report to replicate the intelligent module (deliverable A3D1) is available and was sent to University of Kent at the end of November 2011 DupontMedical with DynamicControls Invacare Storm 3 with DynamicControls

  6. First scenarioHardware Implementation at UoK Prototype at University of Kent INVACARE Harrier Plus wheelchair Dynamics Control System • Processing, Beagle board or equivalent. • Sensor boards, Arduino or equivalent. • Sonar 5m (LV-MaxSonar-EZ4 MB1040). • I/R 5m (SHARP - GP2Y0A710K0F). • I/R 1.2m (SHARP-P2Y0A02YK0F). • Optical camera and Fisheye lens. • Magnetic compass (CMPS10). • Floor colour sensor (Inex). • Dynamic object sensor (GE/ ZTP-135S). • Drive shaft angular rate (existing motor). • Angular body rate (MLX90609-E2). • Acceleration/velocity (ADXL320). • Position (optical mouse sensor).

  7. First scenario • Clinical Trial: Hospital of Garches Second part First part 7

  8. First scenario: Clinical Trial - HG • Pilot study of 27 people divided into 3 groups • Group1: 9 healthy volunteers who have never driven an electric wheelchair • Group2: 9 experienced electric wheelchair users • Group3: 9 users who didn’t pass the electric wheelchair driver’s licence • Goal: reduce the number and severity of collisions • Methodology: create a circuit that simulates a real life indoor environment (walls, doors, obstacles) 8

  9. First scenario: Clinical Trial - HG • Evaluation Criteria: thenumber of collisions during the test, and the time the user needed to finish it. • Total duration of the test: 3 hours • Duration of the study: 5 months • Ethics Approvals: The clinical protocol has been approved by AFSSAPS (French agency for health and sanitary security) and the CPP (Commission for the protection of people) at the end of December 2011 • The clinical protocol and the observation booklet were sent to EKHUFT in November 2011 9

  10. First Scenario: Clinical Trial - HG • 3 users (from groups 1 & 3), have already taken the test • Some technical problems were identified • To go through doors (90cm) • To navigate along the corridor with obstacles (distance wall – obstacle = 1m) • For reverse navigation Solution (in progress) • To better locate the sensors to reduce dead zones • To change the navigation strategy 10

  11. First Scenario: Clinical Trial - EKHUFT • Pilot Study to Confirm Findings from HG • 9 healthy volunteers • 9 Patients selected by Dr Sakel • Provision of ISEN interface by UoK - ? • Testing of ISEN Interface at UoK - ? • Ethics Approval: The clinical protocol has to be developed and application made to the National Research Ethics System via the Integrated Research Application System (IRAS) – October 2012 11

  12. First Scenario: Clinical Evaluation - EKHUFT • Repeated for each patient over Hospital stay • Evaluation Criteria: • Number of collisions during the completion of the clinical test path • The time to complete the path. • Patient Evaluation/Experience – Questionnaire to be developed • Subject Participation duration: 1hour? • Duration of the study: 5 months • Possibly at same time as Scenario 2? 12 12

  13. Second scenario (HG) • Description • The user drives the powered wheelchair using a joystick • The intelligent device must • Detect obstacles • Detect Steps/Stairs • Avoid obstacles, overriding any user action if necessary • Go autonomously through doorways • Provide feedback to the user (must be visual or audible) • Have a switch to allow the user to enable or disable the device • Have a switch to allow the user to enable the “pass through doorways” mode 13

  14. Second scenario • Prototype: new challenges • Obstacle avoidance  idea: use the potential field method (the joystick direction=attractor; obstacles = repulsor) • Second prototype vs first one • Use of US and IR sensors for obstacle detection • Use the Arduino board for data processing • New data: camera and/or laser for position and velocity estimations • Use of a PC or mother board (If PC not allowed for the ethics approval) for data processing and navigation algorithm • What kind of device for the user's feedback ? • A switch to change between the autonomous or semi-autonomous navigation 14

  15. Second scenario • Prototype: who uses what kind of sensors and for which goal? 15

  16. Second scenario • Main results 16

  17. Second Scenario: Clinical trial • Hospital of Garches • Define the clinical protocol with the SYSIASS team • Ask for the Ethics approval • Initial Evaluation of the prototype in a clinical environment – January 2013? 17

  18. Third Scenario • Based on the first results of the survey on user needs • Survey • Start date: November 2011 • End date: April 2012 • Questionnaire available in French and English on our web site (www.sysiass.eu) • Realized by ISEN/GHICL in collaboration with 2 rehabilitation centers (BercksurMer and Villeneuve d’Ascq) and the Social Institute of Lille 18

  19. Third scenario • First results of survey: Conclusion Scenario 1: collision avoidance  The intelligent device doesn’t correct the trajectory Scenario2: assisted navigation in semi-autonomous way • The user drives the powered wheelchair • The intelligent device avoids obstacles with the user action on the loop • The going through doorways is autonomous (the user chooses this option) The survey results allow us to define a third scenario: autonomous navigation EKHUFT also proposes a scenario (see the next presentation) 19

  20. Project plan – Time line End 31Dec/2013 Feb/2012 Aug/2012 Feb/2013 Aug/2013 4/12 6/12 10/12 12/12 4/13 6/13 10/13 12/13 1st scenario Technical work Clinical trials 2nd scenario Technical work Clinical trials Ethics Approval 3rd scenario Technical work Clinical trials Ethics Approval 20