1. Clinical Evaluation of Autonomous Wheelchair Scenario 2 EKHUFT & EDA UoK Annemarie Kokosy, Gareth Howells Mohamed Sakel & Matthew Pepper ISEN/UoK/EKHUFT 27 01 2012 ISEN Lille 1 Part-financed by the European Regional Development Fund

2. Part-financed by the European Regional Development Fund Scenario 2 I.Goal II.Methodology III.Setting and Scenario IV.Outcome Measures V.Participants VI.Approval VII.Timing VIII.System Requirements 2

3. Part-financed by the European Regional Development Fund Scenario 2 - Goal – Assisted Navigation Clinical Evaluation - Collision avoidance and assisted navigation. 2 aspects: Implemented at UoK and EKHUFT – controlled environment – Lab or Gym – controlled and uncontrolled environment – corridor navigation 3

4. Part-financed by the European Regional Development Fund Methodology Single Case Design methodology ABAB. – User is the control for the outcome measurement done before after intervention. – System off [A] & on [B] by all participants + 1 obstacle Insert the schematic----------------- 4

5. Part-financed by the European Regional Development Fund Scenario 2 Setting Controlled Environment – EDA UoK: open space with Cones – as far as practical replicating ISEN test at Hospital Garches. Uncontrolled Environment – EDA UoK: Navigate round upper corridor of EDA. – Describe pathway; two stair wells, multiple doors, corridor with uncontrolled number of persons. – Clockwise and anticlockwise. Evaluation of system performance, reliability and safety. Outcome a system suitable for EKHUFT use. 5

6. Part-financed by the European Regional Development Fund Scenario 2 Setting Uncontrolled Environment – EKHUFT NeuroRehab Unit: Real life and realistic context: patients routinely use + safe + supervised + not undue attention by audience (to minimise Hawthorn effect) – Clinic to External Garden – approx 40 meters – A description of path [Plan to be produced]. Pathway: Start at table in clinic with back to door one meter away. Reverse away from table and turn in confined space in clinic to exit through door. Turn left into corridor. 30 meters to end of corridor passing corridor on the left and right. Exit through doors and turn right into a more open area with garden [Drawing to be provided]. – Describe the obstacle: Doctor (co-investigator) standing exactly at midpoint of the route. 6

7. Part-financed by the European Regional Development Fund Outcome Measures Time taken Number of collisions Number & level of interventions by the control system User experience: patient, carer, clinician, normal volunteer: – global perception + free text – any standard measure (Clinical Rehab paper). – Questionnaire required. 7

8. Part-financed by the European Regional Development Fund Participants Normals at EDA and EKHUFT: 6 Patients at EKHUFT – Wheelchair naïve -3 – Experienced user -3 Inclusion Criteria – Over 18 – No cognitive or visual disorders – Able to give informed consent – Agree to participation 8

9. Part-financed by the European Regional Development Fund Approval for Clinical Evaluation Medical Devices Directive? – Evaluation of a Medical Device requires approval before clinical evaluation. – Embedded Software may be class IIA – Require Confirmation of action to be taken. Ethics Permission – Approval process to be implemented by EKHUFT Information from Garches? – EKHUFT R&D Governance Ethics approval is one aspect. 9

10. Part-financed by the European Regional Development Fund Project Plan - Gantt Chart/Time Line EDA – Implementation of ISEN system for evaluation at EDA 2 months [end of March] - Funding for parts re FLC issues + delay? – Evaluation of EDA aspect of scenario 2: + 4 months? EKHUFT – MDD Approval for EKHUFT Clinical Evaluation– is this required? – Ethics Approval [6 months?] – EKHUFT Approval – with Ethics Approval – Initial Evaluation in Clinical Environment – December 2012? 10

11. Part-financed by the European Regional Development Fund System Requirements –Technical Specifications Dynamic Serial Interface – User manual/data from Dynamic required – Implementation via secondary remotes Secondary remotes required e.g. DX-RJM Still required to “break into” joystick output. – Powered Chair for Essex. Recording of Data – time – store input from the joystick – sensor data – output data back to the chair. It may not be necessary to monitor both output data and sensor data? – monitoring intervention by system 11

12. Part-financed by the European Regional Development Fund System Requirements – Technical Specifications Data Analysis [Future Work] – how the user is driving the chair – whether their driving is improving – response to rehabilitation. – whether they are getting worse if they have a progressive condition – whether they are getting tired – measurement of tremor – Etc 12

13. Part-financed by the European Regional Development Fund System Requirements – Technical Specifications Risk Management – Recognise Stairs – Closed Doors – Doors too narrow to pass through – Stationary objects – Moving objects - without becoming confused e.g. several people – Software – fault tolerant – Minimise physical size – No increase in length or width of powered chair? – No additional sharp points/ obtrusions – Visual impact Meet requirements of MDD for Clinical Evaluation – Hardware and Software – What is required? 13