1. Roessingh Research and Development Karin Groothuis-Oudshoorn, Phd Roessingh Research and Development Karin Groothuis-Oudshoorn, Phd

2. Mission statement Roessingh Research and Development wants to be an internationally acknowledged research institute that generates new knowledge and clinical applications with respect to rehabilitation where it will actively support the implementation of this knowledge in health care

3. Some Characteristics of RRD Focussed on rehabilitation Over 50 academic people (engineers & clinicians) Strong formalised connections to large rehabilitation centre and University European orientation Research focus on: 1.Diagnostics (sensing) 2.Restoration of function 3.Telemedicine

4. Diagnostics Restoration of human function Neuro- modulation (Neural) prostheses Motor TrainingMovement analysis Motor control Spasticity Rehabilitation-technology

5. catastrophizing Clinical researchPsycho-neurophysiological Brain activity EEG, ERP, TMS NeuromodulationEMG activationChronificationDecision support Acute Fear of movement Avoidance Pain rehabilitation

6. Effects on walking speed: Yes Changes in motor control: ? Carry over effects: ? Effect of an Implanted stimulator on motor control

7. Review committee (METC) The Medical Research Involving Human Subjects Act (WMO) covers scientific research in which people are subjected to interventions or have to follow established behavioural rules (1 december 1999). The WMO is revised (1 march 2006) to take account of the implementation of the EU Good Clinical Practice Directive (2001/20/EC)EU Good Clinical Practice Directive (2001/20/EC)

8. METC Roessingh At least 10 protocols per year (2005: 16; 2006: 11; 2007: 7, including feasibility statements for the clinic). Members: –Physician –Ethical expert –Lawyer –Assessor specifically from the human subject´s point of view –Research methodologist ( Biostatistician) –Physiotherapist / researcher (non obligatory member)

9. Problems occuring in Rehabilitation research Small patientgroups Blinding difficult For pain: treatment usually in groups Outcome measures with relative large variability between patients Unknown variability or expected effectsizes

10. Problems occuring in Rehabilitation research, RCT’s. Sample size (practical vs minimal needed) Missing data Disappointing results Outcomes on different levels of ICF (functioning, disability and health)

11. Suggestions? Other designs: cross-over design; multiple baseline design (extended single subject design). Other outcomes or intermediate endpoints? Focus more on feasibility trails (with what objective?). Search for prognostic factors in order to define subgroups of patients.