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Roessingh Research and Development
Karin Groothuis-Oudshoorn, Phd
Roessingh Research and Development
Karin Groothuis-Oudshoorn, Phd
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
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 function3. Telemedicine
Effects on walking speed: Yes
Changes in motor control: ?
Carry over effects: ?
Effect of an Implanted stimulator on motor control
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)
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)
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
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)
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.