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Designing Intervention Protocols to Improve Muscle Performance and Movement Skill: Exposing the Hidden Aspects of Clinic

Designing Intervention Protocols to Improve Muscle Performance and Movement Skill: Exposing the Hidden Aspects of Clinical Research Carolee Winstein, PhD, PT, FAPTA, Symposium Moderator. Combined Sections Meeting: APTA, New Orleans, LA, Feb 23-27, 2005. Symposium Agenda: .

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Designing Intervention Protocols to Improve Muscle Performance and Movement Skill: Exposing the Hidden Aspects of Clinic

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  1. Designing Intervention Protocols to Improve Muscle Performance and Movement Skill: Exposing the Hidden Aspects of Clinical Research Carolee Winstein, PhD, PT, FAPTA, Symposium Moderator Combined Sections Meeting: APTA, New Orleans, LA, Feb 23-27, 2005

  2. Symposium Agenda: • 1:00-1:20 Introduction: Evidence-based practice and protocol development for PTClinResNet…..CaroleeWinstein, PT, PhD, FAPTA • 1:25-1:55 Standardized exercise regimens for the STEPS (strength-training effectiveness post stroke) project: Finding the starting point and progressing forward….KatherineSullivan, PT, PhD • 2:00-2:30 Development of a person specific post-surgical rehabilitation program: A microtopography of interventions in a randomized clinical trial....Kornelia Kulig, PT, PhD • 2:35-3:05 Standardized exercise regimens for the PEDALS (Pediatric endurance development and leg strengthening) project: A protocol to promote fitness and strengthening for children with disability….Eileen Fowler, PT, PhD • 3:10-3:40 Development of an individualized and standardized intervention protocol for the STOMPS (Strength training and optimal movements post spinal-cord injury) project: How to deal with shoulder pain in chronic spinal cord injury….Craig Newsam, DPT • 3:45-4:00 Panel Discussion with Q&A from audience

  3. PTClinResNet Established in 2003 with a grant from the Foundation for Physical Therapy and institutional support from the participating satellite sites

  4. PTClinResNet has three aims: • To conduct four Randomized Clinical Trials (RCT) to evaluate efficacy of complex interventions. • STEPS, MUSSEL, PEDALS, STOMPS • Build the infrastructure to support clinical trials research • Education and training (knowledge transfer) These three are not mutually exclusive but, instead, mutually inter-dependent

  5. Four RCTs (Aim 1): • STEPS: Strength-training effectiveness post stroke • David Brown, Ph.D., P.T., Lead Investigator • MUSSEL: Muscle specific strengthening effectiveness post lumbar microdiscectomy • Kornelia Kulig, Ph.D., P.T.,Lead Investigator • PEDALS: Pediatric endurance development and limb strengthening • Eileen Fowler, Ph.D., P.T., Lead Investigator • STOMPS: Strengthening and optimal movements for painful shouldersin chronic spinal cord injury • Sara Mulroy, Ph.D., P.T.,Co-Lead Investigator

  6. University of Southern California Biokinesiology and Physical Therapy Department Coordinating Center Scientific Advisory Panel Data Monitoring and Safety Committee Network Sites Randomized Clinical Trials Projects University of Southern California STEPS (CVA) Phase II Rancho Los Amigos National Rehabilitation Center Northwestern University PEDALS (CP) Phase I Central Data Management and Analysis Impairment (resources), Function (skills), Disability (roles) University of California, Los Angeles MUSSEL (Spine) Phase II Orthopaedic Hospital, Los Angeles Southwest Missouri State University STOMPS (SCI) Phase I 23 Outpatient Clinics, Greater Los Angeles Area

  7. University of Southern California Biokinesiology and Physical Therapy Department Coordinating Center Scientific Advisory Panel Data Monitoring and Safety Committee Network Sites Randomized Clinical Trials Projects University of Southern California STEPS (CVA) Phase II Rancho Los Amigos National Rehabilitation Center Northwestern University PEDALS (CP) Phase I Central Data Management and Analysis Impairment (resources), Function (skills), Disability (roles) University of California, Los Angeles MUSSEL (Spine) Phase II Orthopaedic Hospital, Los Angeles Southwest Missouri State University STOMPS (SCI) Phase I 23 Outpatient Clinics, Greater Los Angeles Area

  8. University of Southern California Biokinesiology and Physical Therapy Department Coordinating Center Scientific Advisory Panel Data Monitoring and Safety Committee Network Sites Randomized Clinical Trials Projects University of Southern California STEPS (CVA) Phase II Rancho Los Amigos National Rehabilitation Center Northwestern University PEDALS (CP) Phase I Central Data Management and Analysis Impairment (resources), Function (skills), Disability (roles) University of California, Los Angeles MUSSEL (Spine) Phase II Orthopaedic Hospital, Los Angeles Southwest Missouri State University STOMPS (SCI) Phase I 23 Outpatient Clinics, Greater Los Angeles Area

  9. University of Southern California Biokinesiology and Physical Therapy Department Coordinating Center Scientific Advisory Panel Data Monitoring and Safety Committee Network Sites Randomized Clinical Trials Projects University of Southern California STEPS (CVA) Phase II Rancho Los Amigos National Rehabilitation Center Northwestern University PEDALS (CP) Phase I Central Data Management and Analysis Impairment (resources), Function (skills), Disability (roles) University of California, Los Angeles MUSSEL (Spine) Phase II Orthopaedic Hospital, Los Angeles Southwest Missouri State University STOMPS (SCI) Phase I 23 Outpatient Clinics, Greater Los Angeles Area

  10. University of Southern California Biokinesiology and Physical Therapy Department Coordinating Center Scientific Advisory Panel Data Monitoring and Safety Committee Network Sites Randomized Clinical Trials Projects University of Southern California STEPS (CVA) Phase II Rancho Los Amigos National Rehabilitation Center Northwestern University PEDALS (CP) Phase I Central Data Management and Analysis Impairment (resources), Function (skills), Disability (roles) University of California, Los Angeles MUSSEL (Spine) Phase II Orthopaedic Hospital, Los Angeles Southwest Missouri State University STOMPS (SCI) Phase I 23 Outpatient Clinics, Greater Los Angeles Area

  11. University of Southern California Biokinesiology and Physical Therapy Department Coordinating Center Scientific Advisory Panel Data Monitoring and Safety Committee Network Sites Randomized Clinical Trials Projects University of Southern California STEPS (CVA) Phase II Rancho Los Amigos National Rehabilitation Center Northwestern University PEDALS (CP) Phase I Central Data Management and Analysis Impairment (resources), Function (skills), Disability (roles) University of California, Los Angeles MUSSEL (Spine) Phase II Orthopaedic Hospital, Los Angeles Southwest Missouri State University STOMPS (SCI) Phase I 23 Outpatient Clinics, Greater Los Angeles Area

  12. Implicit Guiding Principles: • Disablement-Rehabilitation Framework • What is the relationship between impairment-level changes, function or skill and disability? • Design the intervention based on scientifically sound principles to enhance muscle performance (protocol development) • Maintain the scientific rigor while not compromising the clinical meaningfulness or applicability of the work • Balance between ‘efficacy’ and ‘effectiveness’

  13. Current status of evidence in rehabilitation • There are no more than a handful of Phase III clinical trials in physical therapy that are currently funded or in the proposal stage… • Bad news—very few systematic clinical trials research in rehabilitation • Good news—more case reports; more small scale modeling—hypothesis driven, and systematic outcomes assessment (phase I), and a few exploratory (phase II) trials

  14. Developmental process begins with theory • Scientific experimental development process • Theory—pre-clinical (we are sorely lacking here) • Modeling—phase I • Exploratory Trial—phase II • Definitive RCT—phase III • Long-term Implementation—phase IV Medical Research Council, April 2000 (Complex packages report-A framework for development and evaluation of RCTs for complex interventions to improve health, http://www.mrc.ac.uk/complex_packages.html)

  15. Medical Research Council, April 2000 (Complex packages report-A framework for development and evaluation of RCTs for complex interventions to improve health, http://www.mrc.ac.uk/complex_packages.html)

  16. Phase I (STOMPS, PEDALS) • “Identify the components of the intervention and the underlying mechanisms by which they will influence outcomes to provide evidence that you can predict how they relate to and interact with each other”.

  17. Phase II (STEPS, MUSSEL) • “Describe the constant and variable components of a replicable intervention AND a feasible protocol for comparing the intervention to an appropriate alternative”.

  18. Why so few full-scale RCTs? • Mounting clinical trials is not easy—why? They are costly $$$ • Typically, we have not followed a systematic progression in the development of our interventions to make a strong case for RCT (our knowledge and understanding of complex interventions is still immature). • More time and energy needs to be spent in the pre-clinical, phase I-II stages • We do not have a strong theoretical basis for our interventions • Evaluation of complex interventions affords some unique challenges. • Active ingredient(s) of the intervention that is effective is often difficult to specify (e.g., CIT, NDT)

  19. Why is the evaluation of complex interventions difficult? • Even seemingly straightforward interventions have inherent complexities to bedevil well-designed research: • e.g., What is the physical therapist’s contribution to the management of a knee injury? • Package of care may be straightforward and easily definable and therefore reproducible (e.g., series of exercises in this order, with this frequency, for this long with the following changes at specific stages…)

  20. However…in addition to the exercises, the physical therapist may have a… • Role in rebuilding the patient’s confidence (self-efficacy) • A training role teaching the family (spouse) how to help with care or rehabilitation • Potentially significant influence in the form of advice on the future health behavior of the patient. • Each of these elements may be an important contribution to the effectiveness of a physical therapist intervention.

  21. Complex interventions are built up from a number of components…. • which act both independently and inter-dependently. • components usually include behaviors, parameters of behaviors (e.g., frequency, timing, intensity) • methods of organizing and delivering those behaviors (e.g., type(s) of practitioner, setting, and location)

  22. An intervention does not exist in a vacuum…. • It is not easy to precisely define the “active ingredients” of a complex intervention. • e.g., research suggests that stroke units work…but what exactly is a stroke unit? What are the active ingredients that make it work? The physical set-up? The mix of care providers? The timing, frequency, dose of care? The skill of the providers? The technologies available? The organizational arrangements? * Substitute CIT or BWSTT for stroke unit

  23. Most challenging part…. • Of evaluating a complex intervention—and the most frequent weakness in such trials—is defining the actual intervention, that is, *standardizing the content and the delivery of the intervention by determining the critical components of the intervention, and how they relate to, and impact on each other. [*this is protocol development]

  24. Complex interventions such as those we employ in physical therapy… • ..tend to be marked by a paucity of high quality literature, and thus is is not unlikely that some level of original research will have to be undertaken in the early phase of evaluation of a complex intervention—refining theory through modeling activities is liable to be iterative. van Vliet et al., 2001

  25. Rehabilitation trials have unique characteristics • Patient is an active participant (patient-therapist interaction) • Compliance is not enough… • Masking is difficult • Placebos are difficult to construct and define • The proper level of analysis is difficult to establish • What unit should be studied? Impairments, functional limitations, disability? • Avoid comparisons of interventions at different levels • Outcomes are difficult to measure • Especially at disability level; consider self-efficacy • Effects take a long time to emerge • Long-term follow-up is essential; transfer of learning to real world

  26. Our Website… http://pt.usc.edu/clinresnet/

  27. Symposium Agenda: • 1:00-1:20 Introduction: Evidence-based practice and protocol development for PTClinResNet…..CaroleeWinstein, PT, PhD, FAPTA • 1:25-1:55 Standardized exercise regimens for the STEPS (strength-training effectiveness post stroke) project: Finding the starting point and progressing forward….KatherineSullivan, PT, PhD • 2:00-2:30 Development of a person specific post-surgical rehabilitation program: A microtopography of interventions in a randomized clinical trial....Kornelia Kulig, PT, PhD • 2:35-3:05 Standardized exercise regimens for the PEDALS (Pediatric endurance development and leg strengthening) project: A protocol to promote fitness and strengthening for children with disability….Eileen Fowler, PT, PhD • 3:10-3:40 Development of an individualized and standardized intervention protocol for the STOMPS (Strength training and optimal movements post spinal-cord injury) project: How to deal with shoulder pain in chronic spinal cord injury….Craig Newsam, DPT • 3:45-4:00 Panel Discussion with Q&A from audience

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