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Strength Training Effectiveness Post-Stroke (STEPS)

Strength Training Effectiveness Post-Stroke (STEPS). Lead Investigators: David A. Brown, PT, PhD Northwestern University, Chicago, IL Sara Mulroy, PT, PhD Rancho Los Amigos National Rehabilitation Center, Downey, CA Katherine J. Sullivan, PT, PhD

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Strength Training Effectiveness Post-Stroke (STEPS)

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  1. Strength Training Effectiveness Post-Stroke (STEPS) Lead Investigators: David A. Brown, PT, PhD Northwestern University, Chicago, IL Sara Mulroy, PT, PhD Rancho Los Amigos National Rehabilitation Center, Downey, CA Katherine J. Sullivan, PT, PhD University of Southern California, Los Angeles, CA

  2. Multi-site Multi-institution Visit us at: http://pt.usc.edu/clinresnet

  3. Dr. David Brown, PhD, PT Northwestern University Dr. Katherine Sullivan, PhD, PT University of Southern California Dr. Sara Mulroy, PhD, PT Rancho Los Amigos National Rehabilitation Center Lead Investigators Project Coordinator Tara Klassen, PT, NCS Intervention Therapists Evaluation Therapists Tara Klassen, PT, NCS Robbin Howard, DPT Didi Matthews, DPT Bernadette Currier, PT Nicole Furno, PTA Nicole Korda, PT Carolina Carmona, PT Arlene Yang, MPT, NCS Betsy King, MPT Craig Newsam, DPT Barbara Lopetinsky, PT Allie Hyngstom, PT Sheila Schindler-Ivens, PhD, PT Lynn Rogers, PT

  4. Specific Aims - General To determine the effectiveness of specific strength training programs to promote locomotor recovery after stroke.

  5. Interventions • Exercise Conditions: • Body-weight supported treadmill training (BWSTT) • Task-specific, repetitive practice of walking

  6. Interventions • Exercise Conditions: • Locomotor-based strength training (LBST) • Limb-loaded, pedaling exercise

  7. Interventions • Exercise Conditions: • Muscle-specific strength training (MSST) • Progressive resistive exercise for hip, knee, and ankle

  8. Interventions • Exercise Conditions: • Low intensity upper limb ergometry (SHAM) • Goal-directed, therapist supervised, aerobic activity

  9. Intervention Pairs • BWSTT/SHAM (N = 20) • Effect of BWSTT alone (task-specific strength training) • LBST/SHAM (N = 20) • Effect of LBST alone (locomotor-based strength training) • LBST/BWSTT (N = 20) • Function based strength training (combined effects of task-specific and locomotor-based strength training) • MSST/BWSTT (N = 20) • Muscle specific strength training (combined effects of task-specific and traditional PRE program)

  10. Progress to date • Final recruitment and intervention sessions • Data management • Data analysis • Dissemination and publication • Special projects • Follow up projects

  11. Recruitment Total Subject Enrollment by Month of Study *Recruitment schedule revised January 2004.

  12. Subject Demographics

  13. Data management • Data entry • Data checking

  14. Data analysis • Data survey • Data comparisons • Formal analyses

  15. STEPS Outline Phone Screen In Person Screening Evaluation Baseline Evaluation (Within 1 week pre intervention) Stratified by severity: >0.5 m/s or < 0.5 m/s Group Assignment Group A BWS treadmill and U/E cycling Group B L/E loaded cycling and U/E cycling Group C BWS treadmill and L/E loaded cycling Group D BWS treadmill and L/E weights Training = 1 hour/day x 4 days/week x 6 weeks (*BWS = body weight support) Randomization Selected Specialized Testing (20 Subjects at USC/Rancho and 20 Subjects at NWU) BWSTT Progression Data 31 subjects Mid term evaluation Post 12 treatments (3rd week) Post evaluation (Within 1 week post 24th treatment) Selected Specialized Testing (20 Subjects at USC/Rancho and 20 Subjects at NWU) Study Completed Follow up evaluation 6 month

  16. BWSTT Progression Data N = 31 subjects

  17. What are the exercise parameters that ensure a training effect? • Dose-response: • Frequency – number of training sessions in a week • Intensity – within session attributes (i.e., time in activity, level of activity) important to training specificity (i.e., strengthening, power, energy expenditure) and progression • Duration of training – total number of training sessions

  18. BWSTT: Progression • BWSTT INTERVENTION SESSION 1 • Optimal goal: • step at a treadmill speed of 2.0 mph, • up to maximum trainer assistance to enable proper gait kinematics, • body weight support between 30-40% of the subject’s weight, • four, 5 minute walking periods. • INITIAL BWSTT TRAINING PARAMETERS: • Body weight support = 30% • Treadmill speed = 2.0 mph • Trainer assistance = no assistance to maximum assistance • Proper gait kinematics = upright posture, normal values of extension/flexion of hip/knee/ankle, and coordinating limb movement to achieve symmetrical limb cadence and equal step length.

  19. BWSTT: Progression • BWSTT INTERVENTION SESSIONS 2 – 12 • Goal for training sessions 2-12 is to: • Re-train the subject’s gait at a minimum treadmill speed of 2.0 mph • With the minimum amount of body weight support • Minimum amount of trainer assistance to enable proper gait kinematics • Total of 20 minutes • Each session is started at the maximum treadmill speed, minimum body weight support and minimum amount of trainer assistance that was achieved in the previous session. • Evidence of progression in at least one of the training parameters (treadmill speed, body weight support, or trainer assistance) should be attempted in every training session.

  20. Evidence for tolerance & progression • Results from: • 31 individuals with stroke • Assigned to 1 of 3 BWSTT programs for 12 sessions

  21. Evidence for tolerance & progression • Tolerance (cardiovascular guidelines) • Resting: • SBP<180 and DBP<110 • HR <100 • SBP does not > 20 with standing • Exercise: • SBP rises to >200 mm Hg • DBP rises to >110 mm Hg • SBP drops >20 mm Hg from resting, sitting BP • HR does not exceed 80% of age predicted maximum (80% of 220-age) • Results: • One participant withdrawn: abnormal BP response to exercise. • One participant session stopped: exceeded MD recommended guideline, meds adjusted. • Several patients within guidelines but sought MD consult for hypertension management. • Progression (BWS, speed, walking time) • Significant decrease (p<.001) for all training parameters

  22. Rancho Los Amigos National Rehabilitation Center Gait Analysis Data N=20

  23. Results: Subject Characteristics

  24. Results: Subjects NotImproved Improved

  25. Results: Ankle Motion Change * * = p=0.04

  26. Results: Hip Motion Change * * * = p=0.05

  27. Puller Experiments (Mark Rogers – PI)

  28. Dissemination: Future Publications

  29. Dissemination: Other • CSM 2004, CPTA 2004, CSM 2005 • Clinical department inservices • Academic inservices • Spinoffs of Project • NIDDR Field-Initiated Grant Proposal (Brown) – pending decision • SBIR with Afferent Corp. (Brown)

  30. LEAPS Project (RCT) Locomotor Experience Applied Post-Stroke Multi-Center NCT National Institutes of Health NINDS Pamela Duncan, Ph.D., P.T., FAPTA (PI) Andrea Behrman, Ph.D., P.T. (Co-PI) University of Florida Katherine Sullivan, Ph.D., P.T. (Co-PI) Stanley Azen, Ph.D. Director DMC of PTClinResNet University of Southern California

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