Lead Investigators : David A. Brown, PT, PhD Northwestern University, Chicago, IL

1. STANDARDIZED EXERCISE REGIMENS FOR THE STEPSPROJECT: FINDING THE STARTING POINT & PROGRESSING FORWARD COMBINED SECTIONS MEETING 2005 New Orleans, LA February 23-27, 2005 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. 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

3. Background and significance: • Post-stroke, muscular weakness contributes to decreased walking velocity and endurance, and increased disability. Perry et al., 1995; Richards & Olney, 1996; Mulroy et al., 2003 • Lower extremity strengthening exercises and task-specific training result in improved walking ability in individuals post-stroke. Teixeira-Salmela et al., 1999; Sullivan et al., 2002; Patton et al, 2004 • No studies have examined the combined effect of task-specific training with strength training, or the effect of different strengthening protocols on gait outcomes.

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

5. STEPS Interventions: • Standardized • Structured intervention based on principles of exercise (i.e.,specificity, intensity, progression) • Controlled frequency (4x/wk) and duration (6 wks) • Combined task-specific training with strength programs that can be used by physical therapist in the clinic.

6. STEPS Research Design: • Inclusion criteria • Unilateral stroke, onset 4 mos – 5yrs, able to ambulate 10 m with/without assistive device with no more than standby assist, slower than before stroke • Recruitment goal: • 80 individuals across 3 clinical sites • Intervention parameters: • 24 sessions, 4 days/wk, 6 wks • Measurements: • Baseline, after 12- and 24-sessions, 6 mos follow-up • Primary outcome: gait velocity and endurance (10m and 6-min walk) • Secondary outcomes: LE strength, balance, QOL

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

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

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

10. Interventions • Exercise Conditions: • Low intensity upper limb ergometry (SHAM)

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

12. 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

13. BWSTT: Evidence from the literature • 40% BWS decreased over training more effective. Visintin et al., 1998 • Faster speeds (≥2.0 mph) more effective. Sullivan et al, 2002; Pohl et al., 2002 • 4-5 min bouts (20 total min) at faster speeds can be tolerated by patients with chronic stroke. Sullivan et al, 2002; Pohl et al., 2002 • Minimum of 12 sessions to get training effect. Sullivan et al, 2002

14. 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.

15. 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.

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

17. 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

18. MSST: Evidence from the literature • Increase in lower extremity muscle strength without adverse increase in spasticity. Brown & Kautz, 1998; Teixeira-Salmela et al., 1999; Sharp & Brouwer, 1997 • Increase in lower extremity strength and functional ability. Weiss et al., 2000; Teixeira-Salmela et al., 1999, 2001 • Wide variability in type of exercises, frequency, duration, and intensity of programs. • No post-stroke studies have accounted for the effects of synergistic movement when designing a strength program; further research required to determine most suitable strength training protocol for individuals post-stroke.

19. MSST: Progression • Each exercise for the muscle group begins with specifically targeting the isolated muscle(s). Therefore, the baseline exercise position requires the patient to move in an antigravity range, deviating from synergy. • If the patient cannot perform the movement deviating from synergy, a decrease in progression will be recommended that incorporates movement patterns within synergy. • If the patient can complete the antigravity movement that deviates from synergy, then progressive resistive loading will begin from this position.

20. Example of Hip Extensor exercise progression:

21. Hip Extensors NO Exercise 1A Progression Is the patient able to perform 10 repetitions? Exercise 1A: Standing Hip Extension Is the patient able to perform 10 repetitions? YES NO Exercise 1B: Single-limb bridge with non-paretic limb flexed Is the patient able to perform 10 repetitions? YES Exercise 1B Progression Is the patient able to perform 10 repetitions? NO YES NO Exercise 1C: Single-limb bridge with non-paretic limb extended Is the patient able to perform 10 repetitions? YES Exercise 1C Progression Is the patient able to perform 10 repetitions? NO YES NO YES Exercise 1D: Bilateral Bridge Is the patient able to perform 10 repetitions? Exercise 1D Progression Is the patient able to perform 10 repetitions? NO YES NO YES NO Exercise 1E: Active Assisted Bilateral Bridge Is the patient able to perform 10 repetitions? Exercise 1E Progression Is the patient able to perform 10 repetitions? YES

22. Exercise 1A Standing Hip Extension Is the patient able to perform 10 repetitions? NO Exercise 1B Single-limb bridge with non-paretic limb flexed Is the patient able to perform 10 repetitions? YES Exercise 1B Progression Is the patient able to perform 10 repetitions? NO YES

23. Evidence for MSST progression: • Results from: • 10 participants

24. STEPS exercise protocols: • Developed with best available evidence. • BWST and MSST tolerated by individuals with chronic stroke with evidence of exercise progression. • Available at: http://pt.usc.edu/clinresnet/

25. References Kautz SA, Brown DA. Relationships between timing of muscle excitation and impaired motor performance during cyclical lower extremity movement in post-stroke hemiplegia. Brain 121 ( Pt 3):515-26, 1998. Mulroy S, Gronley J, Weiss W, Newsam C, Perry J. Use of cluster analysis for gait pattern classification of patients in the early and late recovery phases following stroke. Gait & Posture 18(1):114-25, 2003. Patten C, Lexall J, Brown H. Weakness and strength training in persons with poststroke hemiplegia: Rationale, method, and efficacy. Journal of Rehabilitation Research & Development 2004; 41(3A):293-312. Perry J, Garrett M, Gronley JK, Mulroy SJ. Classification of walking handicap in the stroke population. Stroke 1995; 26(6):982-989. Pohl MM. Speed-dependent treadmill training in ambulatory hemiparetic stroke patients: a randomized controlled trial. Stroke 33(2):553-8, 2002.

26. Richards CL, Olney S. Hemiparetic gait following stroke: Part II Recovery and physical therapy. Gait and Posture 1996; 4:149-162. Sharp SA, Brouwer BJ. Isokinetic strength training of the hemiparetic knee: effects on function and spasticity. Arch Phys Med Rehabil 1997; 78(11):1231-6. Sullivan K, Knowlton B, Dobkin B. Step training with body weight support: Effect of treadmill speed and practice paradigms on poststroke locomotor recovery. Archives of Physical Medicine and Rehabilitation 2002; 83(5):683-691. Teixeira-Salmela LF, Olney SJ, Nadeau S, Brouwer B. Muscle strengthening and physical conditioning to reduce impairment and disability in chronic stroke survivors. Arch Phys Med Rehabil 1999; 80(10):1211-1218. Visintin M, Barbeau H, Korner-Bitensky N, Mayo NE. A new approach to retrain gait in stroke patients through body weight support and treadmill stimulation. Stroke 1998; 29(6):1122-8. Weiss A, Suzuki T, Bean J, Fielding RA. High intensity strength training improves strength and functional performance after stroke. American Journal of Physical Medicine & Rehabilitation 79(4):369-76; quiz 391-4, 2000;-Aug.