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STEPS. Strength Training Effectiveness Post-Stroke Study. Multi-site, randomized clinical trial (NWU, USC, RLA) Primary Investigators: David Brown, PhD,PT; Katherine Sullivan PhD, PT; Sara Mulroy, PhD, PT Project Coordinator: Tara Klassen, MS, PT, NCS
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STEPS Strength Training Effectiveness Post-Stroke Study Multi-site, randomized clinical trial (NWU, USC, RLA) Primary Investigators: David Brown, PhD,PT; Katherine Sullivan PhD, PT; Sara Mulroy, PhD, PT Project Coordinator: Tara Klassen, MS, PT, NCS Data Management/Statistical Analysis Team: Stan Azen, PhD; Tingting Ge, MS
Background and Significance • After stroke, patients exhibit LE weakness that contributes to decreased walking velocity and endurance and contributes to disability. (Perry et al., 1995; Richards & Olney, 1996; Mulroy et al., 2003) • Post-stroke, patients respond to strengthening exercises and task-specific training to improve walking ability. (Teixeira-Salmela et al., 1999, 2001; Dean et al., 2000; Sullivan et al.,2002; Patton et al, 2004; Richards et al. 2004) • An intervention approach that combines task-specific locomotor training and LE strengthening may decrease gait-related disability and increase participation.
STEPS Research Design • Specific Aim:To determine the effectiveness of specific strength training programs to promote locomotor recovery after stroke. • Inclusion criteria: • Unilateral stroke, onset 4 months – 5 years, able to ambulate 10m 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/week x 6 weeks • Measurements: • Baseline, after 12 and 24-sessions, 6 month follow-up • Primary outcomes: gait velocity and endurance • Secondary outcomes: strength, balance, QOL
Purpose • Identify the most appropriate measures of post-stroke participation and subjective quality of life (SQOL) • Identify LE impairments (i.e.: weakness, impaired motor control, balance deficits) and activity limitations (i.e.: walking speed and endurance) that are associated with participation post-stroke. • Identify walking-related impairments and health status indicators that contribute to SQOL after stroke.
ICF Conceptual Framework:STEPS outcome measures Health Condition (STROKE) Activity Participation Body functions and structures (impairments) LE-Fugl Meyer motor score Berg Balance Score Paretic LE strength Non-paretic LE strength Walking speed (comfortable) Walking speed (fast) 6-min walk distance • SF-36 physical health • SF-36 mental health • Stroke Impact Scale (SIS) • 8 subscales • SIS-16 Overall well-being SQOL
Stroke Impact Scale (v 3.0): • Measure of post-stroke health-related function and quality of life • Stroke-specific measure developed from stroke survivors and their caregivers feedback • Captures multiple domains of activity, participation, and overall subjective impression of own recovery (Duncan et al., 1999; Lai et al., 2003) Strength Hand function ADL/IADL Mobility Physical function (SIS-16)
Demographics STEPS Participants (n = 80) Men (n=45), Women (n=35) LCVA (n=42), RCVA (n=38) Age = 60.9 ± 12.4 yrs (range 31.9 to 83.2 yrs) Stroke onset = 24.9 ± 16.2 mos
Baseline Clinical Characteristics • Comfortable velocity (10 meter walk): • 0.50 ± .28 m/s (range 0.09 – 1.17) • 6-minute walk • 184 ± 111 meters (range 17 – 442) • LE – Fugl Meyer motor score: • 23.8 ± 5.2 (range 11 – 34) • Berg Balance score • 42.6 ± 11.7 (range 9 – 56)
Univariate correlations: Activity/ impairment measures & Participation/ QOL measures
Multivariate regression models tested p < .0001 p < .0001
R2 = .43 p < .0001 Activity Participation Body functions and structures (impairments) SIS-16 LE-Fugl Meyer motor score Berg Balance Score Paretic LE strength Non-paretic strength Walking speed (comfortable) Walking speed (fast) 6-min walk distance Stepwise Multiple regression analysis: Explanatory variables for SIS-16
R2 = .50 p < .0001 Health Condition (STROKE) Activity Participation Body functions and structures (impairments) LE-FM motor score (4) Berg Balance Score LE strength (3) (paretic/non-paretic) Walking speed (comfortable) Walking speed (fast) 6-min walk distance SF-36 physical SF-36 mental (2) SIS-16 (1) Overall well-being SQOL Stepwise Multiple regression analysis: Explanatory variables for SQOL
Predictors of Subjective QOL MODEL SUMMARY
Post-Stroke Participation and QOL measures • SIS-16 and SQOL are appropriate and interpretable measures of post-stroke participation and QOL. • While the SF-36 physical and mental health components were not highly correlated to walking related impairments and activity limitations, the SF-36 mental health did reflect the importance of mental well-being in overall QOL post-stroke.
Post-stroke Participation • Walking speed and endurance, and LE motor control are important contributors to physical ability post-stroke.
QOL post-stroke • The impact of a stroke on an individual’s perception of their QOL is a reflection of: physical ability mental well-being weakness post-stroke motor control impairments
Implication for the STEPS study Will an intervention focused on improving walking ability and LE strength impact participation and SQOL in individuals post-stroke?
Rancho Los Amigos National Rehabilitation Center QUESTIONS