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Stroke is a Chronic Disease : A Need to Narrow the Gaps and Expand The Continuum of Care. Post-Acute Stroke Care. Pamela W Duncan PhD, FAPTA, FAHA Professor Division of Doctor of Physical Therapy Duke University. Stroke Care. Community. Stroke. Hyper acute. Acute. Rehab.

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Stroke is a Chronic Disease : A Need to Narrow the Gaps and Expand The Continuum of Care

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Stroke is a Chronic Disease : A Need to Narrow the Gaps and Expand The Continuum of Care

Post-Acute Stroke Care

Pamela W Duncan PhD, FAPTA, FAHA


Division of Doctor of Physical Therapy

Duke University

Stroke Care







Paul Coverdell Registry - NC

  • 13, 283 discharges with 92% NIH stroke scale > 4

  • Mean acute stay 4.9 days , Median 3 days

  • 47% discharged directly home to self care

Paul Coverdell Registry - NC

  • 13% discharged to SNF

  • 12 % discharged to Home Health

  • 14% discharged to IRF

Several Important Messages from AHA/ASA

Decade of Stroke

Stroke is Preventable

Major campaigns including Power to End Stroke


Message 2

Stroke is an emergency

CALL 911

Quality of Stroke Care Matters

GET with the Guidelines for Stroke

Paul Coverdell Registries

Developed Quality Measures for Stroke Care

JACHO Centers of Excellence For Acute Stroke Care


Stroke Care






Stroke is a chronic condition with multiple risk factors for continued decline in health, functional status and quality of life

Secondary risk factors

e.g. Hypertension, Atria Fibrillation (Anticoagulation), Diabetes), Smoking, Obesity, and Decreased Physical Activity

Post-Acute Stroke Care

Existing data suggest that fewer than 50% of individuals with stroke have their risk factors assessed, treated or controlled

90% of individuals who are overweight at initial evaluation remain overweight

51% of individuals who are hypertensive have BP under control

Smokers do not quit smoking

Few participate in exercise program

AHA Physical Activity and Exercise Recommendations- 2004

Post-Acute Stroke Care

Bushnell et al: AVAIL DATA

  • Only 75% of individuals persist with secondary prevention medications

  • Depression is under diagnosed and under treated

    • Ghost SS, Williams LS et al: Medical Care 2005


Depression is major barrier to engaging in exercise and recovery programs

Incidence of Depression range from 18 to 68%

Screen for Depression-

Geriatric Depression Measure, BECK Depression Inventory, or the CESD




Effects of Post-Stroke Depression –HUGE

Reduces Probability of Independence in ADLS

Increases Time to Recovery


  • Physical Activity In Individuals With Mild Stroke less than half of age matched individuals

    • Rand et al Stroke 2009

Death and Re-hospitalizationsBravata DM et al Stroke 2007

  • Over 53% of Medicare stroke survivors die or are readmitted to the hospital at least once during the first year after stroke

    • 27.2 % one readmission

    • 13.2 % dead –one readmission

    • 12.9 % dead

Northern Manhattan Stroke ProjectDhamoon et al Stroke 2009

The proportion of patients with functional independence after stroke declines annually for up to 5 years,

Greatest in those with no insurance and Medicaid

Independent of age, stroke severity

Even among those without recurrent stroke or MI

MMWR- November 2009Paul Coverdell Registry Across 4 States

49 % of all stroke survivors from Paul Coverdell registry are discharged requiring assistance or dependent in ambulation



e.g. >50% stroke patients unable to walk at hospital discharge

Impaired ambulation → falls, fall injuries, hospital readmission, SNF placement

Decrease cardiovascular function- deconditioning

Limited Social Participation

Post-Acute Stroke Care

Whitson, Duncan et al: JAGS 2006

Increase fractures rates in FRG 4-7 ( moderately Impaired- those who return to the community) ..first year

Kaplan-Meier Results: Time to first fracture



Estimated 1-Year Fracture Rate: 2.7% (95% CI 2.3-3.1%)

Estimated 2-Year Fracture Rate: 4.7% (95% CI 4.1-5.3%)

Results: Total FIM Score and Fracture Risk after Stroke

Discharge FIM Score <54

Discharge FIM Score >90

Discharge FIM Score 54-90

Time to first fracture (years)

Results: Total FIM Score at Discharge and Subsequent Fracture Risk

Relative Hazard of Fracture

FIM Score At Discharge


Fracture rates in this stroke cohort are 2-7 times higher than expected population rates

Characteristics associated with lower fracture risk after stroke

- high cognitive FIM scores- male gender

Stroke patients with intermediate functional impairment are more likely to fracture than those with severe or minimal impairment

Phase III, Multi-center (5), Randomized Clinical Trial

A Walking Recovery Trial

Duncan et al: BMC Neurol. 2007 Nov 8;7:39.Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial

Locomotor Experience Applied Post-Stroke (LEAPS)

Baseline Characteristics

  • 408 Community Dwelling Discharged home independent in BADLs

  • Ambulatory but less than .8 meters/sec

  • Moderate Stroke

    • 99.5% Rankin 2,3,4

Baseline at 2 Months Post-stroke



  • 62 ±12.7 mean age

  • 45.1% Female

  • 22.1% Black or African American

  • 83% Ischemic

  • 99.5% Modified Rankin 2-4

  • 63.8 days post-stroke at randomization

  • Mean walking speed = 0.38 ± 0.22 m/s

  • 53.4% severe impairment (< 0.4 m/s)

  • 46.6% moderate impairment (0.4 < 0.8 m/s)

  • Median Number of DailySteps 1738 (708-3483)

Timed Walking Tests

Practical Application

10 Meter Walk

408 Randomized 2010

0.2 m/s

0.38 m/s





Gait Speed in Meters/Second

Two Month Baselinen = 384

  • Number of steps taken in day

    • 1738 – range 708 to 3483

    • How many steps should one take a day for health and fitness

Timed Walking Tests

Practical Application

6 Minute Walk

408 randomized


Avg. gait distance at 2 Months

125 Meters

332 Meters (1089 ft.)

Minimum distance for comm. re-entry



Distance in Meters

LEAPS DATASummary of Falls Post Randomization

Risk of Hip/Femur Fracture


Pouwels et al: Stroke 2009

2 fold increase of risk of hip fracture

Highest risk within 3 months of stroke

Need to implement fall risk management in transitions and in community programs


Exercise Duration

Maximum METs Achieved




2 months post stroke individuals discharged home ambulatory

They do not walk much

They have limited aerobic capacity

They have high risk for falls and fractures


Current Model





Mobility Limitation

(Gradual Onset)

Mobility Limitation

(Sudden Onset)

Age in Years



Actual Model



Mobility Limitation

(Sudden Onset)

Age in Years

Stroke is A CHRONIC Disease


Strategies for Optimizing Function

Management of Co-morbid Conditions

Secondary Risk Factors

Recovery not simply neurorehabilitation

More aggressive rehabilitation and recovery program- and they may not have to be high-tech



Cochrane Reviews (2003, 2007): Efficacy of extended home-based rehabilitation programs and physiotherapy in improving functional independence following stroke

50% of patients with limited ambulation have meaningful improvement in LE strength and gait velocity with post-acute stroke rehabilitation

Stroke patients can improve their cardiovascular function /endurance

Post-Acute Stroke Care




MAY 26, 2011

Body-Weight–Supported Treadmill

Rehabilitation after Stroke

Pamela W. Duncan, P.T., Ph.D., Katherine J. Sullivan, P.T., Ph.D.,

Andrea L. Behrman, P.T., Ph.D., Stanley P. Azen, Ph.D., Samuel S. Wu, Ph.D.,

Stephen E. Nadeau, M.D., Bruce H. Dobkin, M.D., Dorian K. Rose, P.T., Ph.D.,

Julie K. Tilson, D.P.T., Steven Cen, Ph.D., and Sarah K. Hayden, B.S.,

for the LEAPS Investigative Team

Multi-site Phase III Randomized Trial of Physical Therapy Interventions to Improve Walking Recovery Post-stroke

Pamela W Duncan PhD, PT, FAPTA, FAHA

Principal Investigator

Andrea L Behrman PhD, PT, FAPTA

Co-Principal Investigator

Katherine J Sullivan PhD, PT, FAHA

Co-Principal Investigator

for the LEAPS Investigative Team

Funding from National Institute of Neurological Disorders and Stroke and the National Center for Medical Rehabilitation Research

Trial registration: NCT00243919

Why a Trial in Walking Recovery?

  • Stroke mortality is decreasing, yet stroke remains the leading cause of acquired disability in adults.

    Roger VL, et al. Heart Disease and Stroke Statistics – 2011 Update: a Report from the American Heart Association.

    Heidenreich J et al. Circulation 2011;123:e18-209

  • Two-thirds of individuals with stroke have significant limitations in walking.

  • Jorgensen HS, et al. Recovery of Walking Function in Stroke Patients: The Copenhagen Stroke Study. Arch Phys Med Rehabil 1995; 76(1):27-32

  • 75% of stroke survivors fall within six months of the stroke.

    Weerdesteyn V, et al. Falls in Individuals with Stroke. JRRD 2008; 45(8):1195-2014

  • Hip fracture risk is doubled after a stroke.

    Pouwels S, et al. Risk of Hip/Femur Fracture after Stroke. Stroke2009; 40:3281-3285

  • Walking Speed Predicts Levels of Function and Survival Perry J, et al. Classification of Walking Handicap in the Stroke Population. Stroke 1995; 26:982-989 Schmid A, et al. Improvements in Speed-based Gait Classifications are Meaningful. Stroke 2007; 38:2096-2100

    • Community mobility requires walking speed > 0.8 m/s

      (0.8 m/sec =1.8 mph)

    • Short community walks are feasible at 0.4 - 0.8 m/s

      (0.4m/sec=.09 mph)

    • Walking is limited to the home at <0.4 m/s

    • Walking speed is associated with survival in older adults

      Studenski S, et al. Gait Speed and Survival in Older Adults. JAMA 2011; 305(1):50-58

    Why this Trial?

    A body weight support and treadmill system is an emerging modality to improve walking but there is:

    • Limited evidence to support its value

      Cochrane Review 2002 & Cochrane Review 2005

    • Lack of practice guidelines for training

    • Appropriate dosing and timing of interventions after stroke are unknown

    • Growing consensus in clinical practice

      • that repetitive and progressive practice of stepping using supported treadmill systems is effective

    • Growing commercial market for BWS treadmill systems and robotic-assisted treadmill steppers

    Study Goals

    LEAPS was designed to determine:

    • If in addition to Usual Care, a walking training program that includes BWST (LTP) is superior to a home physical therapy program that focused on structured, progressive strength and balance exercises (HEP).

    • If the timing of intervention delivery for LTP (Early at 2 months after stroke vs. Late at 6 months after stroke) effected recovery.

    • If degree of initial walking impairment (Moderate vs. Severe) effected response to the interventions.

    Interventions1.5 hrs, 3x/wk, 12 wks, structured & progressive programs

    Locomotor Training Program

    Home Exercise Program

    • 20-30 min at 2 mph on TM with BWS

    • Progression: endurance, speed, BWS, independence, adaptability

    • Followed by walking practice off the treadmill

    • 2-3:1 therapist/patient

    • Strength exercises

    • Balance exercises

    • Progression: repetitions, activity, balance challenge, resistance

    • Encouragement to walk daily

    • 1:1 therapist/patient

    Primary Outcome Measure

    LEAPS trial definition of “improved functional level of walking ability”


    1 year after stroke


    > 0.4 m/s

    < 0.4 m/s

    > 0.8 m/s


    > 0.4 m/s < 0.8 m/s

    • Perry J, et al. Classification of Walking Handicap in the Stroke Population. Stroke 1995; 26:982-989 Schmid A, et al. Improvements in Speed-based Gait Classifications are Meaningful. Stroke 2007; 38:2096-2100

    Prospective enrollment

    5 - 45 days post-stroke

    Initial contact & preliminary screening from inpatient rehab

    Research Design

    Intervention Type: LTP compared to Control (HEP)

    Intervention Time: LTP at 2-months or at 6-months post-stroke


    training initiated

    @ 2 mos

    N = 120

    Subject Recruitment

    • From April 2006 - June 2009

    • From 6 inpatient rehabilitation facilities in Florida and California

      • Brooks Rehabilitation Hospital, Jacksonville, FL

      • USC PT Associates, Los Angeles, CA and Centinela Freeman Hospital, Inglewood , CA

      • Florida Hospital, Orlando, FL

      • Long Beach Memorial Hospital, Long Beach, CA

      • Sharp Rehabilitation Center, San Diego, CA

      • Rancho Los Amigos National Rehabilitation Center, Los Angeles, CA

    Primary Inclusion / Exclusion Criteria

    • Inclusion

    • Age ≥ 18 years

    • Stroke within 45 days and living in the community at 2 months post-stroke

    • Residual paresis in the lower extremity

    • Ability to walk 10 feet with no more than 1-person assistance

    • Self-selected 10 meter walking speed less than 0.8 m/s

    • Physician approval for participation

    • Passed an exercise tolerance test


    • Dependent in ADLs prior to stroke

    • Pre-existing neurological disorders

    • Multiple co-morbidities that would be contraindications for exercise programs

    • Inability to travel to treatment site

    • Walking equal to or faster than 0.8 m/s

    Baseline at 2 Months Post-stroke



    • 62 ±12.7 mean age

    • 45.1% Female

    • 22.1% Black or African American

    • 83% Ischemic

    • 99.5% Modified Rankin 2-4

    • 63.8 days post-stroke at randomization

    • Mean walking speed = 0.38 ± 0.22 m/s

    • 53.4% severe impairment (< 0.4 m/s)

    • 46.6% moderate impairment (0.4 < 0.8 m/s)

    • Median Number of DailySteps 1738 (708-3483)

    Hypothesis 1

    1 year after stroke, both the LTP-early and LTP-late groups would have a higher proportion of participants who improved functional level of walking than would the home exercise group (HEP).

    Functional Outcome by Group at 12-months

    Hypothesis 2

    Improvements in walking speed from baseline to 1-year after stroke for LTP subjects trained at 2 months will be significantly greater than for subjects trained at 6 months.


    • Early-LTP mean change in comfortable walking speed was 0.23±0.20 m/s

    • Late-LTP mean change in comfortable walking speed was 0.24±0.23 m/s

    • No significant interaction between baseline severity of walking impairment and timing of LTP for walking speed at 1 year

    Walkingspeed trajectory by intervention group and severity at screening, 2-(baseline), 6-, and 12-months post-stroke*

    * Screening at 26.0±11.6 days post-stroke. 2-month baseline = point of randomization. The bars indicate 95% confidence interval.

    Walkingspeed trajectory by intervention group and severity at screening, 2-(baseline), 6-, and 12-months post-stroke*

    * Screening at 26.0±11.6 days post-stroke. 2-month baseline = point of randomization. The bars indicate 95% confidence interval.

    Walking Speed at 6 Months

    • Six months after stroke, Early-LTP (0.25±0.21 m/s) and HEP (0.23±0.20 m/s) groups had similar gains in walking speed and both groups sustained these gains at 1 year.

    • The Late-LTP group (which only received usual care from 2 to 6 months) improved by 0.13±0.14 m/s at 6 months.

    Statistically and Clinically Significant Changes in Outcomes from 2 mos to 12 mos post-stroke

    No differences in improvements across treatment groups

    HIGHLY clinically relevant improvements

    Preplanned Secondary Analysis of 6 Month Outcomes

    Late-LTP (usual care) experienced approximately HALF

    the improvement of early intervention groups

    Proportion Who Improved Functional Level of Walking at 6 Months

    6-mo outcomes

    Proportion change

    Gait speed change

    What comprises usual care visits in 2-6 mos post-stroke for patients with moderate to severe walking disability?

    For 408 total:

    Median number of PT visits = 10.5, [0 to 86 visits)

    For LTP

    Median number of PT visits = 7, [0-56]

    For HEP

    Median number of PT visits = 13, [0-86]

    For Usual Care only

    Median number of PT visits = 11, [0-69]

    # of UC PT visits did not have an effect on walking speed outcomes for the LTP and HEP groups (p=0.287).

    # of UC PT visits for UC-only group did have a positive association with walking speed change adjusting for age and baseline walking speed HEP groups (p=0.049).

    Related Serious Adverse Events

    • 10 related serious adverse events

    • 9 occurred during intervention

      • 3 (2.2%) in early LTP

      • 5 (3.5%) in late LTP

      • 2 (1.6%) in HEP

    Hospitalizations were for

    CV symptoms or blurred vision

    9 of the 10 participants with related SAEs returned to intervention

    Minor Adverse Events

    • 56% of participants reported minor adverse events

    • LTP groups reported more events of dizziness and faintness during intervention

      • Early LTP 7.9%

      • Late LTP 5.6%

      • HEP 0%

    Falls and Falls Rate

    The most common minor adverse event was falls

    • 57.6% of individuals experienced 1 fall

    • 34% experienced multiple falls

    • 6% experienced an injurious fall

    • More multiple falls in early-LTP group than late-LTP or HEP (p<0.07)

      • Attributable to more multiple fallers in the severe group receiving early-LTP (p< 0.02)


    • ALL 129 (32%)

    • ELTP 45 (32.4%)

    • LTPT 53 (37.1 %)

    • HEP 31 (24.6 %)

    • P= 0.09

    Conclusions - Primary Analysis

    • We did not establish the superiority of locomotor training that included BWS on a treadmill over rigorous, progressed, equally dosed, home based physical therapy.

    • The home exercise program had fewer risks.

    • The rate of falls suggests that as participants increase mobility and physical activity they fall more. Clinically, this suggests that we should partner our mobility training with more aggressive falls prevention management.

    Conclusions - Secondary Analysis 6 months

    • Both programs are effective forms of physical therapy, and at 6 months both are superior to usual care provided according to current practices.

    • The patients in the late Locomotor Training Program group made significant improvements in walking speed, despite the widely held assumptions and reports that most functional improvements after stroke are complete by six months.

    • The number needed to treat (NNT) to yield one additional subject making a transition to a higher functional walking level is 5.8 for HEP and 5.5 for LTP.

    Patients recover faster and sustain recovery when the intervention is given early.

    LEAPS: in the context of EBP

    • For patients in the first year post-stroke who can walk 10 feet but are not walking at speeds >0.8 m/s (1.8 mph):

    • This randomized trial provides strong and high quality evidence that:

    • Structured progressive locomotor training (including BWSTT) is not superior to an equally rigorous structured strengthening and balance exercise program for walking recovery.

    • Either program is more effective than usual care at 6 months after stroke.

    • Both interventions have low risks of adverse events, but a structured exercise program in the home results in fewer adverse events compared to locomotor training.

    HEP May Be More Accessible and Feasible

    Hypothesis 1:

    The functional walking ability (successful recovery of walking ability, walking speed, endurance) will be greater with extended training (increasing dose intervals of 12, 24, and 36 sessions) across all intervention groups.


    • Across all groups, 43% of completers “leaped” a functional level of walking ability by 12 sessions.

    • 13% more “leaped” by 24 sessions.

    • 7% more “leaped” by 30-36 sessions.

    Getting Beyond the PlateauJ Rimmer- University of Illinois

    Rehabilitation Setting


    Rehabilitation Center

    Long-Term Care Facility

    Outpatient Medical Center


    Transitional Setting

    University-Based Clinic

    Hospital Wellness Facility

    Private Clinic

    Work-Related Facility

    Community Setting

    Home Program

    Fitness Center

    Recreation Facility

    Senior Center

    Community Exercise


    Screening for Stroke-Related Impairments Balance, Gait, Exercise Tolerance

    Low risk for Falls and can Exercise Independently

    Moderate/High risk for Falls or cannot Exercise Independently

    Community Wellness Program

    Physical Therapy Evaluation

    LE motor control and sensation, endurance, balance self-efficacy

    Mild impairment

    Moderate impairment

    Physical Therapy

    Gait, balance training, Ther Ex, orthotic/assistive device evaluation

    Supervised Exercise Program with PTA/Technician


    Community Wellness Programs

    • After discharge from formal rehabilitation, many deficits remain so availability of accessible community-based wellness programs are essential

    • Example:



    Empoli Italy

    Geriatrician- Empoli Helath District- Manages Community Based Programs and Rehabilitation

    Develop Best Practice Models with His Rehab Provider

    Established Community Based Programs

    Established clinically relevant data bases by measuring outcomes

    Support of Italian Health Ministry


    APA in ASL 11 - Tuscany



    Start: 10.12.2003

    Courses: 251

    Regular attendance >4200


    Cerreto Guidi

    Capraia e Limite



    S. Croce S.A.





    S. Miniato




    Parkinson (10)

    FP & Chronic Back Pain (177)

    Stroke (29)


    Coordination Center

    Lower Limbs in Water (35)

    Community settings

    Multiple providers (no-profit and profit)


    Low cost covered by the participants


    Preliminary study - Short Physical Performance Battery

    APA group

    Control group

    Repeated chair standing


    (Groups: NS, Phases: NS, G*P: P<0.0001)

    (Groups: 0,029, Phases: NS, G*P: NS)


    Sumary performance score

    (Groups: NS, Phases: NS, G*P: P<0.0001)

    (Groups: NS, Phases: NS, G*P: P<0.0001)


    Hamilton Depression Scale – 1 year follow up

    Included only individuals with

    depressive symptoms (HDS >8)

    * t – test, p < 0.016, T0-T6 e T0-T12

    No differences between T6 and T12


    Macko et al: JRRD , 325-328, 2008

    Adaptive physical activity improves mobility function and quality of life in chronic hemiparesis- A MODEL from ITALY


    Sustained Model




    Mobility Limitation

    (Sudden Onset)

    Community Wellness Programs/intermittent re-assessment

    Age in Years


    Message 4

    • We can add quality of life to stroke survival

    What are the implications for Comprehensive Systems of Care for Stroke.

    Improve transitions in care from acute care to primary care, rehabilitation, and community based programs

    Expand stroke registries , get with the guidelines and quality improvement initiative thru the continuum of care

    Case management at community level for recovery, management of disability, prevention of secondary complications

    • Create wellness programs/ physical activity programs for those with stroke-


    integration AND

    Transitions In Care For






    Home Environment


    EPC/ Guidelines/Policy


    Guiding Principles

    Empowerment of patients and families

    Interdisciplinary and Community l Collaborations

    Evidence informed practice



    Appropriateness of individuals



    Health System

    Capacity Building




    Quality Performance

    Social / Community

    Reduce Rehosptializations

    Improved Functional Outcome, Improved Patient Satisfaction

    Community Partners and Programs

    Academia / Institutes


    Programs & Interventions

    Network of Researchers,

    Health System Leaders,

    Community Partners







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