Activating Behavior for Lasting Engagement After Stroke
Phase: NA
Conditions: Stroke, Physical Activity, Sedentary Lifestyle, Behavior, Health, Physical Disability
Sponsor: University of Pittsburgh

Page 1 of 7 
 
Study Protocol  
 
 
 
 
 
 
Official Title: Activating Behavior for Lasting Engagement After 
Stroke (ABLE) 
  
 
 
ClinicalTrials.gov ID (NCT number): 03305731 
 
 
 
Protocol Date: August 29, 2018 
 
 
 
 

Page 2 of 7 
 
Scientific Background 
Approximately 795,000 Americans sustain a stroke each year, placing these individuals at risk 
for recurrent stroke. One goal of post-acute rehabilitation and medical management of stroke is 
to reduce the risk for recurrent strokes. Reducing the risk for recurrent stroke is routinely 
approached by promoting health behaviors that mitigate specific risk factors for stroke. Specific 
health behaviors that are important for managing these risk factors include adherence to 
medication routines, smoking cessation, and physical activity. 
 
Physical inactivity throughout the day can lead to cardiovascular risk factors for recurrent stroke. 
Prolonged time spent physically inactive, or sedentary, has been identified as a distinct risk 
factor for poor metabolic control, weight management, and all-cause mortality among adults, 
after controlling for time spent engaged in exercise. Sedentary time that is accumulated in 
prolong bouts with few sedentary breaks is associated with risks to cardio-metabolic health. 
Modifying sedentary behavior patterns after stroke may, therefore, modify cardio-metabolic risk 
factors for recurrent stroke. Promoting participation in daily life activities frequently requires 
individuals to move out of a seated or reclined position and may support the modification of 
sedentary behavior patterns after stroke. 
 
Subtle impairments in cognitive functions are common after stroke. These impairments can lead 
to difficulty monitoring one’s behavior to overcome barriers (e.g. balance impairments), and 
achieve participation-related goals after stroke. Difficulty monitoring and adjusting behavior, 
may lead to abandonment of daily life activities that require a high level of physical function 
(e.g. shopping at the grocery store) rather than identifying alternative strategies to return to 
participation in that activity (e.g. pushing the cart and planning short trips to the grocery store). 
When daily life activities are abandoned, they may be replaced with sedentary behavior (e.g. 
watching television at home while a caregiver shops for groceries). 
 
Behavioral activation is an intervention approach that provides explicit structure for self-
monitoring behavior. Behavioral activation approaches have been applied among clients with 
depression, dementia, brain injury, and stroke. Improvements in mood and cognitive functions 
and reduction in disability have been associated with behavioral activation interventions. We 
designed an intervention based in behavioral activation to provide explicit structure for 
monitoring and adjusting behavior to achieve participation in daily life activities that may break 
up sedentary time after stroke. Our intervention, the Activating Behavior for Lasting 
Engagement (ABLE) intervention, applies activity scheduling and monitoring and collaborative 
problem solving to client-selected goals. The ABLE intervention holds promise to promote 
participation in daily life activities at scheduled times throughout the day to break up long bouts 
of sedentary time. 
 
Study Objectives 
The purpose of this research study is to assess the feasibility and estimate the effects of a 
behavioral intervention (the Activating Behavior for Lasting Engagement intervention, ABLE) 
on sedentary behavior after stroke. 
 

Page 3 of 7 
 
Research Question: What are the effects (sedentary behavior, participation levels) of the ABLE 
intervention in the chronic stroke population at post-intervention (week 10) and follow-up (week 
18)? 
HYPOTHESIS A: The ABLE intervention will be associated with less sedentary time 
accumulated in prolonged bouts over time (ActivPAL). 
HYPOTHESIS B: The ABLE intervention will be associated with a greater number of sedentary 
breaks over time (ActivPAL). 
HYPOTHESIS D: The ABLE intervention will be associated with greater participation over time 
(Stroke Impact Scale-Participation Subscale). 
 
Study Design & Methods 
The study is a single-group quasi-experimental study that will estimate within-group effects of 
the ABLE intervention on sedentary behavior. All assessment at intervention procedures will be 
completed by trained research staff (research assistants, interventionists) with supervision 
provided by the principal investigator. 
 
Screening Procedures: 
Participants who verbalize interest in the ABLE study over the telephone will be asked to answer 
questions over the phone regarding their medical history, age, mobility, daily activities 
(Sedentary Behavior Questionnaire), and location of residence. These questions will determine 
initial eligibility. 
 
If, based on telephone screening, participants are eligible and continue to indicate interest, an in-
person session will be scheduled to review the full informed consent. This session will be 
completed in the participant's home. After participants have completed the informed consent 
process, we will complete standardized clinical assessments (PRIME-MD/MINI, Patient Health 
Questionnaire-9) to determine eligibility. Participants will complete the PRIME-MD/MINI and 
Patient Health Questionnaire-9 to screen for mood. These are valid and reliable screening 
measures (Gilbody et al., 2007; Kroenke, et al., 2002; Spitzer et al., 1999). 
 
Baseline Assessment Procedures: 
Participants who provide informed consent, complete screening procedures, and are found to be 
eligible based on our eligibility criteria will then complete Baseline 1.  
 
BASELINE 1 ASSESSMENTS 
 
Demographic (age, gender, race, ethnicity, education, vocation, pre-stroke residential status and 
social support), medical (stroke etiology and date of onset, co-morbidities, medications), and 
rehabilitation history (type and duration) will be gathered via participant interview and medical 
record review. 
 
Self-Administered Comorbidity Questionnaire is a participant-reported measure of 
comorbidities. Participants are asked to report on the presence or absence of specific chronic 
diseases, if they receive treatment for the disease, and if the disease interferes with their daily life 
activities. 
 

Page 4 of 7 
 
The Stroke Impact Scale-Participation Subscale is a valid and reliable measure of self-reported 
engagement in community activities. Participants are asked to rate the degree to which they feel 
restricted in 10 types of participation on a 1 to 5 Likert-type scale. Scores are summed and 
converted to a 0 to 100 scale where 100 indicates no participation restrictions. 
 
ActivPAL(TM) monitors will be used to assess sedentary behavior and step count over 7 days. 
The ActivPAL is a small, lightweight monitor that quantifies time spent in sitting, reclined, 
standing, and stepping. The participant will be provided the "ActivPAL Guide" as a reference 
guide. We will follow a 24-hour wear protocol in which the participants will wear the device on 
their thigh for 7 days. During the BASELINE 1 assessment session, the researcher will train the 
participant on appropriate care and use of the device. The ActivPAL will be waterproofed and 
fastened to the individual's thigh using a non-latex, gentle adhesive (Tegaderm). Participants will 
also be asked to record their bedtime and waking time in the "ActivPAL Diary". Sedentary 
bouts, sedentary breaks, and steps per day will be assessed using the ActivPAL monitor. 
 
BASELINE 2 ASSESSMENTS 
 
BASELINE 2 assessments will be conducted after a 4-week delay. Due to the nature of our 7-
day ActivPAL(TM) monitoring, BASELINE 1 occurs during week 1 of the study. The 4-week 
delay is a time period that we dose-matched to the intervention period, in which there is no 
intervention and no activity monitoring occurs. This occurs during weeks 2-5 of the study. 
BASELINE 2 assessments described below will occur during week 6 of the study. 
Questionnaires will be asked over the telephone, and a researcher will meet the participant at 
their home to initiate one week of ActivPAL(TM) monitoring as described below. (Estimated 
participant time: 60 minutes) 
 
ActivPAL(TM) monitors will be used to assess sedentary behavior and step count over 7 days. 
Participants will be provided with the "ActivPAL Guide" as a reference guide. The ActivPAL is 
a small, lightweight monitor that quantifies time spent in sitting, reclined, standing, and stepping. 
We will follow a 24-hour wear protocol in which the participants will wear the device on their 
thigh for 7 days. During the BASELINE 2 assessment session, the researcher will train the 
participant on appropriate care and use of the device. The ActivPAL will be waterproofed and 
fastened to the individual's thigh using a non-latex, gentle adhesive (Tegaderm). Participants will 
also be asked to record their bedtime and waking time in the "ActivPAL Diary." Sedentary 
bouts, sedentary breaks, and steps per day will be assessed using the ActivPAL monitor. 
 
The Stroke Impact Scale-Participation Subscale is a valid and reliable measure of self-reported 
engagement in community activities. Participants are asked to rate the degree to which they feel 
restricted in 10 types of participation on a 1 to 5 Likert-type scale. Scores are summed and 
converted to a 0 to 100 scale where 100 indicates no participation restrictions. 
 
ABLE Intervention Procedures 
 
Once participants have completed baseline testing procedures, they will participate in up to 12 
intervention sessions. These sessions will be delivered by a rehabilitation professional who has 
experience in stroke rehabilitation. Each intervention session will last approximately 45 minutes. 

Page 5 of 7 
 
The sessions will occur at the participant's home or at a participant-preferred location in the 
community. 
 
ABLE INTERVENTION: Intervention sessions may be video recorded. During the first 
intervention session, the participant will describe a typical weekday, Saturday, and Sunday 
through a semi-structured interview and the "Intervention: Daily Schedule Worksheet." During 
this process, the therapist will ask the participant to identify portions of the day in which they 
spend prolonged amounts of time in a seated position. Participants will be oriented to the 
importance of breaking up sitting time into shortened bouts throughout the day using 
participation in meaningful daily life activities. Participants will then complete the Activity Card 
Sort to identify meaningful daily life activities that could be incorporated throughout the day and 
week to break up prolonged sedentary time. These activities will be documented in the 
participant's workbook. 
 
Subsequent intervention sessions will focus on scheduling and monitoring participation in daily 
life activities during times of the day or during activities in which prolonged bouts of sitting time 
were identified. The sessions will focus around specific time periods that were identified (e.g. 
every day after lunch, the participant spends 3 hours seated in the recliner) or specific activities 
in which the participant identifies prolonged sitting time (e.g. while watching television). The 
participant will select an activity and the therapist will collaborate with the participant to identify 
strategies for using this activity to break up prolonged seated time. The participant will use a 
worksheet to schedule the activities and develop a plan for self-monitoring. During the following 
intervention sessions, the therapist and participant will review the planned schedule and identify 
successes and barriers to these activities. The participant and therapist will collaboratively 
generate solutions to identified barriers and a revised plan will be established. 
 
The intervention therapist will document intervention sessions on the "Intervention: Session 
Notes" document. 
 
After completion of 12 intervention sessions, participants will complete post-intervention 
assessments and activity monitoring. 
 
Post-Intervention Assessment Procedures 
 
ActivPAL(TM) monitors will be used to assess sedentary behavior and step count over 7 days. 
Participants will be provided with the "ActivPAL Guide" as a reference guide. The ActivPAL is 
a small, lightweight monitor that quantifies time spent in sitting, reclined, standing, and stepping. 
We will follow a 24-hour wear protocol in which the participants will wear the device on their 
thigh for 7 days. During the BASELINE 2 assessment session, the researcher will train the 
participant on appropriate care and use of the device. The ActivPAL will be waterproofed and 
fastened to the individual's thigh using a non-latex, gentle adhesive (Tegaderm). Participants will 
also be asked to record their bedtime and waking time in the "ActivPAL Diary." Sedentary 
bouts, sedentary breaks, and steps per day will be assessed using the ActivPAL monitor. 
 
The following questionnaire will be conducted via the telephone: 
The Stroke Impact Scale-Participation Subscale is a valid and reliable measure of self-reported 

Page 6 of 7 
 
engagement in community activities. Participants are asked to rate the degree to which they feel 
restricted in 10 types of participation on a 1 to 5 Likert-type scale. Scores are summed and 
converted to a 0 to 100 scale where 100 indicates no participation restrictions. 
 
Follow-Up Assessment Procedures (8 weeks post-intervention) 
 
ActivPAL(TM) monitors will be used to assess sedentary behavior and step count over 7 days. 
Participants will be provided with the "ActivPAL Guide" as a reference. The ActivPAL is a 
small, lightweight monitor that quantifies time spent in sitting, reclined, standing, and stepping. 
We will follow a 24-hour wear protocol in which the participants will wear the device on their 
thigh for 7 days. During the BASELINE 1 assessment session, the researcher will train the 
participant on appropriate care and use of the device. The ActivPAL will be waterproofed and 
fastened to the individual's thigh using a non-latex, gentle adhesive (Tegaderm). Participants will 
also be asked to record their bedtime and waking time in the "ActivPAL Diary." Sedentary 
bouts, sedentary breaks, and steps per day will be assessed using the ActivPAL monitor. 
 
The following questionnaire will be conducted via the telephone: 
The Stroke Impact Scale-Participation Subscale is a valid and reliable measure of self-reported 
engagement in community activities. Participants are asked to rate the degree to which they feel 
restricted in 10 types of participation on a 1 to 5 Likert-type scale. Scores are summed and 
converted to a 0 to 100 scale where 100 indicates no participation restrictions. 
 
Eligibility Criteria  
Inclusion Criteria: 
1) diagnosis of ischemic or hemorrhagic stroke 
2) ≥6 months and ≤5 years post-stroke 
3) ≥18 years of age 
4) ambulatory in the community with or without an assistive device (e.g. walker, cane) 
5) self-reported sedentary behavior (≥6 hours/day of sedentary behavior reported using the 
Sedentary Behavior Questionnaire) 
6) reside within 50 miles of Pittsburgh 
 
Exclusion Criteria: 
1) severe aphasia (Boston Diagnostic Aphasia Examination score ≤1) 
2) currently receiving outpatient or home care rehabilitation services (physical therapy, 
occupational therapy, or speech therapy) 
3) current active cancer treatment 
4) medical history of neurodegenerative disorder (i.e. dementia, Parkinson’s disease, multiple 
sclerosis, Lou Gehrig's disease (ALS), glioblastoma, myasthenia gravis) 
5) current major depressive disorder, psychiatric condition, substance abuse (assessed via in-
person participant interview after signed informed consent, using Patient Health Questionnaire-9, 
PRIME-MD/MINI) 
 
Statistical Considerations 
Primary Outcome Measures: 

Page 7 of 7 
 
1. Change in daily sedentary time accumulated in bouts greater than or equal to 30 minutes 
(Baseline to Week 11), ActivPAL 
2. Change in daily number of sedentary breaks (Baseline to Week 11), ActivPAL 
Secondary Outcome Measures: 
1. Change in daily number of sedentary breaks (Baseline to Week 18), ActivPAL 
2. Change in daily sedentary time accumulated in bouts greater than or equal to 30 minutes 
(Baseline to Week 18), ActivPAL 
3. Change in Participation (Baseline to Week 11), Stroke Impact Scale-Participation 
Subscale 
4. Change in Participation (Baseline to Week 18), Stroke Impact Scale-Participation 
Subscale 
 
PRELIMINARY DATA SCREENING: 
We will explore distributions of all descriptive and outcome variables to understand the variance 
and identify outliers in our data set. We will examine our data set to identify patterns of missing 
data and descriptive characteristics for whom data were missing.  
 
PRIMARY AND EXPLORATORY OUTCOMES  
This study employs a delayed baseline design to allow assessment of baseline stability. We will 
examine stability on primary and secondary outcomes between baseline 1 (week 1) and baseline 
2 (week 6). We will then compute a single mean baseline score for each participant using 
baseline 1 (week 1) and baseline 2 (week 6). 
 
We will then compute within-person change scores between baseline and post-intervention 
(week 11) and between baseline and follow-up (week 18). The group’s mean change score and 
standard deviation will be reported.  

 
                                                                          Page 1 of 9                                           
           
   University Of Pittsburgh          
     Institutional Review Board    
 
Approval Date:  8/29/2018 
 
 
IRB #:   PRO17070071 
 
 
School of Health and Rehabilitation Sciences 
Department of Occupational Therapy 
5012 Forbes Tower 
Pittsburgh, PA 15260 
Phone: 412-383-6620 
Fax: 412-383-6613 
 
 
 
CONSENT TO ACT AS A PARTICIPANT IN A RESEARCH STUDY 
 
TITLE: Activating Behavior for Lasting Engagement (ABLE) After Stroke 
 
PRINCIPAL INVESTIGATOR:  Emily Kringle, MOT, OTR/L 
Occupational Therapy 
University of Pittsburgh 
5055 Forbes Tower, Pittsburgh, PA 15260 
Telephone: (412) 383-4085 
CO-INVESTIGATORS: 
Elizabeth Skidmore, PhD, OTR/L 
Professor, Occupational Therapy 
University of Pittsburgh 
5012 Forbes Tower, Pittsburgh, PA 15260 
Telephone: (412) 383-6617 
 
Meryl Butters, PhD 
Associate Professor, Psychiatry 
University of Pittsburgh 
3811 O’Hara Street, Pittsburgh, PA 15213 
Telephone: (412) 586-9111 
Grace Campbell, PhD, MSW, RN, CRRN 
Assistant Professor, School of Nursing 
University of Pittsburgh 
336 Victoria Building, Pittsburgh, PA 15260 
Telephone: (412) 383-8754 
 
Bethany Barone Gibbs, PhD 
Assistant Professor, Health and Physical Activity 
University of Pittsburgh 
128 Oak Hill, Pittsburgh, PA 15260 
Telephone: (412) 383-4002 
Lauren Terhorst, PhD 
Associate Professor, Occupational Therapy 
University of Pittsburgh 
5034 Forbes Tower, Pittsburgh, PA 15260 
Telephone: (412) 383-1141 
 
Ellen Whyte, MD 
Assistant Professor, Psychiatry 
University of Pittsburgh 
3811 O’Hara Street, Pittsburgh, PA 15213 
Telephone: (412) 246-6260 
 
Michael McCue, PhD 
Professor, Rehabilitation Science and 
Technology 
University of Pittsburgh 
5042 Forbes Tower, Pittsburgh, PA 15260 
Telephone: 412-383-6589 
Research Staff Telephone: (412) 383-6752 
Kara Deliman, MS 
Rachelle Brick, MSOT, OTR/L 
Stephanie (Rouch) Harleman, MOT, OTR/L 
Ann Keller, BA 
Jessica Kersey, MOT, OTR/L 
Amit Sethi, PhD, OTR/L 
Kasey Stepansky, MS, OTR/L, C/NDT 
Laura Waterstram, MOT, OTR/L 
Michelle Zmuda, BS 

 
ABLE 
 
Page 2 of 9 
           
   University Of Pittsburgh          
     Institutional Review Board    
 
Approval Date: 8/29/2018 
 
IRB #:   PRO17070071 
 
 
SOURCE OF SUPPORT: No support 
 
Researchers at the University of Pittsburgh are conducting a research study to see whether a 
new rehabilitation intervention, the Activating Behavior for Lasting Engagement (ABLE) 
intervention can help people to be more active in their daily life after stroke.  You are being 
asked to take part in this research study because you have had a stroke at least 6 months ago 
and less than 5 years ago, and completed our initial screening questions over the telephone. 
We will ask 25 people to participate in this research study.    
Study Screening:  
If you decide to take part in this research study, we will conduct in-
person screening, where we will ask you some questions about 
your current mood, psychiatric history, and current substance 
abuse. These tests will tell us if you are eligible for this study, and 
together they will take about 45 minutes.  
Study Procedures:  
If you are eligible, we will ask you to complete baseline 
assessments in two parts. Part 1 will occur right away. During Part 
1, we will ask you to complete some tests of your thinking and 
moving abilities, your arm function, and answer questions about 
your fatigue, pain, life satisfaction, physical activity, and daily 
activities. These tests will take 4 hours total, and may be split into 
2 sessions. We may video record portions of this testing.  
We will also ask you to wear an ActivPAL monitor for 7 days. An 
ActivPAL is a small, flat monitor that measures the time you spend 
sitting, standing, and taking steps throughout the day. The ActivPAL 
will be waterproofed and fastened to the front of your thigh. You 
can wear the ActivPAL during all of your daily activities, including 
water activities. Before we apply the ActivPAL, we will check the 
sensation on the front of your thigh using a light touch screening 
test. During the time that you are wearing the ActivPAL, we will 
ask you to write down the time that you go to bed and the time 
that you wake up in the morning in a diary that we will provide.  
Part 2 will occur during week 5. During Part 2, we will ask you to 
wear an ActivPAL monitor for 7 days, using the same procedure as in Part 1. We will also ask 
you to answer questions about your daily activities and your mood. The questions in Part 2 
will take approximately 30 minutes.  
After the tests, a rehabilitation professional will meet with you in person for 12 intervention 
sessions in your home.  Each session will last for approximately 45 minutes. During these 
sessions, the rehabilitation professional will ask you about your daily routines. Your therapist 
will work with you using the ABLE intervention. The ABLE intervention is a rehabilitation 
Follow-Up 
Week 18 
Testing: 90 minutes 
ActivPAL: 7 days 
Post-Intervention 
Week 11 
Testing: 60 minutes 
ActivPAL: 7 days 
Intervention 
Weeks 7-10 
12 therapy sessions 
Baseline Part 2 
Week 6 
Testing: 30 minutes 
ActivPAL: 7 days 
Baseline Part 1 
Week 1 
Testing: 4 hours 
ActivPAL: 7 days 

 
ABLE 
 
Page 3 of 9 
           
   University Of Pittsburgh          
     Institutional Review Board    
 
Approval Date: 8/29/2018 
 
IRB #:   PRO17070071 
 
 
treatment that involves scheduling meaningful activities throughout your day and problem 
solving to identify practical strategies to reduce prolonged amounts of time spent sitting. These 
sessions may be videotaped.  
We will ask you to complete some questionnaires about your perspectives on the treatment 
during the intervention sessions. These questions will take approximately 30 minutes.  
At the end of your last intervention session, we will ask you wear the ActivPAL monitor for 7 
days and to answer questions about your daily activities and your mood.  This will take 
approximately 60 minutes. 
We will follow up with you 8 weeks later. At that time, we will ask you to wear the ActivPAL 
monitor for 7 days and to answer questions about your activities, pain, fatigue, outlook on life, 
and your mood. We will also share some of your ActivPAL data with you and ask you to discuss 
your activities during times of the week or day when you spent the most time sitting, standing, 
or stepping. In total, the follow-up activities will take approximately 90 minutes. 
If you were involved in the Adapting Daily Activity Performance Through Strategy Training 
(ADAPTS) research study through the Occupational Therapy Department at the University of 
Pittsburgh, we are asking your permission to collect your cognitive test results from that study 
to use in our analyses for this study. This will prevent you from needing to repeat several of the 
tests during baseline 1. 
As part of this study, we are requesting your authorization or permission to review your 
medical records. We will obtain past, current and future demographic (age, gender, race, 
ethnicity, education, vocation, pre-stroke residential status, social support), medical (stroke 
etiology and onset, co-morbidities, medications) and rehabilitation history (type and duration, 
documented impairments). We will also gather information about the size and location of your 
stroke from imaging results. This information will be used to help us learn about your stroke 
and rehabilitation. As part of this research study, some information that we obtain from you 
may be placed into your medical records. If we identify previously undiagnosed conditions that 
may benefit from treatment, we will notify you and request permission to notify your primary 
care physician. In this case, testing results may be placed into your medical record.  
Identifiable medical record information will be made available to members of the research 
team for an indefinite period of time. Your de-identified medical information, as well as 
information obtained during this research study, may be shared with other researchers in the 
future. We will protect your privacy and the confidentiality of your records, as described in 
this document, but cannot guarantee the confidentiality of your research records, including 
information obtained from your medical records, once your personal information is disclosed to 
others outside UPMC or the University. This authorization is valid for an indefinite period of 
time. However, you can always withdraw your authorization to allow the research team to 
review your medical records by contacting the investigators listed on the first page and making 
the request in writing. If you do so, you will no longer be permitted to participate in this study. 
Any information obtained from you up to that point will continue to be used by the research 

 
ABLE 
 
Page 4 of 9 
           
   University Of Pittsburgh          
     Institutional Review Board    
 
Approval Date: 8/29/2018 
 
IRB #:   PRO17070071 
 
 
team. The possible risks and discomforts of this research study include the possibility that you 
may become frustrated, upset, tired during the testing and the treatment sessions. If this 
happens, you will be allowed to take a break or stop the testing. There is also the risk that 
information about you may be seen by someone who is not part of the research team. We will 
make every effort to ensure that your information is protected, so that only authorized persons 
can see your information. There is a possibility that you may experience a fall or injury during 
the testing and the treatment sessions. A trained rehabilitation professional will be present 
during the testing and the treatment sessions. If you do experience a fall or injury, you will 
receive treatment through UPMC. Finally, there is a possibility that you may experience skin 
irritation from adhesive used to fasten the ActivPAL monitor to your leg. If skin irritation occurs, 
you will be able to remove the ActivPAL monitor and we will work with you to identify 
alternative strategies for fastening the ActivPAL to your leg.  
If you believe that the research procedures have resulted in an injury to you, immediately 
contact the Principal Investigator who is listed on the first page of this form. Emergency medical 
treatment for injuries solely and directly related to your participation in this research study will 
be provided to you by the hospitals of UPMC. Your insurance provider may be billed for the 
costs of this emergency treatment, but none of those costs will be charged directly to you. If 
your research-related injury requires medical care beyond this emergency treatment, you will 
be responsible for the costs of this follow-up care. At this time, there is no plan for any 
additional financial compensation. 
You may benefit by participating in the treatment sessions with the rehabilitation professional 
but there is no guarantee that this will help you. We hope to learn whether this intervention is 
effective to help people return to an active lifestyle after a stroke. 
If we learn about any new risks that may cause you to change your mind about continuing to 
participate, we will let you know.  
Neither you, nor your insurance provider, will be charged for any of the procedures performed 
for the purpose of this research study. You will be charged, in the standard manner, for any 
procedures performed for your routine medical and rehabilitation care (i.e., doctor or medical 
visits, treatments, and all other tests and procedures including laboratory tests and imaging 
that you would normally have as part of your regular medical care). 
You will be paid $25 for each completed assessment time-point (Baseline part 1, Baseline part 
2, Post-intervention, 8-week follow-up). We will ask some participants to complete only 
Baseline part 1, Post-intervention, and 8-week follow-up. Thus, you may be paid $75 or $100 
for participating in this study. If you do not complete the full study, you will be paid $25 for 
each completed assessment time point. 
Any information about you obtained from this research will be kept as confidential (private) 
as possible. Research records, including the video, will be stored in a locked file cabinet or in 
password-protected computer databases, and you will not be identified by name in any 
publication of the research results unless you sign a separate consent form giving your 

 
ABLE 
 
Page 5 of 9 
           
   University Of Pittsburgh          
     Institutional Review Board    
 
Approval Date: 8/29/2018 
 
IRB #:   PRO17070071 
 
 
permission (release). Our assessment processes include screening for depression, psychiatric 
conditions. If we identify that you have any of these conditions or that you are at risk for 
suicide, we will notify you and your primary caregiver. In addition, we may be required to notify 
your primary care physician. We will also provide you with information regarding resources 
available to access treatment for these conditions (e.g., crisis network contact information). 
In addition to the investigators listed on the first page of this consent form and their research 
staff, authorized representatives of the University of Pittsburgh Research Conduct and 
Compliance Office may review your identifiable research information for the purpose of 
monitoring the appropriate conduct of this research study. 
In unusual cases, the investigators may be required to release identifiable information related 
to your participation in this research study in response to an order from a court of law. If the 
investigators learn that you or someone with whom you are involved is in serious danger or 
potential harm, they will need to inform, as required by Pennsylvania law, the appropriate 
agencies. 
The investigators may continue to use and disclose, for the purposes described above, 
identifiable information (which may include your identifiable medical information) related to 
your participation in this research study for a minimum of seven years and for as long as it may 
take to complete this research study.  
Your participation in this research study is completely voluntary. Whether or not you provide 
your consent for participation in this research study, or if you decide to withdraw your consent 
after you sign this consent form, will have no effect on your current or future relationship with 
the University of Pittsburgh, UPMC hospital or affiliated health care provider. You may discuss 
your care with another doctor who is not associated with this research study. You are not under 
any obligation to participate in any research study offered by your doctor. If you decide not to 
take part in this research study, you will receive usual rehabilitation care as determined by 
your clinical team. 
You may withdraw your consent for participation in this research study at any time. Any 
identifiable research or medical information obtained for this research study prior to the time 
you formally withdraw your consent may continue to be used and disclosed by investigators for 
the purposes described above. To formally withdraw your consent for participation in this 
research study, provide a written and dated notice of this decision to the Principal Investigator 
of this research study at the address listed on the first page of this form or call the number 
listed.  
Your decision to withdraw your consent for participation in this research study will have no 
effect on your current or future relationship with the University of Pittsburgh. Your decision to 
withdraw your consent for participation in this research study will have no effect on your 
current or future medical care at a UPMC hospital or affiliated health care provider or your 
current or future relationship with a health care insurance provider.  

 
ABLE 
 
Page 6 of 9 
           
   University Of Pittsburgh          
     Institutional Review Board    
 
Approval Date: 8/29/2018 
 
IRB #:   PRO17070071 
 
 
It is important that you understand that participation in the study is above and beyond your 
usual rehabilitation care. If you chose not to participate in the study, or chose to withdraw 
from the study at a later date, you will still receive rehabilitation care. 
You may be removed from the study if it is determined by the research team for any reason 
that you do not meet criteria for the study or if the investigator believes that further 
participation in the study would place you at risk for injury (e.g. not following study procedures 
or demonstrating poor safety judgment).  
One of your health care providers may be involved as an investigator in this research study. As 
both your provider and a research investigator, s/he is interested both in your medical care and 
the conduct of this research study. Before agreeing to participate in this research study, or at 
any time during your study participation, you may discuss your care with another provide who 
is not associated with this research study. You are not under any obligation to participate in any 
research study offered by a member of your health care team. 

 
ABLE 
 
Page 7 of 9 
           
   University Of Pittsburgh          
     Institutional Review Board    
 
Approval Date: 8/29/2018 
 
IRB #:   PRO17070071 
 
 
VOLUNTARY CONSENT 
The above information has been explained to me and all of my current questions have been 
answered. I understand that I am encouraged to ask questions about any aspect of this 
research study during the course of this study, and that such future questions will be answered 
by a qualified individual or by the investigator(s) listed on the first page of this consent 
document at the telephone number(s) given. I understand that I may always request that my 
questions, concerns or complaints be addressed by a listed investigator.  
 
I understand that I may contact the Human Subjects Protection Advocate of the IRB Office, 
University of Pittsburgh (1-866-212-2668) to discuss problems, concerns, and questions; obtain 
information; offer input; or discuss situations that have occurred during my participation.  
 
By signing this form I consent to participate in this research study and provide my authorization 
to share my medical records with the research team.  
________________________________ 
 
 
__________________ 
Participant’s Signature 
 
 
 
 
Date 
 
CERTIFICATION of INFORMED CONSENT 
I certify that I have explained the nature and purpose of this research study to the above-
named individual(s), and I have discussed the potential benefits and possible risks of study 
participation. Any questions the individual(s) have about this study have been answered, and 
we will always be available to address future questions as they arise. I further certify that no 
research component of this protocol was begun until after this consent form was signed. 
___________________________________  
 
________________________ 
Printed Name of Person Obtaining Consent  
 
Role in Research Study 
_________________________________ 
 
 
____________ 
Signature of Person Obtaining Consent 
 
 
Date 
 

 
ABLE 
 
Page 8 of 9 
           
   University Of Pittsburgh          
     Institutional Review Board    
 
Approval Date: 8/29/2018 
 
IRB #:   PRO17070071 
 
 
PROXY CONSENT 
________________________________ 
 
 
__________________ 
Participant’s Name (Print) 
 
 
 
 
Date 
 
The above-named individual is unable to provide direct consent for study participation because 
 
______________________________________________________________________________ 
 
By signing this form I give my consent for him/her to participate in this research study and 
provide my authorization to share his/her medical records with the research team. 
 
________________________________ 
 
___________________________________ 
Representative’s Name (Print) 
 
 
Representative’s Relationship to Participant 
 
________________________________ 
 
 
__________________ 
Representative’s Signature 
 
 
 
 
Date 
 
________________________________ 
 
 
__________________ 
Witness Signature  
 
 
 
 
 
Date 
 
 
VOLUNTARY ASSENT: 
This research has been explained to me, and I agree to participate and to share my medical 
records with the research team.  
________________________________ 
 
 
__________________ 
Participant’s Signature  
 
 
 
 
Date 
 
VERIFICATION OF EXPLANATION: 
I certify that I have carefully explained the purpose and nature of this research study to the 
participant in appropriate language. He/she has had an opportunity to discuss it with me in 
detail. I have answered all his/her questions and he/she has provided affirmative agreement 
(i.e., assent) to participate in this study.  
________________________________ 
 
 
____________________ 
Investigator’s Signature 
 
 
 
 
Role in Research Study 
________________________________ 
 
 
__________________ 
Investigator’s Printed Name  
 
 
 
Date 

 
ABLE 
 
Page 9 of 9 
           
   University Of Pittsburgh          
     Institutional Review Board    
 
Approval Date: 8/29/2018 
 
IRB #:   PRO17070071 
 
 
CONSENT FOR CONTINUED PARTICIPATION 
I understand that I am currently participating in a research study. I further understand that 
consent for my participation in this research study was initially obtained from my authorized 
representative because of my inability to provide direct consent at the time that this initial 
consent was requested. I have now recovered to the point where it is felt that I am able to 
provide direct consent for continued participation in this research study.  
 
The above information has been explained to me and all of my current questions have been 
answered. I understand that I am encouraged to ask questions, voice concerns or complaints 
about any aspect of this research study during the course of this study, and that such future 
questions, concerns or complaints will be answered by a qualified individual or by the 
investigator(s) listed on the first page of this consent document at the telephone number(s) 
given. I understand that I may always request that my questions, concerns or complaints be 
addressed by a listed investigator. I understand that I may contact the Human Subjects 
Protection Advocate of the IRB Office, University of Pittsburgh (1-866-212-2668) to discuss 
problems, concerns, and questions; obtain information; offer input; or discuss situations in the 
event that the research team is unavailable. By signing this form I agree to participate in this 
research study. 
 
By signing this form I agree to continue to participate in this research study and provide my 
authorization to share my medical records with the research team. 
 
________________________________ 
 
 
___________________ 
Participant’s Signature 
 
 
 
 
Date 
 
CERTIFICATION of INFORMED CONSENT 
I certify that I have explained the nature and purpose of this research study to the above-
named individual(s), and I have discussed the potential benefits and possible risks of study 
participation. Any questions the individual(s) have about this study have been answered, and 
we will always be available to address future questions as they arise. I further certify that no 
research component of this protocol was begun until after this consent form was signed. 
 
___________________________________  
 
________________________ 
Printed Name of Person Obtaining Consent  
 
Role in Research Study 
 
_________________________________ 
 
 
____________ 
Signature of Person Obtaining Consent 
 
 
Date