Effects of Improvisational Dance on Cognition and Daily Function Among People With Parkinson Disease
Phase: NA
Conditions: Parkinson Disease
Sponsor: Washington University School of Medicine

 
 
 
 
 
 
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1 
 
 
 
Effects of Improvisational Dance on Cognition and Daily Function 
Among People With Parkinson's Disease 
 
Principal Investigator:   
Erin R. Foster 
Maggie Fleita 
 
 
 
 
 
 
Revised 9/24/2019 
 
 

 
 
 
 
 
 
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2 
TABLE OF CONTENTS 
A 
INTRODUCTION ............................................................................................................................... 4 
A1 
STUDY ABSTRACT ......................................................................................................................... 4 
A2 
PRIMARY HYPOTHESIS ................................................................................................................... 4 
A3 
PURPOSE OF THE STUDY PROTOCOL .............................................................................................. 4 
B 
BACKGROUND .................................................................................................................................. 4 
B1 
PRIOR LITERATURE AND STUDIES .................................................................................................. 4 
B2 
RATIONALE FOR THIS STUDY ......................................................................................................... 5 
C 
STUDY OBJECTIVES........................................................................................................................ 6 
C1 
PRIMARY AIM ................................................................................................................................ 6 
C2 
SECONDARY AIM ........................................................................................................................... 7 
C3 
RATIONALE FOR THE SELECTION OF OUTCOME MEASURES ........................................................... 7 
D 
INVESTIGATIONAL AGENT .......................................................................................................... 7 
E 
STUDY DESIGN ................................................................................................................................. 7 
E1 
OVERVIEW OR DESIGN SUMMARY ................................................................................................. 8 
E2 
SUBJECT SELECTION AND WITHDRAWAL....................................................................................... 8 
2.a 
Inclusion Criteria ..................................................................................................................... 8 
2.a 
Exclusion Criteria ..................................................................................................................... 8 
2.b 
Ethical Considerations ............................................................................................................. 8 
2.c 
Subject Recruitment Plans and Consent Process ..................................................................... 8 
2.d 
Randomization Method and Blinding ....................................................................................... 9 
2.e 
Risks and Benefits ..................................................................................................................... 9 
2.f 
When and How to Withdraw Subjects ........................................................................................... 9 
2.g 
Data Collection and Follow-up for Withdrawn Subjects .......................................................... 9 
E3 
STUDY DRUG ................................................................................................................................. 9 
F 
STUDY PROCEDURES ....................................................................................................................10 
F1 
SCREENING FOR ELIGIBILITY.............................................................................................................10 
F2 
SCHEDULE OF MEASUREMENTS ........................................................................................................10 
F3 
CLASS STRUCTURE............................................................................................................................10 
F4 
SAFETY AND ADVERSE EVENTS ........................................................................................................11 
4.a 
Safety and Compliance Monitoring .........................................................................................11 
4.b 
Medical Monitoring .................................................................................................................11 
4.c 
Definitions of Adverse Events ..................................................................................................11 
4.d 
Classification of Events ...........................................................................................................11 
4.e 
Data Collection Procedures for Adverse Events .....................................................................11 
4.f 
Reporting Procedures ..................................................................................................................11 
4.g 
Adverse Event Reporting Period ..............................................................................................11 
4.h 
Post-study Adverse Event ........................................................................................................11 
G 
STATISTICAL PLAN ........................................................................................................................11 
G1 
SAMPLE SIZE DETERMINATION AND POWER .................................................................................12 
G2 
INTERIM MONITORING AND EARLY STOPPING ..............................................................................12 
G3 
ANALYSIS PLAN............................................................................................................................12 
G4 
STATISTICAL METHODS ................................................................................................................12 
G5 
MISSING OUTCOME DATA ............................................................................................................12 
G6 
UNBLINDING PROCEDURES ...........................................................................................................12 
H 
DATA HANDLING AND RECORD KEEPING .............................................................................12 
H1 
CONFIDENTIALITY AND SECURITY ................................................................................................12 

 
 
 
 
 
 
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3 
H2 
TRAINING......................................................................................................................................13 
H3 
CASE REPORT FORMS AND SOURCE DOCUMENTS .........................................................................13 
H4 
RECORDS RETENTION ...................................................................................................................13 
H5 
PERFORMANCE MONITORING .......................................................................................................13 
I 
STUDY MONITORING, AUDITING, AND INSPECTING ..........................................................13 
J 
STUDY ADMINISTRATION ...........................................................................................................13 
J1 
ORGANIZATION AND PARTICIPATING CENTERS .................................................................................13 
J2 
FUNDING SOURCE AND CONFLICTS OF INTEREST ..............................................................................14 
J3 
COMMITTEES .....................................................................................................................................14 
J4 
SUBJECT STIPENDS OR PAYMENTS ....................................................................................................14 
J5 
STUDY TIMETABLE ...........................................................................................................................14 
K 
PUBLICATION PLAN ......................................................................................................................14 
L 
ATTACHMENTS ...............................................................................................................................14 
L1 
TABLES .........................................................................................................................................14 
L2 
APPENDICES..................................................................................................................................15 
L3 
INFORMED CONSENT DOCUMENTS.................................................................................................21 
L4 
QUESTIONNAIRES AND WRITTEN ASSESSMENTS ..........................................................................27 
M 
REFERENCES ...................................................................................................................................35 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
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4 
A Introduction 
A1 Study Abstract 
 
Parkinson’s disease is a neurodegenerative disease that results in various deficits, 
including cognitive impairments, for which there is a lack of interventions. Improvisational 
dance (ID) is spontaneously generated movement, similar to how one moves in 
everyday life.  ID requires the integration of cognitive capacities to execute movements, 
and thus may strengthen cognitive processes involved in daily life function. ID has been 
shown to improve motor function in people with PD. The purpose of this study is to 
understand the effects of ID on cognition and daily function for people with PD. 
Specifically, it will test the effect of IMPROVment®, a method of ID designed for people 
with PD, on cognition and daily function. We will conduct a quasi-randomized wait-list 
controlled trial. Participants will be recruited and screened for eligibility through the St. 
Louis Chapter American Parkinson's Disease Association. Inclusion criteria includes: 50 
years or older, PD diagnosis (mild to moderate), follows simple verbal cues, walks at 
least 3 meters independently , no contraindications in physical activity, mild cognitive 
impairment (determined by MOCA score), and no diagnosis of other severe 
comorbidities. The target sample size is 15-20 participants. Once enrolled, participants 
will undergo baseline testing (T1). Then participants will be randomly assigned to one of 
two groups: ID or waitlist control (WC). Participants in the ID group will begin a 12-week 
intervention where the group will meet once a week for a 1-hour IMPROVment® class. 
Participants in the WC group will continue with their regular routine for 12 weeks. After 
12 weeks, all participants will complete Time 2 testing (T2; primary endpoint). Then WC 
participants will participate in the same IMPROVment® class for the following 12 weeks 
followed by Time 3 testing (T3; exploratory endpoint). For primary analysis, assessment 
scores will be compared across time point (T1, T2) and group (ID, WC) using mixed 
model ANOVA. Our results will provide further information on the effects of the 
IMPROVment® method for people with PD. 
A2 Primary Hypothesis 
The central hypothesis is that engagement in an improvisational dance (ID) class will 
benefit cognition and daily function among people with PD. 
A3 Purpose of the Study Protocol 
The purpose of this study protocol is to detail the various aspects of this study. 
 
B Background 
B1 Prior Literature and Studies 
IMPROVment® was initially created for people with PD and has been used in several 
research studies since its conception4, 7, 14.  This method was developed by Christina 
Tsoules Soriano, a dance researcher, and is a standardized intervention used with a 
wide range of older adults.  The proposed study will follow the protocol developed by its 
creators. IMPROVment® has been shown to have positive impacts on motor function in 
people with PD, but cognition and daily function have not yet been assessed. Because 

 
 
 
 
 
 
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5 
IMPROVment® was developed specifically for people with PD and is centered around 
community engagement, physical and mental fitness, and freedom to create movement, 
it has high potential to improve the performance and participation of people with PD. 
Further, because it challenges cogntion in ways that resemble the cognitive challenges 
of daily life, we hypothesize that it will be particularly beneficial for cognitive aspects of 
daily function. Furthering the evidence base for this method and demonstrating if it can 
be implemented by outside groups will increase its availability to the population of people 
with PD at large. 
B2 Rationale for this Study 
People with Parkinson’s disease (PD) experience cognitive deficits. 
Up to 50% of the 10 million people with PD experience cognitive deficits, 
specifically in visuospatial function, memory, and executive function1, 8-11. Visuospatial 
function is the ability to identify and integrate the context of the surrounding visual space. 
People with PD experience increased difficulty in mobility due to decreased depth 
perception, inhibiting them from completing everyday activities safely and effectively8. 
Along with visuospatial deficits, people with PD experience memory issues, such as 
deficits in working memory, long-term memory, and procedural memory, which can 
inhibit them from completing familiar tasks, and learning new tasks8. The area in which 
cognitive deficits are often most prevalent in people with PD is executive function. 
Executive function consists of higher-order cognitive processes including, decision 
making, inhibition of unnecessary behaviors, and self-monitoring. Specifically, people 
with PD experience issues in multitasking, planning and organizing, and problem 
solving8, 11.  
 
PD-related cognitive deficits negatively impact daily function. 
The progression of PD and associated level of impairment is highly 
individualized. People with PD experience impairments in areas of motor, affect, and 
cognition, all of which impact one’s daily function. Daily function includes one’s 
performance of daily activities as well as their general involvement in daily activities and 
life situations (termed participation). Since PD is categorized as a movement disorder, 
research and clinical care often emphasize its motor deficits.  Recent literature, however, 
suggests that cognitive deficits, and specifically executive dysfunction, present the most 
problems in everyday life for people with PD2, 12. Executive function largely contributes to 
how one carries out his/her daily functions. Dysfunction in this area of cognition can be 
detrimental to an individual with PD’s engagement in everyday life.  Research shows 
that executive dysfunction contributes to reduced social engagement, leisure 
participation, and issues with instrumental activities of daily living (iADL’s), such as 
medication management and meal preparation2, 3, 12. Due to its negative effects on daily 
function, effective interventions to address cognition in PD are imperative. 
 
Dance is an emerging intervention for people with PD. 
Dance is emerging as a potential therapy for people with PD. Dance is thought to 
be particularly effective because of “its entertaining nature and facilitation of participants’ 
involvement”16. This notion is supported by evidence showing that participants have 
more consistent attendance and motivation for dance compared to more traditional 
exercise programs17. Evidence supports the use of several styles of dance as therapy, 
including, but not limited to, tango, ballet, and modern5, 6, 13, 16, 17. The various styles of 
dance emphasize different types of movement tempos, dynamics, and postures, as well 
as cognitive processes. In this way, dance may address a wide range of daily functions 

 
 
 
 
 
 
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6 
since activity performance and participation require a variety of movements and 
cognitive processes.  
In line with the traditional focus on motor function in PD, much of the literature 
and evidence on dance as an intervention for PD emphasize physical deficits5. For 
example, dance has been associated with significant improvements in gait and balance 
for people with PD5, 13. However, dance is not only a motor task but also requires the 
integration of cognitive processes to learn, plan, and execute movements. Cognition has 
been included as a secondary outcome in several studies of dance, and improvements 
in processing speeds in motor planning and judgement and cognitive task switching 
have been observed5, 13. Researchers in the field have called for studies to focus 
explicitly on the cognitive effects of dance for people with PD because of the growing 
amount of evidence suggesting non-motor improvements with dance6, 14, 15.  
 
Improvisational Dance (ID) may be particularly effective for addressing cognition and 
daily function in people with PD. 
People live their lives based on unplanned, natural movement. For people with 
PD, this lack of structure can present problems with everyday activities, such as 
functional mobility and iADL tasks. ID is spontaneous movement that is thought of and 
executed on the spot. Movement in ID challenges motor planning, decision making, and 
flexible thinking that “builds on the idea that daily living requires flexible, adaptive 
responses to real-life challenges”14. This direct application of ID to real life may render ID 
a particularly beneficial form of dance for people with PD. This idea is supported by Joan 
Toglia’s Dynamic Interactional Model, which looks at cognition in terms of the interaction 
between the person, activity, and the environment20. In practice, this frame of reference 
is used to build cognitive strategies that apply to varying situations. In ID classes, 
participants may benefit from the strategies given in class and apply them to real-life 
situations. Further, the free movement of ID requires the participant to use higher order 
cognitive processes and by challenging these processes, we may strengthen them. 
Another benefit to ID classes is that there is no right or wrong, and no set 
movements. These features allow free expression through movement and broad 
accessibility to the population of people with PD in which there is a wide range of 
functional capacity. Participants involved in more structured dance classes have 
reported feeling overwhelmed by the strict nature of the class, so they may prefer the 
self-determination of ID14.  
 
Community-based programs promote activity engagement among people with PD. 
Aside from dance itself, ID classes provide a fun, social form of activity 
engagement for participants. Research shows that people with PD that engage in PD-
specific community-based programs are more likely to participate in everyday activities 
and roles21, 22. Not only does participation in community-based programs increase 
activity participation, research suggests that community engagement increases 
participation in activities that people with PD ceased at the onset of their diagnosis22. 
 
C Study Objectives 
C1 Primary Aim 
Investigate the effects of IMPROVment® on cognition for people with PD.  
To test this aim, participants’ cognition will be assessed using the NIH Toolbox Cognitive 
Battery (NIH (CB)), the Alternate Uses Task (AUT), and the Weekly Calendar Planning 

 
 
 
 
 
 
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7 
Activity (WCPA). Cognitive test scores will be compared across time points (T1, T2) and 
between groups (ID, WC) using a mixed model repeated measures ANOVA. We 
hypothesize that IMPROVment® will have positive effects on the cognitive abilities of 
people with PD. 
C2 Secondary Aim 
Investigate the effects of IMPROVment® on daily functions for people with PD. 
Participants will also complete two questionnaires to assess daily function: Older 
Americans Resources and Services Scale- Extended Version (OARS-Ex) and PROMIS 
Satisfaction with Participation in Discretionary Social Activites (SPDSA). These scores 
will be compared similar to the above aim. We hypothesize that IMPROVment® will have 
positive effects on daily function in people with PD.  
C3 Rationale for the Selection of Outcome Measures 
The following table details the outcome measures involved in this study.  Members of the 
research team have been trained in the following measures. 
Assessment Description  
NIH (CB) A comprehensive, performance-based test comprised of motor, emotion, 
sensation, and cognition assessments. For the purpose of this study, we 
will be using the cognitive battery to assess processes involved in 
learning and comprehension (i.e. thinking, remembering, problem-solving, 
judging). The battery consists of tasks involving the use of executive 
function, memory, attention, and language. 
AUT A verbal test of divergent thinking where the participant is given the name 
of an object and must name as many uses of that object as possible in a 
3-minute time period. This assessment measures verbal fluency, 
originality, flexibility, and elaboration.  
WCPA A performance-based measure that assesses an individual’s level of 
executive function. The task involves entering a list of errands into a 
calendar while following rules, keeping track of time, and managing 
conflicts.  
OARS-Ex A self-report questionnaire-based assessment that assesses perceived 
performance in ADL and iADL tasks by reporting the level of difficulty that 
they experience while completing the specific activity. Areas assessed 
include ADL tasks (walking, eating, dressing, grooming, getting in and out 
of bed, bathing, and toileting) and IADL tasks (using a telephone, 
traveling, shopping, preparing meals, housework, managing medication, 
and handling money)18. 
SPDSA A self-report questionnaire that assesses satisfaction with leisure 
activities and relationships with friends. 
 
D Investigational Agent  
NA 
E Study Design  
 

 
 
 
 
 
 
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8 
E1 Overview or Design Summary 
This is quasi-randomized wait-list controlled trial. Once enrolled, participants will 
undergo T1 assessments consisting of the primary outcome measures for each aim 
(described above and attached) and other relevant factors (e.g. demographics, clinical 
characteristics, motor function). Participants will be randomly assigned (coin flip) to one 
of two groups: ID or WC group. Although our aim is to randomize participants to the 
different groups, if someone has a strong preference or inability to participate in one 
group or the other due to scheduling issues, we will try to accommodate his/her 
preferences. Each group will have 7-10 participants, a typical size for ID classes. This 
ensures enough participants to create a cohesive group, but also to provide an 
appropriate level of safety. The ID group will participate in a 12-week intervention where 
the group will meet once a week for a 1-hour IMPROVment® class. Participants in the 
WC group will continue with their regular routine for 12 weeks. After 12 weeks, all 
participants will complete T2 testing. Then WC participants will participate in the same 
IMPROVment® method for the following 12 weeks followed by T3 testing.  
 
E2 Subject Selection and Withdrawal  
 
2.a 
Inclusion Criteria  
Inclusion criteria for this study include over 50 years old, PD diagnosis with Hoehn and 
Yahr stage 1-3 (mild to moderate), independently walks at least 3 meters and ability to 
comprehend and follow simple verbal cues. 
2.a 
Exclusion Criteria  
Exclusion criteria of this study include, a Montreal Cognitive Assessment score less than 
or equal to 21 (indicating cognitive impairment that may interfere with class 
participation), diagnosis of other severe comorbidities, and contraindications to physical 
activity. In addition, participants must attend at least ten of the twelve classes for their 
data to be included in analysis (they will still be allowed to participate in the classes). 
2.b 
Ethical Considerations  
Participants will be given the choice to be involved in the study and may withdraw at any 
time without penalty.  
2.c 
Subject Recruitment Plans and Consent Process 
Participants will be recruited and screened for eligibility through the St. Louis Chapter 
American Parkinson’s Disease Assocation (APDA). Approximately 15-20 participants 
diagnosed with PD will be recruited for this study. Consent will be obtained from each 
participant by select members of the research team.  Each participant will be walked 
through the informed consent document in detail and allowed to ask questions with no 
cohersion.  Participants will be re-assented to additional research processes after 
9.24.2019 upon IRB reapproval. 
 

 
 
 
 
 
 
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9 
2.d 
Randomization Method and Blinding 
After consent is given and T1 testing is completed, participants will be randomly 
assigned (coin flip) to either participate immediately (i.e., starting the next week) in 12-
weeks of IMPROVment (ID group) or to continue with regular routine for 12 weeks 
before starting IMPROVment (WC group). Once we reach 10 participants in a group, 
remaining participants will be assigned to the other group. In addition, if the participant 
would like to be a part of this study, but can only participate in one group or the other, we 
will try to accommodate his/her needs. 
2.e 
Risks and Benefits 
Risks: 
Participantion in this study could result in the following risks.  In addition to these, there 
may be other unknown risks, or risks that we did not anticipate, associated with being in 
this study. 
One risk of participating in this study is that confidential information about participants 
may be accidentally disclosed. We will use our best efforts to keep the information about 
participants secure.  
Another risk of participating in this study is an increased risk for falls. Although we do not 
expect the participants to fall during the intervention, precautionary measures are in 
place to decrease this risk (i.e. certified therapist present at all times, OT students 
monitoring the participants, movement modifications sitting in a chair). 
 
Benefits: 
Participants will not directly benefit from being in this study.  Participants may indirectly 
benefit from participating in this study with the increased social participation and 
entertaining nature of the study program. 
However, we hope that, in the future, other people might benefit from this study because 
it will help to provide information on how people with PD can best learn and remember in 
their daily lives. 
2.f 
When and How to Withdraw Subjects  
Participants may withdraw from this study at any time. To withdraw, participants will tell a 
member of the study team that he/she is no longer interested in participating in the 
study. He/she may withdraw completely from the dance classes or continue to dance 
and just withdraw from testing. 
 
2.g 
Data Collection and Follow-up for Withdrawn Subjects  
Data already collected on participants who withdraw from the study will be securely 
stored in a RedCap database. With the participants’ consent, they may be used for 
comparison to those who remain in the study or for description of those who withdraw.  If 
a participant would like to withdraw their data, they will be equipped with the procedure 
to follow on the Human Research Protocol Office website. 
 
E3 Study Drug  
 
NA 

 
 
 
 
 
 
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10
F Study Procedures  
 
F1 Screening for Eligibility 
Participants will be screened for eligibility using the “Inclusion/Exclusion Criteria Referral 
Form: IMPROVment® Class Participation” (Appendix 1) 
F2 Schedule of Measurements 
T1 testing will include the collection of demographics information, National Institute of 
Health Toolbox Cognitive Battery, the Weekly Calendar Planning Activity, Alternate Uses 
Task, and the Unified Parkinson's Disease Rating Scale Section 3 Motor exam.  
Participants will also be asked to complete the Older Americans Resources and 
Services scale, Satisfaction with Participation in Discretionary Social Activities scale, the 
Parkinson Anxiety Scale, the Sleep Disturbance Scale, the Parkinson’s Disease Fatigue 
Scale and the Depression Scale questionnaires. These questionnaires can be 
completed prior to the first day of intervention via RedCap survey mode or on paper if 
preferred.  In addition, participants will be asked to complete a brief mood questionnaire 
at the beginning and end of each class.  The participant will mark how they are feeling 
on 4 scales (see Appendix 4).  
After the first 12 week period of intervention, both groups will be invited back to complete 
those same assessments (T2). After the second 12 week period, only the WC group will 
T3 testing with the same assessments.  
 
F3 Class Structure  
Classes will take place at the APDA in their group fitness room. Participants will use 
chairs and music during the class. Class will be instructed by an occupational therapy 
(OT) student that has trained as a dancer for 20 years and is certified to administer the 
IMPROVment® method after attending an in-person training by its original creators and 
continues to receive feedback to better the administration of IMPROVment®7. Class will 
begin and end with participants sitting in a circle formation to eliminate any feelings of 
hierarchy among the participants by creating a unified group. The classes consist of 
three parts: seated exercise, standing barre work, and across the floor movement (refer 
to Table 1). Movement cues are given by the instructor to the participants and progress 
through the themes of isolation, shape, time, flow, space/direction, and effort (refer to 
Table 2). Classes will be structured by using a set class protocol created by the 
IMPROVment team to ensure consistency in the method delivery.  Music that is popular 
with the age demographic will be played throughout the entire class. Trained OT 
students in the Cognitive and Occupational Performance Lab (PI: Erin R. Foster) and the 
APDA’s certified physical therapist (Tricia Creel, DPT) will attend all classes to ensure 
participant safety.  
 
Please see Appendix 2 for a detailed list of exercises that comprise class structure.  
 

 
 
 
 
 
 
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11
F4 Safety and Adverse Events  
4.a 
Safety and Compliance Monitoring 
Trained occupational therapy graduate students in the Cognitive and Occupational 
Performance Laboratory (PI: Erin R. Foster) and the APDA’s certified physical therapist 
(Tricia Creel, DPT) will attend all classes to ensure participant safety. We do not 
anticipate any serious adverse events; however, class participation may increase the 
risk for falls and minor resulting injuries (e.g., bruises, scrapes). We expect this 
occurrence to be low if at all present, as the participants have relatively low fall risk and 
precautionary measures are in place to prevent falls (i.e. certified PT and OT students 
present at all times to monitoring participants’ safety, safety modifications [e.g. sitting in 
a chair]). 
4.b 
Medical Monitoring  
 
NA 
4.c 
Definitions of Adverse Events 
NA 
4.d 
Classification of Events 
NA 
4.e 
Data Collection Procedures for Adverse Events 
See Adverse Event Reporting Form in Appendix 3. Data on the number and type of 
adverse events will be collected and reported when study results are disseminated. 
4.f 
Reporting Procedures 
See Adverse Event Reporting Form in Appendix 3. 
4.g 
Adverse Event Reporting Period 
Adverse events will be reported to the PI immediately (within one day), and the 
participant will be encouraged to report them to his/her primary care physician or 
neurologist within the week. 
4.h 
Post-study Adverse Event 
NA 
 
 
G Statistical Plan  
 

 
 
 
 
 
 
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12
G1  Sample Size Determination and Power 
Each group will have 7-10 participants, a typical size for ID classes. This ensures 
enough participants to create a cohesive group, but also to provide an appropriate level 
of safety. Since this is a pilot study, power analyses were not conducted. Rather, data 
from this study can be used to power future studies. Although attrition is not anticipated, 
we aim to recruit 10 participants per group to ensure there are at least 7 participants in 
the class.  
G2  Interim Monitoring and Early Stopping 
NA 
G3  Analysis Plan 
Aim 1: Investigate the effects of IMPROVment® on cognition for people with PD.  
Cognition will be assessed at pre (T1) and post (T2) using the NIH (CB), AUT, and 
WCPA. Scores obtained in these assessments will be compared across time point and 
group using mixed model ANOVA. 
 
Aim 2: Investigate the effects of IMPROVment® on daily functions for people with PD. 
Daily function will be measured at pre (T1) and posttest (T2) using the OARS-EX and 
SPDSA. Scores will be compared across time point and group using mixed model 
ANOVA. 
 
G4  Statistical Methods  
See above. Analysis will be conducted with IBM SPSS software. 
G5  Missing Outcome Data 
Participants with missing data will be excluded from analyses involving those data. Since 
this is a small  pilot study, we intend to maximixe the use of data we can collect. 
G6  Unblinding Procedures  
NA (this is not a blinded study) 
 
H Data Handling and Record Keeping  
 
H1 Confidentiality and Security 
Confidentiality will be maintained in accordance with applicable state and federal laws. 
Subject data will be coded numerically to protect individual identity. No identifiers will be 
used in presentation or publications. All data will be stored in locked cabinets or on 
computers within a private, secure network protected by a PIX firewall with remote 
access only permitted through virtual private network connections, as per HIPAA 
guidelines. Patients will be informed of all risks prior to participation. Subjects will be told 
that they may discontinue participation at any time, that they have the alternative not to 
participate in the study, and that this will not impact their medical care. All key personnel 
involved in the design or conduct of research involving the human subjects will receive 

 
 
 
 
 
 
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13
the required education on the protection of human research participants and HIPAA 
guidelines prior to funding of this project. Consent will be obtained in a private setting in 
the room where the experiment will take place.  Data will be stored in REDCap on the 
secure WUSM server. 
 
A photographer will attend class to capture images of the intervention.  All participants 
have signed a photo release forms for the APDA and will sign a photo release form for 
Washington University (Appendix 5). 
 
H2 Training  
Members of the research team will be trained in the assessments and/or how to assist 
during the dance classes prior to the start of the study. Testers will watch training videos, 
practice administering the tests, and perform a checkout assessment that is reviewed by 
an expert. 
H3 Case Report Forms and Source Documents 
NA 
H4 Records Retention 
Data collected under this protocol will be kept for a minimum of 7 years after the study is 
complete. 
H5 Performance Monitoring  
NA 
I Study Monitoring, Auditing, and Inspecting 
NA 
 
J Study Administration 
 
J1 Organization and Participating Centers 
This study will take place in the following locations: Washington University in St. Louis 
School and Medicine and the American Parkinson’s Disease Association St. Louis 
Chapter. 

 
 
 
 
 
 
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14
J2 Funding Source and Conflicts of Interest 
J3 Lee Silverman Voice Treatment (LSVT) Global is funding this research study.  
This means that Washington University is receiving payments from LSVT to 
support the activities that are required to conduct the study.  No one on the 
research team will receive a direct payment or increase in salary from LSVT for 
conducting this study.Committees 
NA 
J4 Subject Stipends or Payments  
Subjects will be given a checkfor participating in this study. 
J5  Study Timetable 
Recruitment will occur once the IRB is approved through approximately August 2019, 
and the study will begin in Semptember 2019. This will ensure ample time for 
participants to consider participating in the study. Participation in this study is completely 
voluntary and that will be verbally told to each participant and on the written consent. 
 
Prior to the start of the study, research team members will be trained and checked out 
on each assessment and the use of RedCap. 
 
Baseline testing will occur in late August 2019, allowing the intervention to begin in 
September 2019 and run for the following 12 weeks until November 2019.  Post testing 
will occur in that following week.  Due to the holiday season and school schedules, the 
control participants will begin the second wave of intervention in January 2020 until 
March of 2020. 
K Publication Plan  
 
The research team plans to publish findings from this study at its completion. 
 
 
L  Attachments  
 
L1 Tables 
Table 1. IMPROVment® Class Components 
Class 
Components 
Description  
Seated Exercise Class begins with all participants seated in a chair. Movement 
cues are given to move different parts of the body in different 
qualities (i.e. sharp and soft). This part of class serves as a warm 
up for the body prior to engaging in bigger movements. 
Standing Barre 
Work 
Movement progresses from a seated position to standing while 
still holding onto the chair for extra support. Barre work begins to 

 
 
 
 
 
 
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15
test balance abilities and increase level of movement executed 
(i.e. balancing on one leg). 
Across the Floor This is the section of class in which ID is incorporated most in 
several movement activities. These ID tasks are done both 
individually, in partners, and as a large group. Participants are not 
limited to staying close to their chairs and move around 
throughout the space using ID movement (i.e. moving in sync with 
another person in the room). 
 
Table 2. IMPROVment® Class Themes 
Class Themes Description 
Isolation Movement of a specific body part or parts. 
Shape How the body moves as a whole, as a combination of body parts, or as 
individual body parts. Shape can also be impacted by other objects in the 
environment (i.e. chairs, walls, other participants).  
Time The relationship between the body’s movement and music. Time can also be 
impacted by the movement of other participants.  
Flow The transition between movement, specifically the continuity of movement. 
Space/direction  The connection of movement to the physical environment. This is how 
movement is carried through space in both a stationary, seated position and 
locomotion throughout the classroom. 
Effort  The movement quality (i.e. light, heavy, free, structured). 
 
L2 Appendices  
Appendix 1: Inclusion/Exclusion Criteria Referral Form 
 
Inclusion/Exclusion Criteria Referral Form: IMPROVment® Class Participation  
 
PATIENT NAME:  ________________________ 
 
DATE:  _____________ 
PATIENT DOB:  _________________________ 
PARENTS NAMES: ________________________ 
ADDRESS:  _______________________________________________________ 
PHONE:  _______________________________ 
 
 
Inclusion Criteria 
          Yes 
          No 
- Age: 50+ 
          Yes 
          No 
- Parkinson’s Disease Diagnosis  
_____Yes 
_____No 
- Hoehn Yahr Score between 1 and 3 
_____Yes 
          No 
- Cognitive status: able to follow simple commands like  
_____Yes 
          No 
- Walks at least 3 meters independently   
 
 
 
Exclusion Criteria 
          Yes 
          No 
- History of adverse effects related to physical activity 
          Yes 
          No 
- Severe comorbidities 
 
 
 

 
 
 
 
 
 
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Appendix 2: Class Structure 
 

 
 
 
 
 
 
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Appendix 3: Adverse Event Reporting Form 
 

 
 
 
 
 
 
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Appendix 4: VAS Mood Scales 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
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Appendix 5: Washington University Photo/Image Release Form 
 

 
 
 
 
 
 
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L3  Informed consent documents 
 

 
 
 
 
 
 
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L4  Questionnaires and Written Assessments 
 
Quesitonnaire 1: Older Americans Resources and Services Scale- Extended Version 
(OARS-Ex) 

 
 
 
 
 
 
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Written Assessment 1: Unified Parkinson’s Disease Rating Scale (UPDRS) - III. MOTOR 
EXAMINATION    
 

 
 
 
 
 
 
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Written Assessment 2: Alternate Uses Tast 

 
 
 
 
 
 
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