This randomized controlled trial compared the LSVT BIG program to a general exercise program in 11 patients with early-stage Parkinson's disease. Participants were randomly assigned to groups and received their assigned exercise program for 4 weeks. Outcome measures assessing motor and non-motor symptoms were collected at baseline, 4 weeks, 3 months, and 6 months. The study found a small effect favoring LSVT BIG over general exercise for motor symptoms, but the small sample size limits conclusions. Overall, the evidence from this and two other studies was insufficient to show that LSVT BIG decreases motor symptoms more than traditional physical therapy for patients with Parkinson's disease.

1. Assignment #4
December 14, 2015
In patients with Parkinson’s disease, does Lee Silverman Voice Training (LSVT) BIG
Program demonstrate more of a decrease in motor symptoms than traditional
physical therapy?

2. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 1
I. A
randomized control study that compared LSVT BIG therapy to an exercise
program that included only treadmill and seated exercises. It had 11 participants
with Parkinson’s disease divided into two groups performing the exercises for 4
weeks. The study looked at the change of motor and nonmotor symptoms.¹
A. Strengths
1. The exercise intensity of the General Exercise group were
measured by the Borg rating of perceived exertion. This allowed
all participants to work at a consistent level instead of some
exercises being harder on some patients due to age, condition
level, etc.
2. Because the LSVT BIG program requires one-on-one interaction
with a PT, this study chose to allow the General Exercise group to
also work one-on-one with a PT thus minimize the internal threat
of Hawthorne effect.
3. This study was double-blinded, minimizing placebo effect and
experimenter bias which are both internal threats.
4. Measurements were taken at baseline, 4 weeks, 3 months, and
6 months to see any changed between the groups through time.
B. Weaknesses
1. There was a small sample size for this study (11 participants)
which leads to an increased risk of type II error, low power, and
low effect size.
2. All the participants in the study were in the early stage of PD so
the more severe effects were not studied in this trial.
3. This study excluded participants who had atypical PD, who
were already participating in an exercises program, and those
with evidence of severe depression. This is an example of the
external threat of sample bias which makes the study difficult to
generalize to the public
4. The General Exercise group combined treadmill training with
seated exercise. This is considered multiple treatment
interference and is an example of an external threat.
II. A randomized control trial that compared LSVT BIG to a short protocol
including multidirectional movements and working on ADLs. The study had 42
patients with Parkinson’s disease who received either 16 sessions of LSVT BIG or
10 sessions of a short protocol. The study compared the effects of these
exercises on motor and nonmotor effects.²
A. Strengths
1. Examiners found by conducting a power analysis that they
needed 17 participants per group and were able to recruit 21

3. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 2
people for each group which decreased the chance of a type II
error.
2. Participants were assigned to groups using a random drawing
to ensure randomization of groups minimizing internal threats to
selection.
3. To ensure blinded assessment, the patients were videotaped
while performing the UPDRS-III items minimizing experimenter
bias.
4. During examination, the examiner was blinded not only to
group allocation but also to the time the video was taken which
decreases experimenter bias.
B. Weaknesses
1. Patients for this study were referred by clinics and physicians
but the article does not state how the participants were chosen.
Without knowing the recruiting method, we are not
able to infer the condition of the participants related to those
who were not recruited.
2. Participants were excluded if they had dementia, severe
depression, disabling dyskinesia, and co-morbidity affecting
mobility or ability to exercise. Excluding these participants makes
it harder to generalize this study to the public.
3. The two groups received treatment for different lengths of
time. The LSVT-BIG group received 16 1-hour sessions (4/week for
4 weeks) and the short protocol group received 10 1-hour
sessions (5/week for 2 weeks).
4. The post-treatment measurements were taken 16 weeks after
the interventions were started. Because the groups had
different durations of treatment time, the groups were not being
measured at equal times from cessation of treatment.
III. A study comparing LSVT BIG to a walking program and a home exercise
program for a change in motor and nonmotor symptoms. The study had 60
participants evenly divided into three groups. LSVT BIG and the walking group
each had 16 exercise sessions.³
A. Strengths
1. The participants chosen for the study fit the inclusion/exclusion
criteria as to rule out any alternative explanation for getting
better or worse. This decreases a selection threat.
2. The study had 60 participants reducing the chance of a type II
error.
3. This study divided up participants randomly with no differences
noted between groups decreasing a selection threat.
4. This study was blinded to the rater so to minimize the risk of
the internal threat of experimenter bias.

4. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 3
B. Weaknesses
1. In this study, the groups completed their intervention for
different amounts of time. The BIG group had 1 hour sessions 4
times a week for 4 weeks while the WALK group had 1 hour
sessions 2 times a week for 8 weeks. The article did not state how
often the HOME group was to perform their exercises and for
what duration.
2. The BIG group had one-on-one interactions with the PT while
the WALK group had group sessions and the HOME group had no
interaction with a PT. This is an example of the Hawthorne effect
which is an internal threat.
3. Patients were allowed to perform additional exercises during
the study and six participants had changes in their medications
during the study. This is an internal threat which could lead to
alternative explanations for the results.
4. The WALK group performed their intervention in a park which is
not similar to a real clinical situation.
IV. The review of these three RTC leads me to fail to reject the null of my
study question. Only one of the studies showed that LSVT BIG improved motor
performance better than traditional physical therapy. Of the other two studies,
one was unable to detect a difference between the two groups and the other
showed that the motor assessment did not differ between the groups.
I also considered the magnitude of effects of the results of the studies
when answering my clinical question. The first study¹ had a magnitude of effect
of 0.20. It resulted from considerable overlap between data scores and a low
sample size. The magnitude of effect of the next study² was 0.41. The last, and
most complex study³ had a magnitude of effect of 0.62 between the LSVT BIG
group and the WALK group, 0.56 between LSVT BIG and HOME, and 0.11
between WALK and HOME.
These studies failed to show that LSVT BIG has an effect on motor
symptoms in patients with Parkinson’s disease (PD). When treating a patient
with PD, I would not spend the time and money to either become LSVT BIG
certified or find a PT who is since traditional PT shows similar effects. Traditional
PT can still have a positive effect on these patients and improve their mobility
and other motor symptoms they may be experiencing.
In future studies, more participants are needed with a wider variety of
disease levels to be able to generalize the study to the public more easily. Only
two interventions should be compared at a time. Lastly, the interventions should
be given for the same amount of time and in a one-on-one basis to increase
validity and decrease the threats listed in the outline above.

5. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 4
1. Khashayar D, Johnson E, Kani C, et al. Effect of exercise on motor and
nonmotor symptoms of Parkinson’s disease. Parkinsons Dis. 2015; 586378.
2. Ebersbach G, Grust U, Ebersbach A, et al. Amplitude-oriented exercises in
Parkinson’s disease: a randomized study comparing LSVT-BIG and a short
training protocol. J of Neural Trans. 2015; 122:253-256.
3. Ebersbach G, Ebersbach A, Edler D, et al. Comparing exercise in Parkinson’s
disease-the Berlin LSVT BIG study. Mov Dis. 2010; 25:1902-1908.

6. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 5
Student ID#: 14147292
Primary Reference: Khashayar D, Johnson E, Kani C, et al. Effect of exercise on
motor and nonmotor symptoms of Parkinson’s disease. Parkinsons Dis. 2015;
586378.
Worksheet for Critical Appraisal
(based on PEDro http://www.pedro.org.au/english/tutorial/is-the-trial-valid/ and
http://www.ncbi.nlm.nih.gov/pubmed/14703546?dopt=AbstractPlus, which is
referred to as a resource by Centre for Evidence Based Medicine )
Instructions. Indicate the correct response by shading it and/or providing an
explanation where such a response is requested. If the article did not provide
sufficient information for you to be moderately confident about the answer,
then add “NS” as an abbreviation for “not stated.” Focus only the methods and
results that match your clinical question. You will use and submit this worksheet
for Assignments #3 and 5. To make the narrative portion of Assignment #5
easier, please add your own notations inside brackets (e.g., [ ]) to this worksheet.
Your notes on this actual worksheet will not be graded. Note. The types of
statistical analyses conducted should not to be appraised and the statistical
results of a study are neither methodological strengths or weaknesses. Also, “not
stated” information is not a weakness for our purposes.
 Does the “P” population (patients) of interest in your clinical question match
the actual sample of the study? Yes No
 Does the “I” intervention in your clinical question match one of the
interventions in the study? Yes No
 Does the “C” comparison in your clinical question match one of the
comparisons in the study? Yes No
 Does the “O” outcome measure/s in your clinical question match one or
more of the outcome measures in the study? Yes No
Population/patients
 Is the source from which participants were recruited (e.g., physicians)
described? Yes No
 Is the method of recruiting (e.g., flyers) participants described? Yes No
 Is the method of sampling (e.g., convenience) participants described or
discernable? Yes No
 Is the percentage of participants (i.e., enrolled/consented to participate)
from among the recruits and/or eligible recruits (i.e., met inclusion/exclusion
criteria) provided or calculable? Yes No

7. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 6
 Were the eligibility criteria (i.e., inclusion/exclusion) appropriate to match
your “P”? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Were the eligibility criteria appropriate to reduce alternative explanations for
the results (i.e., extraneous variables)? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
Methodological weaknesses/threats related to “P”: Patients for this study were
referred by clinics and physicians but the article does not state how the
participants were chosen. Without knowing the recruiting method, we are not
able to infer the condition of the participants related to those who were not
recruited. This is an example of an internal threat. There was also a small sample
size for this study (11 participants) which leads to an increased risk of type II
error, low power, and low effect size. Lastly, all the participants in the study
were in the early stage of PD so the more severe effects were not studied in this
trial.
Methodological strengths related to “P”: The participants chosen for the study fit
the inclusion/exclusion criteria as to rule of any alternative explanation for
getting better or worse. This is minimizing an internal threat.
Intervention (and Comparison)
 What research design best matches the design of the study?
 Cross sectional (survey)
 Cross sectional (analytic)
 Case-control
 Cohort study
 Randomized crossover
 Randomized controlled trial (RCT)
Note. It is very unlikely that a “NS” response is acceptable.
 Was the comparison group (between)/condition (within) appropriate to
answer the actual research question? For example, real ultrasound compared
to sham ultrasound. Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Were the participants randomly allocated to groups/conditions? Yes No
 If the design had groups, were the groups similar (e.g., matched) at baseline?
Yes No NA
 Were the participants aware of other participants’ groups/conditions?
Yes No
 Was the intervention /comparison reasonably controlled to reduce
extraneous variables? Yes No

8. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 7
Note. It is very unlikely that a “NS” response is acceptable.
 Was the percentage of the enrolled participants who adhered to the
intervention/comparison provided (e.g., number of intervention sessions
attended) or calculable? Yes No
 Was the setting for the study (e.g., community PT clinic) similar to a real
clinical situation? Yes No
Methodological weaknesses/threats related to “I/C”: This study excluded
participants who had atypical PD, who were already participating in an exercises
program, and those with evidence of severe depression. This is an example of
the external threat of sample bias and can make the study difficult to generalize
to the public.
Methodological strengths related to “I/C”: The exercise intensity of the General
Exercise group were measured by the Borg rating of perceived exertion. This
allowed all participants to work at a consistent level instead of some exercises
being harder on some patients due to age, condition level, etc. Because the LSVT
BIG program requires one-on-one interaction with a PT, this study chose to allow
the General Exercise group to also work one-on-one with a PT thus minimize the
internal threat of Hawthorne effect. Lastly, there was a low mortality rate since
all 11 participants completed the trial.
Outcome Measures
 Were the outcomes measured appropriate to answer the study’s research
question? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Were references for the reliability/validity of the outcome measures
provided? Yes No
 Were references for the Minimum Clinically Important Difference (MCIDs) of
the outcome measures provided? Yes No
 Were the outcome measures collected appropriately for reliability and
validity (e.g., bony landmarks used)? Yes No
 Were the time points for collecting the outcome measures (i.e., testing
intervals and study duration) appropriate to answer the actual research
question? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Were the outcome measures collected commonly used in real clinical
situations? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Was the investigator/s, who collected the measures, blinded to participants’
group? Yes No

9. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 8
 Was the percentage of participants who completed the outcome measure(s)
provided or calculable? Yes No
Describe the magnitude of effects (e.g., differences in changes between
groups/conditions in relation to the average variability (SDs) of the groups)
regardless of p-value. For example, you might write, “The difference between
the means of the two groups at the follow-up measure was about 1/3 of the
average SD of the two groups, which seems clinically meaningful based on MCIDs
and/or my clinical expertise with the measure.” When comparing the means and
SDs of the two groups, an effect size of 0.20 was calculated. This says there was a
lot of overlap in the data and the effect size is very small.
Methodological weaknesses/threats related to “O”: The General Exercise group
combined treadmill training with seated exercise. This is considered multiple
treatment interference and is an example of an external threat.
Methodological strengths related to “O”: The study was double-blinded,
minimizing placebo effect and experimenter bias which are both internal threats.
Measurements were taken as baseline, 4 weeks, 3 months, and 6 months to see
any changed between the groups through time.
(Note. When in doubt about what is “reasonable/appropriate” consider a real
clinical situation and/or compare several studies answering similar research
questions with similar research designs.)

10. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 9
Student ID#: 14147292
Primary Reference: Ebersbach G, Grust U, Ebersbach A, et al. Amplitude-
oriented exercises in Parkinson’s disease: a randomized study comparing LSVT-
BIG and a short training protocol. J of Neural Trans. 2015; 122:253-256.
Worksheet for Critical Appraisal
(based on PEDro http://www.pedro.org.au/english/tutorial/is-the-trial-valid/ and
http://www.ncbi.nlm.nih.gov/pubmed/14703546?dopt=AbstractPlus, which is
referred to as a resource by Centre for Evidence Based Medicine )
Instructions. Indicate the correct response by shading it and/or providing an
explanation where such a response is requested. If the article did not provide
sufficient information for you to be moderately confident about the answer,
then add “NS” as an abbreviation for “not stated.” Focus only the methods and
results that match your clinical question. You will use and submit this worksheet
for Assignments #3 and 5. To make the narrative portion of Assignment #5
easier, please add your own notations inside brackets (e.g., [ ]) to this worksheet.
Your notes on this actual worksheet will not be graded. Note. The types of
statistical analyses conducted should not to be appraised and the statistical
results of a study are neither methodological strengths or weaknesses. Also, “not
stated” information is not a weakness for our purposes.
 Does the “P” population (patients) of interest in your clinical question match
the actual sample of the study? Yes No
 Does the “I” intervention in your clinical question match one of the
interventions in the study? Yes No
 Does the “C” comparison in your clinical question match one of the
comparisons in the study? Yes No
 Does the “O” outcome measure/s in your clinical question match one or
more of the outcome measures in the study? Yes No
Population/patients
 Is the source from which participants were recruited (e.g., physicians)
described? Yes No
 Is the method of recruiting (e.g., flyers) participants described? Yes No

11. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 10
 Is the method of sampling (e.g., convenience) participants described or
discernable? Yes No
 Is the percentage of participants (i.e., enrolled/consented to participate)
from among the recruits and/or eligible recruits (i.e., met inclusion/exclusion
criteria) provided or calculable? Yes No
 Were the eligibility criteria (i.e., inclusion/exclusion) appropriate to match
your “P”? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Were the eligibility criteria appropriate to reduce alternative explanations for
the results (i.e., extraneous variables)? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
Methodological weaknesses/threats related to “P”: Patients for this study were
referred by clinics and physicians but the article does not state how the
participants were chosen. Without knowing the recruiting method, we are not
able to infer the condition of the participants related to those who were not
recruited. This is an example of an internal threat. Participants were excluded if
they had dementia, severe depression, disabling dyskinesia, and co-morbidity
affecting mobility or ability to exercise. Excluding these participants makes it
harder to generalize this study to the public.
Methodological strengths related to “P”. Examiners found by doing a power
analysis that they needed 17 participants per group and were able to recruit 21
people for each group which decreased the chance of a type II error.
Intervention (and Comparison)
 What research design best matches the design of the study?
 Cross sectional (survey)
 Cross sectional (analytic)
 Case-control
 Cohort study
 Randomized crossover
 Randomized controlled trial (RCT)
Note. It is very unlikely that a “NS” response is acceptable.
 Was the comparison group (between)/condition (within) appropriate to
answer the actual research question? For example, real ultrasound compared
to sham ultrasound. Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Were the participants randomly allocated to groups/conditions? Yes No
 If the design had groups, were the groups similar (e.g., matched) at baseline?

12. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 11
Yes No NA
 Were the participants aware of other participants’ groups/conditions?
Yes No
 Was the intervention /comparison reasonably controlled to reduce
extraneous variables? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Was the percentage of the enrolled participants who adhered to the
intervention/comparison provided (e.g., number of intervention sessions
attended) or calculable? Yes No
 Was the setting for the study (e.g., community PT clinic) similar to a real
clinical situation? Yes No
Methodological weaknesses/threats related to “I/C”: The two groups received
treatment for different lengths of time. The LSVT-BIG group received 16 1-hour
sessions (4/week for 4 weeks) and the short protocol group received 10 1-hour
sessions (5/week for 2 weeks). This could increase the chance of an internal
threat.
Methodological strengths related to “I/C”: Participants were assigned to groups
using a random drawing to ensure randomization of groups minimizing internal
threats. Inclusion/exclusion criteria was also used to minimize internal threats.
By making the participants as similar as possible, the researcher decreased the
chance of other explanations for changes between groups.
Outcome Measures
 Were the outcomes measured appropriate to answer the study’s research
question? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Were references for the reliability/validity of the outcome measures
provided? Yes No
 Were references for the Minimum Clinically Important Difference (MCIDs) of
the outcome measures provided? Yes No
 Were the outcome measures collected appropriately for reliability and
validity (e.g., bony landmarks used)? Yes No
 Were the time points for collecting the outcome measures (i.e., testing
intervals and study duration) appropriate to answer the actual research
question? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Were the outcome measures collected commonly used in real clinical
situations? Yes No
Note. It is very unlikely that a “NS” response is acceptable.

13. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 12
 Was the investigator/s, who collected the measures, blinded to participants’
group? Yes No
 Was the percentage of participants who completed the outcome measure(s)
provided or calculable? Yes No
Describe the magnitude of effects (e.g., differences in changes between
groups/conditions in relation to the average variability (SDs) of the groups)
regardless of p-value. For example, you might write, “The difference between
the means of the two groups at the follow-up measure was about 1/3 of the
average SD of the two groups, which seems clinically meaningful based on MCIDs
and/or my clinical expertise with the measure.” When comparing the means and
SDs of the two groups, an effect size of 0.41 was calculated. This is a small effect
size.
Methodological weaknesses/threats related to “O”: The post-treatment
measurements were taken 16 weeks after the interventions were started.
Because the groups had different durations of treatment time, the groups were
not being measured at equal times from cessation of treatment. This could be
alternative explanations for the results.
Methodological strengths related to “O”: To ensure blinded assessment, the
patients were videotaped while performing the UPDRS-III items minimizing
experimenter bias. Also during examination, the examiner was blinded not only
to group allocation but also to the time the video was taken.
(Note. When in doubt about what is “reasonable/appropriate” consider a real
clinical situation and/or compare several studies answering similar research
questions with similar research designs.)

14. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 13
Student ID#: 14147292
Primary Reference: Ebersbach G, Ebersbach A, Edler D, et al. Comparing exercise
in Parkinson’s disease-the Berlin LSVT BIG study. Mov Dis. 2010; 25:1902-1908.
Worksheet for Critical Appraisal
(based on PEDro http://www.pedro.org.au/english/tutorial/is-the-trial-valid/ and
http://www.ncbi.nlm.nih.gov/pubmed/14703546?dopt=AbstractPlus, which is
referred to as a resource by Centre for Evidence Based Medicine )
Instructions. Indicate the correct response by shading it and/or providing an
explanation where such a response is requested. If the article did not provide
sufficient information for you to be moderately confident about the answer,
then add “NS” as an abbreviation for “not stated.” Focus only the methods and
results that match your clinical question. You will use and submit this worksheet
for Assignments #3 and 5. To make the narrative portion of Assignment #5
easier, please add your own notations inside brackets (e.g., [ ]) to this worksheet.
Your notes on this actual worksheet will not be graded. Note. The types of
statistical analyses conducted should not to be appraised and the statistical
results of a study are neither methodological strengths or weaknesses. Also, “not
stated” information is not a weakness for our purposes.
 Does the “P” population (patients) of interest in your clinical question match
the actual sample of the study? Yes No
 Does the “I” intervention in your clinical question match one of the
interventions in the study? Yes No
 Does the “C” comparison in your clinical question match one of the
comparisons in the study? Yes No
 Does the “O” outcome measure/s in your clinical question match one or
more of the outcome measures in the study? Yes No
Population/patients
 Is the source from which participants were recruited (e.g., physicians)
described? Yes No
 Is the method of recruiting (e.g., flyers) participants described? Yes No
 Is the method of sampling (e.g., convenience) participants described or
discernable? Yes No
 Is the percentage of participants (i.e., enrolled/consented to participate)
from among the recruits and/or eligible recruits (i.e., met inclusion/exclusion
criteria) provided or calculable? Yes No
 Were the eligibility criteria (i.e., inclusion/exclusion) appropriate to match
your “P”? Yes No

15. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 14
Note. It is very unlikely that a “NS” response is acceptable.
 Were the eligibility criteria appropriate to reduce alternative explanations for
the results (i.e., extraneous variables)? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
Methodological weaknesses/threats related to “P”: Patients for this study were
referred by clinics and physicians but the article does not state how the
participants were chosen. Without knowing the recruiting method, we are not
able to infer the condition of the participants related to those who were not
recruited. This is an example of an internal threat.
Methodological strengths related to “P”: The participants chosen for the study fit
the inclusion/exclusion criteria as to rule of any alternative explanation for
getting better or worse. This is minimizing an internal threat. The study had 60
participants reducing the chance of a type II error.
Intervention (and Comparison)
 What research design best matches the design of the study?
 Cross sectional (survey)
 Cross sectional (analytic)
 Case-control
 Cohort study
 Randomized crossover
 Randomized controlled trial (RCT)
Note. It is very unlikely that a “NS” response is acceptable.
 Was the comparison group (between)/condition (within) appropriate to
answer the actual research question? For example, real ultrasound compared
to sham ultrasound. Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Were the participants randomly allocated to groups/conditions? Yes No
 If the design had groups, were the groups similar (e.g., matched) at baseline?
Yes No NA
 Were the participants aware of other participants’ groups/conditions?
Yes No
 Was the intervention /comparison reasonably controlled to reduce
extraneous variables? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Was the percentage of the enrolled participants who adhered to the
intervention/comparison provided (e.g., number of intervention sessions
attended) or calculable? Yes No

16. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 15
 Was the setting for the study (e.g., community PT clinic) similar to a real
clinical situation? Yes No
Methodological weaknesses/threats related to “I/C”: In this study, the groups
completed their intervention for different amounts of time. The BIG group had 1
hour sessions 4 times a week for 4 weeks while the WALK group had 1 hour
sessions 2 times a week for 8 weeks. The article did not state how often the
HOME group was to perform their exercises and for what duration. Also, the BIG
group had one-on-one interactions with the PT while the WALK group had group
sessions and the HOME group had no interaction with a PT. This is an example of
the Hawthorne effect which is an internal threat. Also, patients were allowed to
perform additional exercises during the study and six participants had changes in
their medications during the study. This is an internal threat which could lead to
alternative explanations for the results. Lastly, the WALK group performed their
intervention in a park which is not similar to a real clinical situation.
Methodological strengths related to “I/C”: This study divided up participants
randomly with no differences noted between groups. This minimized the risk for
internal threats such as statistical regression and selection.
Outcome Measures
 Were the outcomes measured appropriate to answer the study’s research
question? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Were references for the reliability/validity of the outcome measures
provided?
Yes No
 Were references for the Minimum Clinically Important Difference (MCIDs) of
the outcome measures provided? Yes No
 Were the outcome measures collected appropriately for reliability and
validity (e.g., bony landmarks used)? Yes No
 Were the time points for collecting the outcome measures (i.e., testing
intervals and study duration) appropriate to answer the actual research
question? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Were the outcome measures collected commonly used in real clinical
situations? Yes No
Note. It is very unlikely that a “NS” response is acceptable.
 Was the investigator/s, who collected the measures, blinded to participants’
group? Yes No

17. In patientswithParkinson’sdisease,doesLee SilvermanVoice Training(LSVT) BIG
Program demonstrate more of adecrease in motorsymptomsthantraditional physical
therapy. 16
 Was the percentage of participants who completed the outcome measure(s)
provided or calculable? Yes No
Describe the magnitude of effects (e.g., differences in changes between
groups/conditions in relation to the average variability (SDs) of the groups)
regardless of p-value. For example, you might write, “The difference between
the means of the two groups at the follow-up measure was about 1/3 of the
average SD of the two groups, which seems clinically meaningful based on MCIDs
and/or my clinical expertise with the measure.” When comparing the means and
the SDs of LSVT BIG and WALK, an effect size of 0.62 was found. This is
considered a medium/big effect size. When comparing LSVT BIG and HOME, an
effect size of 0.56 was found. Lastly, when WALK and HOME were compared, an
effect size of 0.11 was found which is considered a small effect size. These were
calculated based only on the UPDRS III which was the main measure of the
study.
Methodological weaknesses/threats related to “O”: The post-treatment
measurements were taken 16 weeks after the interventions were started.
Because the groups had different durations of treatment time, the groups were
not being measured at equal times from cessation of treatment. This could be
alternative explanations for the results. Lastly, one of the result measurements
was the timed up-and-go. Because this is a walking task, the participants in the
WALK group had more indirect practice with this skill than the other 2 groups.
This is an example of the internal threat of testing.
Methodological strengths related to “O”: This study was blinded to the rater so
to minimize the risk of the internal threat of experimenter bias.
(Note. When in doubt about what is “reasonable/appropriate” consider a real
clinical situation and/or compare several studies answering similar research
questions with similar research designs.)