DRAFT: This module has unpublished changes.
DRAFT: This module has unpublished changes.

Critical Appraisal Worksheet for an

Article about Therapy/Intervention

Adapted in part from U. Alberta EBM Toolkit; Oxford Centre for EBM

 B. Wiedermann, MD; Fetters & Tilson’s Evidence Based Physical Therapy

 

Patient Case Scenario:

Mrs. C is a 65 y/o female who sustained a R ACA CVA 5 weeks ago.  She is your new patient in an outpatient day rehabilitation program for individuals post-stroke.  Mrs. C presents with L LE weakness, poor balance, and impaired walking.  Her current walking speed is approximately 0.45 m/s (as measured by the 5m Walk Test), and she is limited to ambulation in her home with use of a quad cane.

 

Mrs. C’s primary goal for physical therapy is to improve her walking ability. “I want to be able to walk around in the community- like do my own grocery shopping and go to church on my own.”  She asks you, “What is the best physical therapy intervention for improving my walking ability?”

 

 

Develop a PICO question to guide your search for Mrs. C. (Hint: Make sure you have a foreground question!)

P:        In a 65 year old woman with a R CVA                                          

I:         is strength training more effective

C:        than a walking program

O:        for improving gait speed?

 

List the steps you took to search.  (Search terms, number of results/article “hits”, ways you modified the search, etc)

 

All mesh terms: “stroke” “resistance training” “aged” “women” “walking” = zero

All mesh terms: “stroke” “resistance training” “walking” = zero

“stroke (mesh)” “resistance training (mesh)” “gait speed” “walking program” = zero

“stroke (mesh)” “resistance training (mesh)” “walking program” = zero

“stroke (mesh)” “resistance training (mesh)” “gait speed” “treadmill” = one

“stroke (Mesh)” “resistance (Mesh)” “gait speed” = 7

 

Provide the Full Citation of Article you selected below. (Note: you will use the article assigned in class to complete the remainder of the worksheet!)

 

 

Mehta SPereira SViana RMays RMcIntyre AJanzen STeasell RW. Resistance training for gait speed and total distance walked during the chronic stage of stroke: a meta-analysis. Top Stroke Rehabil. 2012 Nov-Dec;19(6):471-8.

 

 

 


**Use the Nadeau et al. Effects of Task-Specific and Impairment-Based Training Compared with Usual Care on Functional Walking Ability After Inpatient Stroke Rehabilitation: LEAPS Trial. Neurorehabil Neural Repair. 2013, 27: 370.

 

Section 1:  Is this study applicable to my clinical question?

 

 

1.      Is the study’s purpose relevant to my clinical question?  Why or why not? Provide your rationale.

 

            This study is relevant because it compares usual care with a locomotor training program to a home exercise program which includes strength and balance exercises in improving people’s ability to improve walking speed, ability, and function post-stroke.  It answers my question very well.

 

Is the study population similar to my patient to justify that my patient would respond in a similar manner?   Yes

 

The study population is similar to my patient and I believe my patient would have similar results.  Mrs. C had a stroke 5 weeks ago, she is over 18, she has weakness in her L LE which is similar to residual paresis, and walks less than 0.8 m/sec. 

 

Characteristics that could prevent Mrs. C from having similar results would be if she has exercise contraindications, a preexisting neurological disorder, an inability to walk 10 feet, other major medical conditions that could affect her health, or had been unable to be independent in her ADLs prior to the stroke.

 

2.      Are the study’s intervention and comparison/control groups receiving a realistic intervention?  Yes

 

Yes, the LEAPS program isn’t adequately described in this article, however a quick google search lead me to the LEAPS protocol and it describes the interventions in detail. 

 

The LTP is described in the following paragraph:

 

“The program consists of 20–30 minutes of step training using the BWST modality with manual assistance provided by trainers, followed by 15 minutes of overground assessment and ambulation training 3×/week for 36 sessions. A 20–30 min period of actual stepping is the goal for the intervention sessions on the treadmill with rest periods as needed. Each training session may last up to 1 hour and 30 minutes including time for warm-up, stretching, and cool down. The overall goal is to enable the participant, by the end of training, to walk independently a total of 20 minutes in four, 5 minute bouts at 0.89 – 1.2 m/s (2.0 – 2.8 mph) and 0% BWS with good stepping kinematics. Good stepping is defined as walking with (1) an upright trunk with pelvic rotation to achieve limb loading, (2) symmetrical stride length, (3) symmetrical swing and stance time, (4) hip and knee flexion moments during swing initiation and swing, and (5) hip and knee extensor moments during stance and push-off with proper stance and swing kinematics” (Duncan, 2007).

 

The HEP which is 3 90-minute sessions performed each week for 12 weeks is described in the following paragraph:

 

“The exercise program is divided into three 4-week phases to provide the participants with a sense of progression. The first phase consists of upper extremity resistance exercise, lower extremity active exercises against no resistance, and sitting balance tasks. Each major joint of the upper and lower extremities is addressed. The second phase adds minimal resistance to the lower extremity, strengthening exercises, coordination tasks and static standing balance exercises. The third phase adds low repetitions of sit-to-stand practice and dynamic standing balance activities. At the end of each session, participants are encouraged to walk every day. Each participant is individually progressed according to their ability within each phase. Table 4 outlines examples of progression of exercises/activities. To ensure that all groups receive the same advice regarding the use of assistive devices for walking, the home exercise group participants are evaluated for assistive device needs after the 12th, 24th, and 36th session” (Duncan, 2007).  Please see attached description of progression of exercises.

 

The LTP is in an outpatient setting and performed by two physical therapists and a rehabilitation technician.  The HEP is performed by a physical therapist at home. 

 

The control was defined as “usual care” and was not monitored by the researchers.  This care was managed by practicing physical therapists across 6 sites in Florida and California.  Also, the HEP and LTP groups were permitted to receive any additional medical or physical therapy outside of the study. 

 

 

 

Section 2:  What is the overall methodological quality of the study?

 

            1. Does subject recruitment minimize bias? Why or why not?

 

Yes, it minimizes bias because the study screened 5289 stroke admissions in 6 different hospitals.  The sampling method employed is purposive sampling which is a non-probabilistic method because the participants are handpicked for survivors of stroke who meet all inclusion and exclusion criteria.  Purposive sampling is generally regarded as a representative sample of the population if the researchers used appropriate inclusion/exclusion criteria (Jewell, 2011).  The researchers in this study analyzed all possible patients of stroke at the hospitals and invited those who met reasonable inclusion criteria. 

  1.             2.  Was the allocation of subjects to treatment/comparison/control groups randomized?  Yes or no? Provide rationale (ex: If no, how were subjects allocated?)

            The article states the participants were allocated in stratified randomization at each site, further there were no significant site differences in the percentage of participants receiving the 3 treatments.

 

 

            3. Were all patients who entered the trial properly accounted for and attributed at its conclusion? Yes or no? Provide rationale (ex: Was follow-up complete? Was an intention to treat analysis performed for subjects who dropped out or did not complete the study?

 

Yes, the information is provided in Figure 1 of the article.  Figure 1 explains the allocation of patients, reasons why a number of patients did not finish the study, and states the number of patients who dropped out of the study and  the total number of participants included in the intention-to-treat analysis for each experimental and control group.  All participants who began the study were included in an intention-to-treat analysis.

 

            4. Were patients, their clinicians, and study personnel 'blind' to treatment?

 

The clinicians were not blinded to treatment because the different sites provided PT services to each group.  However, those physical therapists providing baseline and post-intervention assessments were blinded to the intervention group.

 

 

            5. Aside from the allocated treatment, were the groups treated equally?

Yes or no? Provide rationale.

 

Yes, each group was essentially treated similarly and equally.  The UC group was the control group so they didn’t receive any prescribed treatment from the researchers, but they had to record their PT visits in a log and communicate that to the researchers each month.  The HEP and LTP groups did not have to log or communicate their exercises to the researchers.  Beyond that the only differences in treatment were the interventions being studied.

 

 

Section 3:  How should I interpret the results?

 

 

  1. Were the study groups similar at baseline?  Yes or no?

 

The study provides Table 1 to examine the data, but did not provide easily decipherable statistics to compare within and between groups at baseline.  Further, the researchers provide no information that statistical tests were used to determine whether the participants were similar at baseline.  The Table 1 provides information on gender, race, age, ethnicity, education, stroke characteristics, stroke type, stroke severity, comorbidities, depression, MMSE score, walking disability, exercise tolerance test for each group (including those who dropped out of the study).  But the numbers provided are averages, percentages, and numbers.  There is no between or within group comparisons.  

 

  1. Were the outcome measures used reliable and valid? Yes or no? Provide rationale.

 

Yes, according to information provided in RehabMeasures.org the outcome measures used in this study are reliable and valid.  They have excellent to good inter-rater/intra-rater reliability, test-retest reliability for patients with stroke.  Most of these studies have a reported MCID, which improves interpretation of results.  These outcome measures have been proven through research to be valid for the stroke population.

 

  1. Was there a treatment effect?   Yes

If so, was it clinically relevant?  Yes

 

The study reports an odds ratio that those receiving LTP and HEP were 1.94 and 2.04 compared to the UC in achieving a higher functional walking level.  That means the patient receiving LTP or HEP were about twice as likely as achieving a higher functional walking level than those who received UC. 

 

The effect size of the LTP and HEP groups for walking speed relative to UC were 0.72 and 0.56, respectively.  These are defined as moderate effect sizes.  

 

Clinically significant improvements were found for all groups in regards to the SIS ADL/IADL, SIS Mobility, and Fast walking speed measurements (using the 10 min walk test MCID scores).  Only groups LTP and HEP had a clinically significant improvement in the 6-minute walk test.  These are evidenced in Table 4.  I was unable to find MCID values for the SIS Participation, Berg Score, Total Fugl-Meyer Score, and the Activities-Specific Balance Confidence score.

 

 There is no difference shown between the LTP and HEP average outcome changes as evidenced by the 95% CI, which is shown to include 1 in each measurement.  Further there is no significant difference between the LTP and UC average outcome changes in the step activity monitor, SIS Participation, SIS ADL/IADL, or the Fugl-Meyer.  This makes sense because all participants in each group were able to receive any additional PT services they desired and may have been receiving similar PT services to the UC group.  Also, the LTP group focused solely on LE gait training and these tests include testing of activities focused on UE use. 

 

Another interesting finding is between certain groups the average difference in outcome changes are more than the MCID.  I interpret this as meaning on average the difference in testing outcomes show a quite significant difference between groups, if a patient was in HEP they would be an MCID score more than the UC group in 3 areas.  That is evidence to me that the HEP is more beneficial than the UC group in slow and fast walking speed, SIS ADL/IADL, and SIS Mobility.  The LTP group had an average outcome score that was an MCID score higher than the UC group in slow and fast walking speed and SIS mobility.

 

I conclude this study reveals that HEP produces clinically significant improvements in patients versus UC in slow and fast walking speed, SIS ADL/IADL, and SIS Mobility while the LTP produces clinically significant improvements in patients compared to UC in slow and fast walking speed, SIS ADL/IADL, and SIS Mobility.  Also, there is not a difference in outcome scores between HEP and LTP.

 

Section 4:  How does this article inform my physical therapy practice?   

 

 

What is the clinical bottom line considering your clinical question and how your chosen article informs this question?*

 

This study examined which interventions best improved functional walking in patients recovering from stroke; task-specific walking training on a treadmill (LTP), progressive strength and balance exercise program (HEP), or usual care (UC).   For patients recovering from stroke, like Mrs. C, this study found LTP and HEP are nearly twice as likely to improve functional walking over UC.  They were found to be more beneficial than usual care in improving walking speed, ADL/IADLs, and general mobility.  A limitation in applying this study’s findings to Mrs. C is that I don’t know if each group had similar baseline characteristics; also if Mrs. C had impaired ADLs prior to her stroke, has serious comorbidities, can’t walk more than 10 feet, or exercise intolerance the study’s findings may not effect Mrs. C as well as the participants in the study.  I will incorporate the exercise progression described in the HEP program and the treadmill use described in the LTP in my treatment of patients who are recovering from stroke and have a goal of improving functional walking. 

 

 

*Response should be succinct, accurate, and written in narrative form.

 

 

Resources:

 

Duncan, et al. Protocol for the Locomotor Experience Applied Post-stroke (LEAPS) trial: a randomized controlled trial. BMC Neurology. 2007, 7:39.

 

Jewell, Diane. Guide to Evidence-Based Physical Therapist Practice, 2nd ed. Richmond, VA: Jones and Bartlett Learning; 2011. 

 

DRAFT: This module has unpublished changes.