CRITICALLY APPRAISED PAPER (CAP) WORKSHEET
QUESTION (Chapter 1):
Does sound wave vibration therapy in addition to physical therapy decrease spasticity and increase gross motor function compared to just physical therapy in children with spastic Cerebral Palsy?
CITATION AND DOI NUMBER:
Katusik, A., Alimovic, S., & Mejaski-Bosnjak, V. (2013). The effect of vibration therapy on spasticity and motor function in children with cerebral palsy: A randomized controlled trial. NeuroRehabilitaiton, 32, 1-8.
DOI: 10.3233/NRE-130817
CLINICAL BOTTOM LINE (do last): In this section provide, in your own words: (1) how the evidence relates to your discipline (PT or OT); (2) how can the PT or OT use the evidence relative to the target population and practice setting?
This evidence of vibration therapy benefitting children with spastic Cerebral Palsy relates to physical therapy as this is a patient population that requires PT services from a young age. As physical therapists, it is important to always be searching for new evidence that supports new interventions that can benefit the patients you’re working with. The evidence in this study provides physical therapists with a proven new intervention that can reduce spasticity and increase motor function in children with CP. If more research on vibration therapy is conducted, and it continues to have positive results, the treatment can be incorporated into a child’s physical therapy program. By utilizing this new research in addition to physical therapy, it is possible to increase the quality of life for children with CP.
RESEARCH HYPOTHESIS (Chapter 3):
The hypothesis of this research is that in three months the intervention group who received sound-wave vibration treatment in addition to their normal PT program would show reduced levels of spasticity and increased gross motor function compared to the control group.
LEVEL OF EVIDENCE (Chapter 1 – using levels of evidence discussed in class):
Level 2: This study is a randomized controlled trial.
DESIGN (Chapter 6)
Study Notation:
R OP Xa + Xb OP
R OP Xa OP
SAMPLE SELECTION: How were subjects recruited and selected to participate. Please describe.
Inclusion Criteria:
– Children had to be classified as having spastic cerebral palsy by neurological evaluation is accordance with Surveillance of Cerebral Palsy in Europe (SCPE).
– Children had to be between 4 and 6 at the start of the study.
– They had to be currently receiving physical therapy.
– They had to have no planned surgeries or other significant comorbidities that would interfere with the rehabilitation program.
Exclusion Criteria:
– Children were excluded if they did not meet all of the inclusion criteria. No other exclusions were specifically stated.
SAMPLE CHARACTERISTICS:
N = (number of participants taking part in the study): 89
#/ (%) Male: 52/58% #/ (%) Female: 37/42%
Ethnicity: Not stated, however the study took place in Zagreb, Croatia.
Disease/disability diagnosis: Spastic Cerebral Palsy
INTERVENTION(S) AND CONTROL GROUPS – if needed, add groups if necessary
Group 1
Brief description of intervention: The intervention group received 3 sessions of 40 minutes per week of physical therapy. Additionally, they received sound based vibration therapy for twenty minutes twice per week.
How many participants in the group? 45
Where did the intervention take place? The intervention took place a day-care center by the name of “Mali dom-Zagreb”.
Who delivered? PT was delivered by physical therapists who were blinded to the group assignments. Vibration therapy was administered in one-on-one sessions using vibroacoustic bedpans.
How often? PT 3 times a week. Vibration therapy twice a week.
For how long? PT for 40 minutes per session. Vibration for 20 minutes per session.
Group 2
Brief description of intervention/control condition: The control group received 3 sessions of 40 minutes per week of physical therapy.
How many participants in the group? 44
Where did the intervention/examination/outcome measure take place? The intervention, control treatment, and outcome measures took place at a day-care center by the name of “Mali dom-Zagreb”.
Who delivered? PT was delivered by physical therapists who were blinded to the group assignments.
How often? PT 3 times a week.
For how long? 40 minutes per session.
OUTCOMES (Chapter 7)
Complete for primary outcome measures relevant to physical or occupational therapy (select three most important outcomes if more than three):
Measure 1:
Name of measure used: Modified Modified Ashworth Scale (MMAS)
What outcome was measured? Spasticity of the elbow and wrist flexors, hip adductors, knee extensors, and plantar flexors. Standardized test positioning and procedures were used. The scores were calculated by combining bilateral scores and ranged from 0-40.
Is the measure reliable? yes no NR
Is the measure valid? yes no NR
The study explicitly states that the MMAS has good reliability and validity in the measurements section (2.3). The cited the study by Ghotbi, Ansari, Naghdi, & Hasson, 2011 to show MMAS reliability and validity.
When is the measure used? The MMAS was performed before any intervention took place, and after the 12-week trial period. Two physical therapists performed the tests and were blinded to group assignment. Both PT’s were experienced and trained in the use of the measures.
Measure 2:
Name of measure used: Gross Motor Function Measure (GMFM-88).
What outcome was measured? The GMFM-88 measures a change in gross motor function with 88 tasks in 5 categories. The categories are lying and rolling, sitting, crawling and kneeling, standing, and walking, running, and jumping. The GMFM scores are calculated by combining scores from each category and can range from 0-100.
Is the measure reliable? yes no NR
Is the measure valid? yes no NR
The study explicitly states the reliability and validity of the GMFM has been shown to be good in children with CP by citing a study by Russel, Avery, Rosenbaum, Raina, Walter, & Palisano, 2000.
When is the measure used? The GMFM was performed before any intervention took place, and after the 12-week trial period. Two physical therapists performed the tests and were blinded to the group assignment. Both PT’s were experienced and trained in the use of the measures.
Biases/Threats to Validity: (Chapter 5) Circle yes, no or NR and explain.
History: yes no NR
Explain: the trial only occurred over 12 weeks so there was not a high risk for events to happen between the pre-test and post-test. Any events that did occur were protected against by having a control group that prevented exposure to alternative therapies.
Hawthorne effect: yes no NR
Explain: The intervention group received 40 extra minutes of therapy per week that were not accounted for in the control group. The intervention group received extra attention and knew they were receiving the intervention as opposed to the control.
Assignment/selection: yes no NR
Explain: The participants were randomly assigned and participant matching occurred using the GMFCS for ages 4-6 to ensure similar functional levels of each group.
Maturation: yes no NR
Explain: The study only took place over 3 months which is not long enough to see changes in development or healing.
Mortality/attrition: yes no NR
Explain: Only 12 participants of the 101 who were initially recruited were lost to follow up or unable to attend the full treatment due to illness. This left 89 participants, which is still a large enough number to ensure the study is not affected by those who dropped out. The participants who dropped out were not included in the statistical analysis of the trial.
Measurement Biases
Were the evaluators blind to treatment status? Circle yes, no, or NR, and explain
Yes No NR
Comment:
The physical therapists who were providing PT services to both the intervention and the control group did not know which group each participant was in. Additionally, the PT’s performing the outcome measures did not know which group each participant was in.
Testing/practice bias. Circle yes, no, or NR, and explain
Yes No NR
Comment:
Testing/practice bias was protected against by having the control group and MMAS and GMFM have good test/retest reliability.
RESULTS (Chapter 4, 5 and 6)
List key findings based on study objectives
The change in spasticity was reported as significant in both groups, however the intervention group showed a greater change. The control group showed an average decrease of 2 points and the intervention group showed an average decrease of 4 points. The change scores favor the intervention group with a p value <0.001. The CMFM-88 increased in both groups as well, but favored the intervention group with a p value of <0.001. The control group increased by an average of 2.2 and the intervention group increased by an average of 3.6. Effect size was not reported.
Were the two groups comparable on key demographics and outcome measures at the beginning of the study?
Circle yes, no, or NR, and explain
Yes No NR
Comment:
The study utilized strict inclusion criteria and had comparable participants in terms of demographics in each group. Groups were also equalized using the Gross Motor Function Classification System for 4 to 6-year-olds to balance the groups functional levels at the beginning of the study. The study explicitly states in the results section that there were no significant differences in any variables at baseline.
Was this study adequately powered (large enough to show a difference)? Circle yes, no, or NR, and explain
Yes No NR
Comment: The study stated that is has a power of 95%. The study needed 70 participants to satisfy a mean of 2.8 and a standard deviation of 3.2 on the GMFM-88. The study had 89 participants so it went well beyond the needed 70. This concluded that the mean change of 2.8 is considered clinically meaningful change.
Were protections against fishing threats put in place? Circle yes, no, or NR and explain
Yes No NR
Comment: No Bonferroni correction was included in the statistical analysis of the experiment. This study was only completed one time with one group of participants so it is at risk of a Type 1 Error.
Were appropriate analytic methods used? Circle yes, no, or NR, and explain
Yes No NR
Comment: The study states that they used a Wilcoxon Matched Pairs test to analyze differences over time and a Mann-Whitney U-test to analyze the differences between the two groups. The study used a .05 level of significance.
Were statistics appropriately reported (in written or table format)? Was the interaction effect reported? Circle yes, no, or NR, explain
Yes No NR
Comment: Yes and No. The statistics were appropriately reported in table and chart format. The results are easy to read, and the p-values are stated very clearly. However, no interaction affect was reported.
LIMITATIONS: What are the overall study limitations? (do not only state number of subjects used in study – consider additional limitations besides number of subjects and besides those identified in the article)
A limitation of this study was that in order to provide the best care to the intervention group their physical therapy sessions were focused on utilizing their new reduced muscle tone from the vibration intervention. Because of this it is hard to determine how much of the change on the outcome measures can be attributed to the vibration therapy specifically. More research needs to be done to isolate the vibration therapy from the physical therapy that is associated with it. Additionally, not enough research has been previously done to conclude the correct dosage of vibration therapy. There are many parameters that need to be considered such as amplitude, frequency, and duration. This is a limitation considering the dosage they used in the study is more of an educated guess than proven parameters. The study states that one of its limitations is only including outcome measures that fall under the ICF categories of the body structures and functions and the activities level. They state that if the study is repeated a participation level measure should also be included to have the best understanding of how clinically relevant the changes are in each group. Another limitation is that the study only took place over 3 months. It would strengthen the study to see if the effects of the intervention would last longer than the 3 months that were monitored. My final limitation is that many of the children in the study had three or more accompanying impairments. Impairments such as learning disabilities, seizures, and visual impairments can contribute to motor learning. The study tried to protect against this limitation by doing a subgroup analysis using the children’s GMFCS levels. This analysis proved that there was no difference in the effects of the intervention based on the additional impairments classified by each child’s GMFCS level.
CONCLUSIONS: State the authors’ conclusions related to the research objectives.
The authors concluded that vibration therapy in addition to physical therapy is effective in reducing spasticity and increasing gross motor function in children with Cerebral Palsy. Improvement was seen in both the control and the intervention group however the amount of change between the groups proved the intervention to be statistically significant. Using the clinically significant differences of the GMFM studied by Wang & Yang (2006) the intervention group showed great improvement in motor progression, and the control group showed moderate improvement in motor progression. The study concludes that vibration therapy should be included as a complementary intervention to a current physical therapy program. The authors conclude that more research needs to be done in the future to refine dosage parameters of vibration therapy and the long-term effects of the intervention in children with Cerebral Palsy.