THE EFFECTS OF WHOLE BODY VIBRATION THERAPY IN CHILDREN WITH CEREBRAL PALSY: A META- ANALYSIS

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1 THE EFFECTS OF WHOLE BODY VIBRATION THERAPY IN CHILDREN WITH CEREBRAL PALSY: A META- ANALYSIS Lauren Cochran, DPTc UCSF/SFSU Graduate Program in Physical Therapy

2 CEREBRAL PALSY (CP) Motor impairment resulting from insult or injury to the brain before or soon after birth o Non-progressive o Cerebral = brain o Palsy = muscle weakness Affects one or more limbs and often the trunk Increased risk with prematurity and low birth weight (Aisen 2011, Campbell 2006, Colver 2014)

3 CLINICAL PRESENTATION Weakness and decreased muscle activity Spasticity and/or abnormal tone Sensation Impairments Activity Limitations Walking Activities of daily living Balance Difficulty with: School activities Peer interactions Recreational activities Participation Restrictions (Christensen 2014, Campbell 2006, Gatica 2014, Colver 2014)

4 IMPACT OF CEREBRAL PALSY Most common motor disability of childhood cases out of every 1000 live births Estimated lifetime cost of nearly $1 million Not including indirect costs Often seen with additional conditions Intellectual disability Seizure disorder Vision impairments Hearing impairments Joint changes contractures, scoliosis (CDC 2013)

5 RELEVANCE TO PHYSICAL THERAPY No cure for CP, but treatment is comprehensive and lifelong o Pharmacological o Surgical o Orthotics o Physical therapy o Occupational therapy o Speech therapy Physical therapy addresses common impairments, activity limitations, and participation restrictions: o o o Balance Strength Gait/mobility o o o Joint motion Endurance Posture and alignment (Campbell 2006)

6 OUTCOME MEASURES: GMFM Gross Motor Function Measure (GMFM): tool to assess change in gross motor function. Five domains tested Section D evaluates standing activities (Russel et al. 1989)

7 OUTCOME MEASURES: GAIT SPEED AND STRENGTH Gait Speed: distance walked in specified time Requires pre-measured distance and timer Correlated with participation level in activities that require ambulation Strength: amount of force produced by a muscle Dynamometer Correlated with functional motor skills

8 CLINICAL PROBLEM Cerebral palsy is the most common diagnosis seen by pediatric physical therapists. Children with CP are often limited in activities requiring efficient gait, standing ability, and strength. Many interventions for children with CP have limited evidence demonstrating efficacy. (Mattern-Baxter 2009, Novak 2013)

9 WHOLE BODY VIBRATION (WBV) Vibrating platform with handles Adjustable parameters o Amplitude (mm) and Frequency (Hz) Wide range of devices and treatment protocols o Several bouts of vibration exposure per session (i.e., three minutes of activity and rest) (Rauch 2009)

10 WBV IN ACTION

11 USE OF WBV IN HEALTHY POPULATIONS Claimed to improve: o Weight loss o Strength o Balance o Sport performance o Bone density o Vertical jump (South Coast Spine Center)

12 EXISTING EVIDENCE FOR WBV Parkinson s Disease (Sharififar 2014) Benefit for mobility and balance; but not compared to other active intervention or placebo Spinal Cord Injury (Sadeghi 2014) WBV resulted in decreased spasticity lasting for 6-8 days after the last vibration session Stroke (Yang, 2014) No evidence for effects of WBV on balance; inconclusive effects on mobility and gait Multiple Sclerosis (Santos-Filho 2012) Some evidence for improvements in muscle strength, functional mobility, and TUG scores

13 QUESTION: PICO Foreground Question: Does whole body vibration therapy affect gait, strength, and/or standing ability in children with cerebral palsy? Population Intervention Control Outcome Children with CP; 5-13 years old Whole body vibration therapy or whole body vibration + physical therapy Standard physical therapy or standing on floor with no vibration Gait, strength, standing ability (GMFM, D)

14 HYPOTHESIS Null Hypothesis WBV therapy will have no effect on gait, strength, and/or standing ability in children with CP Alternative Hypothesis WBV therapy will improve strength, gait, and/or standing ability in children with CP Expectation 4-5 articles studying the effect of WBV on strength, gait and standing ability. Expect to reject null hypothesis.

15 VIBRATION THERAPY THEORY No consensus regarding how WBV may affect muscle function o A variety of physiological effects have been noted: Tonic vibration reflex: Skin blood o flow Muscle contraction (Rauch 2009, Rittwegger 2010) o Muscle power IGF-1 and cortisol Muscles alternate between stretching Oxygen and shortening phases consumption Transition between eccentric and concentric muscle contractions Whole Muscle temp Body Vibration

16 THEORETICAL CONSTRUCT If If whole body vibration causes contraction of agonist and antagonist muscles then then it may increase lower extremity strength and stability in children with cerebral palsy.

17 THEORETICAL CONSTRUCT If If whole body vibration has impacted strength, gait, and function in adults with neurological diagnoses then then it may have a similar effect on strength, gait, and function in children with cerebral palsy.

18 THE GAP IN THE LITERATURE Multiple studies have examined effects of vibration therapy as a therapeutic modality for children with CP o Inconclusive evidence regarding benefits o Inconclusive evidence regarding areas of impact o Lack of pooled evidence Purpose: This meta-analysis aims to determine if whole body vibration impacts gait, strength, and/or standing ability in children with cerebral palsy.

19 METHODS: SEARCH PROCEDURES Search terms (in combination): whole body vibration, vibration therapy, cerebral palsy Databases: PEDro, CINAHL, PubMed, Cochrane Last search conducted: December 28, 2014

20 METHODS: SEARCH PROCEDURES Inclusion WBV applied in standing or semi-standing Outcome measures examining gait, GMFM (D), and/or strength Level II evidence, or higher Published in English Exclusion Insufficient study duration (ie: one treatment session) Focal or ultrasonic vibration modalities Studied effects of anything other than WBV

21 METHODS: STUDY SELECTION

22 STATISTICAL ANALYSES Effect sizes, within and between groups 95% confidence intervals Q-statistic to assess homogeneity Grand effect size and 95% confidence intervals

23 Study SUMMARY OF STUDIES Level of Evidence El-Shamy (2014) Ib RCT Ibrahim (2014) IIb RCT Lee (2013) Ib RCT Ruck (2010) IIb RCT Wren (2010) IIb Study Design Participants Intervention Prospective randomized crossover 30 children, ages 8-12, with spastic diplegia CP 30 children, ages 8-12, with spastic diplegia CP 30 children with spastic diplegia or quadriplegia CP 20 children, ages , with CP (type unspecified) 30 children, ages , with CP (type unspecified) WBV + PT vs. PT WBV + PT vs. Study Duration 3 months Outcomes Reported Knee extensor strength Knee extensor strength, Gait speed, GMFM, PT 3 months WBV + PT vs. PT 8 weeks Gait speed WBV + PT vs. PT 6 months Gait speed, GMFM WBV vs. static standing 6 months Concentric calf strength

24 QUALITY ASSESSMENT USING THE PEDro SCALE PEDro criterion Study Reported in study El-Shamy Ibraham Lee Ruck Wren Elibility criteria specified yes yes yes yes yes Random allocation yes yes yes yes yes Concealed allocation yes no yes yes yes Baseline comparability yes yes yes yes yes Blinded subjects no no no no no Blinded therapists no no no no no Blinded assessors yes no yes no yes Adequate follow-up yes no yes no yes Intention-to-treat analysis yes no no no no Between-group comparisons yes yes yes yes yes Point estimates and variability yes yes yes yes yes Total score (out of 10)

25 HARM AND ADVERSE EVENTS No adverse events were observed in studies reporting on adverse events Some report of temporary fatigue, stomachache, headache, and/or redness Avoidance of excessive vibration to the organs and/or head by requiring a flexed hip and knee posture during intervention

26 COST Cost was not reported in any of the studies, but can be estimated 20 min to treat 1 PT to treat $175-$13,000 per unit, plus maintenance (Google.com/shopping)

27 RESULTS: GAIT SPEED, WITHIN GROUPS WBV had a statistically significant effect on increasing gait speed. Effect size: 2.06 (0.78, 3.35) Calculated using the Random Effects Model; Q=11.9 Increasing gait speed

28 RESULTS: GAIT SPEED, BETWEEN GROUPS WBV had a significantly greater effect on gait speed than control intervention. Effect size: 2.08 (0.67, 3.49) Increasing gait speed Calculated using the Random Effects Model; Q=11.67

29 RESULTS: STRENGTH, WITHIN GROUPS WBV had a statistically significant effect on increasing strength. Effect size: 5.08 (1.10, 9.05) Increasing strength Calculated using the Random Effects Model; Q=56.35

30 RESULTS: STRENGTH, BETWEEN GROUPS WBV did not have a significantly greater effect than control interventions on strength. Effect Size: 2.80 (-0.62, 6.22) Increasing strength Calculated using the Random Effects Model; Q=58.9

31 RESULTS: GMFM, DOMAIN D, WITHIN GROUPS WBV did not have a statistically significant effect on improving GMFM score. Effect size: 0.85 (-0.44, 2.14) Increasing score Calculated using the Random Effects Model; Q=6.06

32 RESULTS: GMFM, DOMAIN D, BETWEEN GROUPS WBV had a significantly greater effect on GMFM score than control intervention. Effect size: 0.83 (0.22,1.44) Calculated using the Fixed Effects Model, Q=1.63 Increasing score

33 DISCUSSION: Does WBV affect gait, strength, and/or standing ability in children with CP? Gait Speed After intervention Compared to to control Strength After intervention Compared to control GMFM Score After intervention Compared to to control Partially reject the null hypothesis of no difference

34 SIGNIFICANCE: GAIT SPEED WBV improved gait speed: 0.31 m/s improvement after intervention period About 1 foot per second; 60 feet per minute MCID: 9.1% Clinically significant improvement in gait speed Can make a difference in getting around a school campus and participating in activities with peers

35 SIGNIFICANCE: GMFM, DOMAIN D WBV improved score on GMFM, Domain D o Increased by 3.32 points (8.52%) after intervention period MCID: 1.8 points Clinically significant improvement in standing ability: Sit to stand, standing from floor, single leg stand, etc. (Oeffinger, et al. 2008)

36 SIGNIFICANCE: STRENGTH WBV improved LE strength o 4.40 N after intervention period o 17% increase in strength o May improve ambulation and transfers Outliers: Wren et al. Not more effective than control intervention o May still be useful for children with limited ability to participate

37 OUTLIER IN THE STRENGTH ANALYSIS Within-groups Between-groups

38 WREN ET AL: STUDY DESIGN 10 continuous minutes of vibration Versus 3 min on/3 min off GMFCS Gross Motor Function Classification System: based on selfinitiated movement, functional limitations, the need for assistive devices or wheeled mobility, and quality of movement. No standard physical therapy included Versus standard PT in both control and intervention Level I: Walks without limitations Level II: Walks with limitations Inclusion of GMFCS Levels I-IV El-Shamy included levels I-II only Level III: Walks using hand-held mobility device Level IV: Self mobility with limitations Level V: Transported in manual wheelchair / Kids-exercising-with-ball--Stock-Vector-kidsexercise-cartoon.jpg boy-in-wheelchair.jpg

39 EXCLUDING WREN ET AL. Between-groups comparison: o Statistically significant improvement in strength in intervention group compared to control group 4.21 (3.29, 5.12)

40 OUTLIER IN THE GMFM ANALYSIS Within-groups Between-groups

41 RUCK ET AL. STUDY DESIGN 90% of participants GMFCS Levels III-IV Ibrahim et al. used patients who were able to walk Utilized a tilt table to introduce WBV Not all participants reached full vertical position Results reported as median and interquartile range Within group data estimated from given data Vector-illustration-of-Happy-boy-Stock-Vector-cartoon.jpg

42 POTENTIAL BENEFITS OF WBV Relative short treatment time (20 minutes) No adverse events reported; minimal complaint Possibly useful for patients unable to participate in other therapy activities Cost involves one time purchase, no training requirements

43 POTENTIAL DRAWBACKS OF WBV Cost between $175-$13,000 Requires patient be able to assume standing/semi standing Disliked by some patients ( boring ) Limited number of facilities with resources

44 LIMITATIONS Studies included small numbers of participants Lack of double-blinding Lack of assessment of carryover Within-group results estimated from change scores for one article Lack of homogeneity between studies Research conducted by single individual

45 CLINICAL IMPLICATIONS Additional evidence-based treatment idea Not a replacement for existing therapy Feasible treatment to complete at home 02/wetnose / Kids-exercisingwith-ball--Stock-Vector-kids-exercise-cartoon.jpg

46 FUTURE DIRECTION Perform More studies with larger sample size Explore Other modes of vibration Impact on bone density and spasticity Determine Optimal WBV protocol Additional populations that may benefit

47 CONCLUSION WBV may be a useful tool for increasing gait, strength, and standing ability in children with cerebral palsy when combined with traditional physical therapy.

48 PRIMARY REFERENCES Lee B, Chon S. Clinical Rehabilitation doi: / Ruck J, Chabot G, Rauch F. Vibration treatment in cerebral palsy : A randomized controlled pilot study. 2010;10(January): Ibrahim MM. Effect of whole-body vibration on muscle strength, spasticity, and motor performance in spastic diplegic cerebral palsy children. Egypt. J. Med. Hum. Genet. 2014;15(2): doi: /j.ejmhg El-Shamy, et al. Effect of Whole-Body Vibration on Muscle Strength and Balance in. 2014;93(2): doi: /phm.0b013e3182a541a4. Wren TAL, Ph D, Lee DC, et al. NIH Public Access. 2011;30(7):

49 SECONDARY REFERENCES Aisen ML, Kerkovich D, Mast J, et al. Cerebral palsy: clinical care and neurological rehabilitation. Lancet Neurol. 2011;10(9): Borenstein M, Hedges L, Rothestein H. Meta-Analysis: Fixed effect vs. random effects Analysis.com. Campbell SK, Palisano RJ, Linden DW. Physical Therapy for Children. W B Saunders Company; Christensen D, Van naarden braun K, Doernberg NS, et al. Prevalence of cerebral palsy, co-occurring autism spectrum disorders, and motor functioning - Autism and Developmental Disabilities Monitoring Network, USA, Dev Med Child Neurol. 2014;56(1): Colver A, Fairhurst C, Pharoah PO. Cerebral palsy. Lancet. 2014;383(9924): Division of Birth Defects and Developmental Disabilities, National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention Available at: Gatica VF, Irene velásquez S, Méndez GA, Guzmán EE, Manterola CG. [Differences in standing balance in patients with cerebral palsy and typically developing children]. Biomedica. 2014;34(1): Maher CG, Sherrington C, Herbert RD, Moseley AM, Elkins M. Reliability of the PEDro scale for rating quality of randomized controlled trials. Phys Ther. 2003;83: Mattern-Baxter K. Effects of partial body weight supported treadmill training on children with cerebral palsy. Pediatr Phys Ther. 2009;21:12-22.

50 SECONDARY REFERENCES Novak I, Mcintyre S, Morgan C, et al. A systematic review of interventions for children with cerebral palsy: State of the evidence. Dev Med Child Neurol. 2013;55: Oeffinger D, Bagley A, Rogers S, et al. Outcome tools used for ambulatory children with cerebral palsy: Responsiveness and minimum clinically important differences. Dev Med Child Neurol. 2008;50: Rauch F. Vibration therapy. Dev Med Child Neurol. 2009;51 Suppl 4: Rittweger J. Vibration as an exercise modality: How it may work, and what its potential might be. Eur J Appl Physiol. 2010;108: doi: /s Russell DJ, Rosenbaum PL, Cadman DT, Gowland C, Hardy S, Jarvis S. The gross motor function measure: a means to evaluate the effects of physical therapy. Dev Med Child Neurol. 1989;31: Sadeghi M, Sawatzky B. Effects of vibration on spasticity in individuals with spinal cord injury: a scoping systematic review. Am J Phys Med Rehabil. 2014;93(11): Santos-filho SD, Cameron MH, Bernardo-filho M. Benefits of whole-body vibration with an oscillating platform for people with multiple sclerosis: a systematic review. Mult Scler Int. 2012;2012: Sharififar S, Coronado RA, Romero S, Azari H, Thigpen M. The effects of whole body vibration on mobility and balance in Parkinson disease: a systematic review. Iran J Med Sci. 2014;39(4): South Coast Spine Center. Power Plate San Diego. South Coast Spine Center Available at Yang X, Wang P, Liu C, He C, Reinhardt JD. The effect of whole body vibration on balance, gait performance and mobility in people with stroke: A systematic review and meta-analysis. Clin Rehabil. 2014;

51 ACKNOWLEDGEMENTS Theresa Jaramillo, PT, MS, DPT Valerie Block, DPTSc Diane Allen, PT, PhD Sheena McCormack, DPTc Siobhan McOsker, DPTc UCSF/SFSU DPT Class of

52 QUESTIONS??