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Effectiveness of Different Therapeutic Interventions on the Gait of Children with Down Syndrome Boetz, Lucia; Graetz, Stephanie; McDonald, Colleen; Notooulos, Maria; Harris, Susan; Virji-Babul, Naznin Jul 30, 2007

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The Effects of Therapy on the Gait of Children with Down Syndrome: A Systematic Review  By Lucia Botez, Steph Graetz, Colleen McDonald and Maria Notopoulos  Outline • Background • Methods • Results • Article reviews • Conclusions  • Limitations  Background • Down syndrome (DS) is common1 – 1/700 births  • Due to trisomy of chromosome 21 – 15 and 22 less common1  • Common characteristics1,2: – muscle hypotonia and weakness – ligamentous laxity – gross motor delay  Background • Walking achieved ~1year later than typically developing children3,4,5 • Ambulation has psychosocial consequences6,7 • Parents of children with DS identify walking as most valued milestone8  Courtesy of Naznin-Virji Babul and the Down Syndrome Research Foundation  Background • Common therapy received9 – PT: strength, motor control, function – OT: visual motor and manipulative skills, community participation – SLP: oral motor skills, speech  • Therapy usually starts in infancy9  Can physical therapy effect the gait of these children?  What’s in the literature? • Scarce overall • Many reviews on early intervention and DS – Gibson and Harris 198810 – Nilholm 199611  • Review on motor development and DS – Lautteslager 2006 (Dutch)  Why do this review? • No systematic review on gait and DS • Literature in this area is unfocused • Evidence-based practice • Gait most important gross motor skill9  Objective “To systematically review and rate the levels of evidence and methodological quality of studies that examined the effects of various therapeutic interventions on the gait of children with DS” sk=view&id=1812&Itemid=95  METHODOLOGY  Gabriel House of Mexico  Search Strategy 1. General search in: – CINAHL – EMBASE – ERIC – MEDLINE – PsychINFO  – PubMed – SPORTDiscus – Cochrane – CENTRAL  Autoalerts: OVID, EBSCO  1. Translocation 2. Translocation 3. Translocation 4. down$ 5. mongol$.mp. 6. 7. mental retard$.mp. 8. mental$ handicap$.mp. 9. 10. 11. walk$.mp. 12. train$.mp. 13. physical 14. 15. exercis$.mp.  16. 17. 18. 19. 20. stair 21. physical 22. exercise 23. therapeutic 24. 25. motor 26. swim$.mp. 27. heading word] 28. climb$.mp. 29. active 30. locomot$.mp.  31. ambulat$.mp. 32. run$.mp. 33. step$.mp. 34. 35. 36. 37. pool 38. aqua 39. 40. 41. 42. 43. functional 44. motor 45. movement  46. 47. 48. 49. 50. gross 51. 52. stand$.mp. 53. sit$.mp. 54. 55. 56. 57. 58. physical activit$.mp. 59. rehabil$.mp. 60. strength$.mp.  61. flexib$.mp. 62. manual 63. 64. recreation 65. occupational 66. active therap$.mp. 67.neurodevelopmental 68. stair 69. sport$.mp. 70. mobili$.mp. 71. play$.mp. 72. athelet$.mp. 73. 74. splint$.mp. 75. brac$.mp.  76. orthotic$.mp. 77. social$.mp. 78. measure$.mp. 79. 80. 81. roll$.mp. 82. 83. anti-gravity 84. independ$.mp. 85. grasp$.mp. 86. reach$.mp. 87. step$.mp. 88. jump$.mp. 89.  Selection Protocol - Stage 1 • 2 reviewers independently screened TITLES • If 2 of below criteria, or ambiguous, article was screened further Screening Criteria:  Yes? No?  Title identifies Down syndrome population:  □  □  Title identifies intervention of physical therapy12 (or related interventions):  □  □  Title identifies outcome or effect on gross motor development:  □  □  Title is ambiguous and may have content related to the above:  □  □  Selection Protocol - Stage 2 • 2 reviewers independently screened ABSTRACTS • If all of below criteria, or ambiguous, article was screened further Selection Criteria:  Yes?  No?  Population of Down syndrome  □  □  Population of children (0-17yrs)  □  □  Physical therapy related intervention  □  □  Outcome of gross motor function  □  □  Selection Protocol - Stage 3 • FULL TEXT articles divided among reviewers • Each reviewer extracted population, intervention and outcome data  • A “PICO chart” was created  PICO Chart Ref ID  Population  50 (1)  Not able to retrieve full text article  346 (2)*  14 children w/DS; Age Range: 3-8 years old; independent Ambulation for 30 yards 10 ds (5 experienced sitters 5 nonexperienced)  Flexible SMO’s; 3 testing sessions over 10 weeks  10 DS infants (gr. 1 12.2 mo and gr.2 17 mo)  Visual cues, oscillatory room  412 (3)  585 (4)  Intervention  Moving room oscillated .2 and .5 Hz. Sitting position. 7 days.  Outcomes  Special Notes  Standing, Walking, Running and Jumping Dimensions of GMFM; ROM OPTOTRAK VEP acuity test  SMO’s shown to have +ve influence on postural stability and less complex skills Full text not in English  Trunk sway  There is a coupling that can be improved with practice  Selection Protocol - Stage 3 • Common trends emerged – Early intervention – Vestibular training – Gait (reciprocal bipedal locomotion)  Final Inclusion Criteria • Studies – Peer - reviewed journal, English  Excluded: books, abstracts from conferences  • Population – Clinical diagnosis of DS – 0 - 17 years of age  • Intervention – Any physical therapy related intervention  • Outcome – A variable of gait  Excluded: intervention for parents  Search Strategy 2. Gait specific search: a. Down syndrome b. gait OR locomotion OR walking OR walk c. a AND b  3. Hand-search: • • • • • •  Pediatric Physical Therapy Gait and Posture Ambulatory Pediatrics Journal of Pediatric Healthcare Pediatric Rehabilitation Pediatric Gait: A New Millenium in Clinical Care and Motion Analysis Technology  Search Strategy 4. Forward citation searches on authors 5. Screened reference lists of included articles and background articles 6. Key authors and clinical experts contacted via e-mail  Search Strategy • Articles saved in RefWorks – duplicates removed  • Ceased all search methods in June 2007 Gabriel House of Mexico  Methodological Quality • 2 reviewers independently scored articles using PEDro • Well known in PT community and valid  PEDro Scale (last modified March, 1999): 1. eligibility criteria were specified. 2. subjects were randomly allocated to groups 3. allocation was concealed.  > 6 good to excellent < 5 fair to poor  4. the groups were similar at baseline 5. there was blinding of all subjects. 6. there was blinding of all therapists 7. there was blinding of all outcome assessors. 8. measures of at least one key outcome were obtained from more than 85% of the subjects initially allocated to groups. 9. all subjects for whom outcome measures were available received the treatment or control condition as allocated or, where this was not the case, data for at least one key outcome was analysed by "intention to treat". 10. the results of between-group statistical comparisons are reported for at least one key outcome. 11. the study provides both point measures and measures of variability for at least one key outcome.  Levels of Evidence Levels of Evidence Sackett (2000)13 Level  Description  1a  Meta- analysis or systematic review of randomized clinical trials  1b  Randomized control trial with narrow confidence interval  2a  Systematic review cohort studies  2b  Single randomized clinical trial  3a  Systematic review of case-control studies  3b  Individual case-control study  4  Case series, poor cohort case controlled, including pre-post test  5  Descriptive studies  6  Expert opinion and anecdotal evidence  Data Extraction • Data extraction form made for review • 2 reviewers independently extracted data onto form Gabriel House of Mexico  Disagreement between reviewers at any of the above stages was resolved by 3rd party arbitration  Data Analysis • Data extracted into summary tables – Study characteristics – Outcomes and results  • Calculated Kappa – Stage 1, 2, 3 – PEDro – Levels of Evidence  RESULTS  Search Total studies retrieved from search method #1 N= 5197  K = 0.79  Excluded by screening titles N= 4817 Abstracts retrieved for further screening N= 380 K = 0.86  Excluded by screening abstracts N=316 Studies retrieved for full text analysis N=64 Excluded by evaluating full text N= 54  K= 1  Studies retrieved for PEDro and data extraction N=10 Total studies retrieved from search method #2-6 N= 0  Final number of included articles N=10  Articles • 3 articles on orthoses and 7 on other interventions • Total of 181 children with DS were studied • 8 of 10 studies showed significant or positive results  Methodological Quality Year of Publication/ First Author  Article Title  2004 Martin  Effects of supramalleolar orthoses on postural stability in children with Down syndrome  2001 SelbySilverstein  The effect of foot orthoses on standing foot posture and gait of young children with Down syndrome  2005 Pitetti  Dynamic foot orthosis and motor skills of delayed children  2005 Lafferty  A Stair Walking Intervention Strategy for Children with Down’s Syndrome  2001 Ulrich  Treadmill training of infants with Down syndrome: evidence-based developmental outcomes  PEDro Score (/10)  Kappa Score (/1)  4  1  5  0.8  5  0.8  5  1  6  1  Methodological Quality Year of Publication/ First Author  Article Title  PEDro Score (/10)  Kappa Score (/1)  2002 Winchester  The effect of therapeutic horseback riding on gross motor function and gait speed in children who are developmentally delayed  5  0.8  2003 Uyanik  Comparison of Different Therapy approaches in Children with Down Syndrome  5  0.8  1996 Sayers  Qualitative Analysis of a Pediatric Strength Intervention on the Developmental Stepping Movements of Infants with Down Syndrome  3  1  1984 Esenther  Developmental coaching of the Down syndrome infant  1  0.8  2002 Wang  Promoting balance and jumping skills in children with down syndrome  5  1  Levels of Evidence Group Design Evidence Level  Year / First Author 2004 Martin  Repeated measures  Level 4 2001 Selby-Silverstein  Repeated measures  Level 4 2005 Pitetti  Pre – post  Level 4 2005 Lafferty  Pre - post  Level 4 2001 Ulrich  Randomized control trial  Level 2b  Levels of Evidence Group Design Evidence Level  Year / First Author 2002 Winchester  Repeated measures  Level 4 2003 Uyanik  3 way comparison pre-post  Level 4 1996 Sayers  Exploratory multiple case study  Level 5 1984 Esenther  Retrospective study  Level 4 2002 Wang  Pre-post study  Level 4 K=1  ARTICLE REVIEWS  Orthoses  Orthoses Year/ First Author 2004 Martin14  Group Design/ Evidence Level/ PEDro Repeated Measures Level 4  Intervention  Children wore flexible SMO’s  Control Interventio n  Population/ N  Ages  Shoes only  DS N= 14  3yr6 mo – 8 yrs  DS: Shoes only  DS (n=16) Non-DS (n=10)  36 – 84 mo  8hrs/day; 6 weeks  PEDro 4 2001 Selby-  Repeated Measures  Silverstei n15  Level 4  Children wore FO’s 5hrs/day; 4 consecutive days  PEDro 5 2005 Pitetti16  Pre – post  Children wore Pattibob DFO’s  Level 4 PEDro 5  Frequency unclear; 2 mo and 1 week  Non-DS: No FO’s No DAFO’s  N=26 CP (n=3) DS (n=2) DD (n=20) N=17  46.6 ±10.6 mo DS: 28.0± 1.4 mo  Orthoses Year/ First Author 2004 Martin14  Outcome Gait  Measure GMFM Dimension E: Walking, Running, Jumping Dimension  Results Significant p = 0.0001  2001 Tachometer Gait speed SelbySilverstein1  Non-significant p = 0.09  2005 Pitetti16  Non-significant  5  Gait  PDMS-2 Locomotion Section  Orthoses • Only intervention where multiple studies were conducted • Intervention and population varied • Outcome measures varied • Small sample sizes • Only one control group  Orthoses Clinical recommendation: Clinicians should evaluate orthoses suitability and effectiveness on a case by case basis  Active Therapy / Stair Walking  Active Therapy / Stair Walking Lafferty 200517 Pre – post, Level 4, PEDro 5  Intervention and Population Children participated in a hierarchical active No Control therapy program progressed on ability 3hrs biweekly; 12 weeks  DS N=7  Age= ± 3.4 yrs  Outcome, Measures and Results Kinematic joint angle data for ascent and decent phases  Significant in R. ankle, L. hip and trunk  Observational analysis  Qualitative and quantitative showed improvements in stair walking  Active Therapy / Stair Walking • Whole and part task stair walking practice improvements • Exercises could easily be used in therapy • Study design and methodology assessed as: – Sackett Levels of Evidence: 4 – PEDro score: 5  • Most significant critique – Small sample size of only 7  Clinical recommendation: whole and part task stair walking may be useful to facilitate stair walking in children with DS  Treadmill Training  Treadmill Training Ulrich et al. 20018 Randomized control trial, Level 2b, PEDro 6  Intervention and Population Stepping on a treadmill + traditional PT From 1 – 8 mins, 5 days/week, until independently walking  Control: traditional PT, 2x/week, until independently walking  DS, N=30  Ages:  Control (N=15) Experiment (N=15)  Control (312.1 days±) Experiment (302.6 days±)  Outcome, Measures and Results Independent walking: # of days from onset of study until independent  Significant p=0.02 Experiment: 300 days ± Control: 401 days ±  Treadmill Training • Treadmill training is unique and innovative • Of the reviewed studies it is the highest quality – Sackett Levels of Evidence: 2b – PEDro score: 6  • Outcomes showed statistically significant improvements • ? practicality of implementation for clinicians Clinical recommendation: treadmill training should be considered as a treatment option for infants with DS  Horseback Riding  Horseback Riding Winchester et al. 200218 Repeated Measures, Level 4, PEDro 5  Intervention and Population Horseback riding focusing on stretching, strength, postural Control  No Control  1 hr, once/wk, 7 wks  DS (n=2); CP (n=2); DS and autism (n=1); SB (n=1); TBI (n=1)  Ages 57.886.5 mo  Outcomes, Measures and Results Gait  GMFM Dimension E  Significant at 1 wk and 7 wks post  Gait speed  Time to walk 10 m  Non-significant  Horseback Riding • Previously shown to improve strength and balance in developmentally delayed children19,20 • Sustained improvements at 7 week follow- up • Study design quality and methodology assessed as: – Sackett Levels of Evidence: 4 – PEDro score: 5  • Most significant critique – Small sample size of 7, only 3 had DS  Clinical recommendation: therapeutic horseback riding may be considered for use when treating the gait of children with DS in combination with other therapies  Sensory Integration Therapy, Vestibular Therapy, or Neurodevelopmental Therapy  SIT, Vestibular, NDT Uyanik et al. 200321 3 way comparison pre-post, Level 4, PEDro 5  Intervention and Population Group 1: SIT Group 2: SIT+Vest Group 3: NDT  No Control  1.5 hrs/day, tri-weekly, 3 months  DS: N=45  Ages:  SIT (n=15) SIT+Vest (n=15) NDT (n=15)  SIT: 9.6± SIT+ Vest: 8.67± NDT: 8.53±  Outcome, Measures and Results Time of 10 steps forward walking Time of 10 step sideways walking  SIT and SIT+vest: non-significant NDT: significant SIT and SIT+vest: non-significant NDT: significant  SIT, Vestibular, NDT • Study design quality and methodology assessed as: – Sackett Levels of Evidence: 4 – PEDro score: 5  • One of the largest sample sizes of articles analyzed • Most significant critique – No control group  Clinical recommendation: Since NDT was found to be effective at improving walking skills of children with DS it may be considered a treatment option  Strength Intervention  Strength Intervention Sayers et al. 199622 Exploratory multiple case study, Level 5, PEDro 3  Intervention and Population Individualized strength intervention using ankle weights 1/wk teacher, 3-5/wk with parent; 8 wks  No Control  DS: N= 5  Ages: 22-38 mo  Outcome, Measures and Results HELP strands (Walk/ Run) PMISM (n=3) BDI (Locomotion) Height of step (n=3) Stride Length (n=3)  Improved Improved No change (n=2), improved (n=2) Improved (n=1), improve L. foot (n=1), decline (n=1 Improved (n=1), improve R. foot (n=1), decline R. foot (n=1)  Strength Intervention • Study design quality and methodology assessed as: – Sackett Levels of Evidence: 5 – PEDro score: 3  • Results are difficult to interpret – Qualitative study design – Lack statistical analyses – Small sample size: 1 withdrawal, 1 child incomplete data  • Acknowledging each child’s health needs and individualization of therapy is commended Clinical recommendations: we are unable to draw any clinical conclusions from this research  Developmental Coaching  Developmental Coaching Esenther 198423 Retrospective Study, Level 3, PEDro 1  Intervention and Population Developmental coaching with 3 hand skills, 3 mobility skills targeted  Control: Normative DS values from literature N=40 of typical children  Ages not reported  Duration and frequency of intervention not specified  Outcomes, Measures and Results Independent walking : Bonaparte Infant Parent Service (BIPS) free walking category  40% achieved free walking by 18 months of age  Developmental Coaching • Of the reviewed studies it is the lowest quality – Sackett Levels of Evidence: 4 – PEDro score: 1  • Most significant critique – Retrospective study design without true experimental manipulation – No integrated control group  • Uncertainty of intervention Clinical recommendations: we are unable to draw any clinical conclusions from this research  Jump Training  Jump Training Wang et al. 200224 Pre-Post, Level 4, PEDro 5  Intervention and Population Horizontal and vertical jump practice  Control: Typically developing children  DS N=20  Ages: 3-6 years  30 min practice sessions 3 x/week, 6 weeks  Outcomes, Measures and Results Gait: # of steps walking on a forward line and balance beam  Significantly greater pre-post scores compared to typically developing children  Jump Training • Study design quality and methodology assessed as: – Sackett Levels of Evidence: 4 – PEDro score: 5  • Improvements of only 1-2 additional steps is statistically significant but is it functionally significant ?  Clinical recommendations: balance and jumping had positive (although small) effects, thus, it could be considered as part of a program to improve the gait of children with DS  Conclusions • Current research is a heterogeneous mix of interventions and outcomes • Low quality designs overall • We recommend combinations of different therapies that accommodate child’s specific needs and preferences • We strongly encourage all pediatric therapists to continuously re-evaluate each child’s progress in order to ensure best evidence practice  Future Research • More research must be done • Higher quality research • Optimal treatment parameters • Emerging research25-30  Limitations • Some studies could not be evaluated because full text not in English • Authors lack of expertise in the field of publishing literature • Limited experience in working with children with DS  Acknowledgements Thank you to clinicians and researchers Anne Chin, Bonnie Forrester, Julia Looper, Kenneth Pitetti, Charmayne Ross and Dale Ulrich Special thank you to: Susan Harris Naznin Virji-Babul Charlotte Beck Angela Busch For their support and contributions ☺  References 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.  Goodman CC, Fuller KS, Boissonnault WG. Pathology: Implications for the Physical Therapist. 2nd ed. Philadelphia: Elsevier; 2003. Shields N, Dodd K. A systematic review on the effects of exercise programmes designed to improve strength for people with Down syndrome. Phys Ther Rev. 2004;9:109-115. Carr J. Mental and motor development in young mongol children. J Ment Defic Res. 1970;14:205-220. Hall B. Somatic deviations in newborn and older mongoloid children: Follow up investications. Acta Paediatr Scand. 1970;59:199-204. Share J, Veale AMO. Developmental Landmarks for Children with Down's Syndrome (Mongolism). Dunedin, New Zealand: University of Otago Press; 1974. Harris SR. Physical therapy and infants with down's syndrome: The effects of early intervention. Rehabil Lit. 1981;42:339-343. Bax M. Walking. Dev Med and Child Neur. 1991;33:471-472. Ulrich DA, Ulrich BD, Angulo-Kinzler RM, Yun J. Treadmill training of infants with down syndrome: Evidence-based developmental outcomes. Pediatrics. 2001;108:E84-E84. Jobling A, Virji-Babul N, Nichols D. Children with down syndrome: Discovering the joy of movement. Joperd. 2006;77:34-54. Gibson D, Harris A. Aggregated early intervention effects for Down’ssyndrome persons: patterning and longevity of benefits. J Mental Def Research. 1988;32:1–17. Nilholm C. Early intervention with children with Down syndrome—past and future issues. Down Syndrome: Res Pract. 1996;4:51–58 14th General Meeting World Confederation of Physical Therapy. Description of Physical TherapyWhat is Physical Therapy? Available at: Accessed July/22, 2007.  References 13. 14. 15. 16. 17. 18.  19. 20. 21. 22.  23. 24.  Sackett DL, Strauss SE, Richardson WS. Evidence-Based Medicine: How to Practice and Teach EBM. London: Churchill-Livingstone; 2000. Martin K. Effects of supramalleolar orthoses on postural stability in children with Down syndrome. Developmental Medicine & Child Neurology. 2004;46:406-411. Selby-Silverstein L, Hillstrom HJ, Palisano RJ. The effect of foot orthoses on standing foot posture and gait of young children with down syndrome. Neurorehabilitation. 2001;16:183-193. Pitetti K, Wondra V. Dynamic foot orthosis and motor skills of delayed children. Journal of Prosthetics & Orthotics (JPO). 2005;17:21-26. Lafferty ME. A stair-walking intervention strategy for children with down's syndrome. Journal of Bodywork & Movement Therapies. 2005;9:65-74. Winchester P, Kendall K, Peters H, Sears N, Winkley T. The effect of therapeutic horseback riding on gross motor function and gait speed in children who are developmentally delayed. Phys Occup Ther Pediatr. 2002;22:37-50. Campbell S. Efficacy of therapeutic horseback riding on posture in children with cerebral palsy. Phys Ther. 1990;90:135-140. Bertoti D. Clinical suggestions: Effect of therapeutic horseback riding on posture in children with cerebral palsy. Phys Ther. 1991;10:1505-1512. Uyanik M, Bumin G, Kayihan H. Comparison of different therapy approaches in children with down syndrome. Pediatr Int. 2003;45:68-73. Sayers LK, Cowden JE, Newton M, Warren B, Eason B. Qualitative analysis of a pediatric strength intervention on the developmental stepping movements of infants with down syndrome. Adapted Physical Activity Quarterly. 1996;13:247-268. Esenther SE. Developmental coaching of the down syndrome infant. Am J Occup Ther. 1984;38:440445. Wang W, Ju Y. Promoting balance and jumping skills in children with down syndrome. Percept Mot Skills. 2002;94:443-448.  References Future Research 25.  26. 27. 28. 29.  30.  Looper, Julia E. Ulrich, Dale A. The Effects of Foot Orthoses on Gait in New Walkers with Down syndrome. Pediatric Physical Therapy. 2006;18(1):96-97. Not yet published. Wu, Jianhu. The effect of early treadmill training on gait. Gait and Posture. Not yet published. Ulrich D and Angulo Barroso R. Optimizing treadmill training to improve onset and quality of gait in infants with Down syndrome . Current Research. Ulrich D and Angulo Barroso R. Long term outcomes of preambulatory treadmill training in children with Down syndrome. Current Research. Llpyd M, Ulrich D. Relationship between kicking and motor milestones in infants with Down syndrome: An early intervention study. Current Research. Ulrich D. The effects of learning to ride a two wheel bicycle in 8-15 year old children with Down syndrome: A randomized trial. Current Research.  References Photographs 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23.  Gabriel House of Mexico \  Video 1.  Naznin-Virji Babul. Down Syndrome Research Foundation.  Questions???  


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