iMOVE: Intensive Mobility training with Variability and Error compared to conventional rehabilitation for young children with cerebral palsy: the protocol for a single blind randomized controlled trial

Laura A Prosser, Samuel R Pierce, Timothy R Dillingham, Judy C Bernbaum, Abbas F Jawad, Laura A Prosser, Samuel R Pierce, Timothy R Dillingham, Judy C Bernbaum, Abbas F Jawad

Abstract

Background: Cerebral palsy (CP) is the most common cause of physical disability in children. The best opportunity to maximize lifelong independence is early in motor development when there is the most potential for neuroplastic change, but how best to optimize motor ability during this narrow window remains unknown. We have systematically developed and pilot-tested a novel intervention that incorporates overlapping principles of neurorehabilitation and infant motor learning in a context that promotes upright mobility skill and postural control development. The treatment, called iMOVE therapy, was designed to allow young children with CP to self-initiate motor learning experiences similar to their typically developing peers. This manuscript describes the protocol for a subsequent clinical trial to test the efficacy of iMOVE therapy compared to conventional therapy on gross motor development and other secondary outcomes in young children with CP.

Methods: The study is a single-blind randomized controlled trial. Forty-two participants with CP or suspected CP between the ages of 1-3 years will be randomized to receive either the iMOVE or conventional therapy group. Distinguishing characteristics of each group are detailed. Repeated measures of gross motor function will be collected throughout the 12-24 week intervention phase and at three follow-up points over one year post therapy. Secondary outcomes include measures of postural control, physical activity, participation and caregiver satisfaction.

Discussion: This clinical trial will add to a small, but growing, body of literature on early interventions to optimize the development of motor control in young children with CP. The information learned will inform clinical practice of early treatment strategies and may contribute to improving the trajectory of motor development and reducing lifelong physical disability in individuals with CP.

Trial registration: ClinicalTrials.gov identifier NCT02340026 . Registered January 16, 2015.

Keywords: Cerebral palsy; Children; Motor control; Motor learning; Motor training; Physical therapy; Rehabilitation.

Conflict of interest statement

Ethics approval and consent to participate

All study procedures have received human subjects ethics approval from The Children’s Hospital of Philadelphia Institutional Review Board (IRB). Informed consent will be obtained from a legal guardian for each study participant. The requirement for assent of minors has been waived due to the age of the participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

References

    1. Pakula AT, Van Naarden Braun K, Yeargin-Allsopp M. Cerebral palsy: classification and epidemiology. Phys Med Rehabil Clin N Am. 2009;20(3):425–452. doi: 10.1016/j.pmr.2009.06.001.
    1. Colver A, Fairhurst C, Pharoah PO. Cerebral palsy. Lancet. 2014;383(9924):1240–1249. doi: 10.1016/S0140-6736(13)61835-8.
    1. Kirby RS, Wingate MS, Van Naarden Braun K, Doernberg NS, Arneson CL, Benedict RE, et al. Prevalence and functioning of children with cerebral palsy in four areas of the United States in 2006: a report from the autism and developmental disabilities monitoring network. Res Dev Disabil. 2011;32(2):462–469. doi: 10.1016/j.ridd.2010.12.042.
    1. Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997;39(4):214–223. doi: 10.1111/j.1469-8749.1997.tb07414.x.
    1. Chiarello LA, Huntington A, Bundy A. A comparison of motor behaviors, interaction, and playfulness during mother-child and father-child play with children with motor delay. Phys Occup Ther Pediatr. 2006;26(1–2):129–151. doi: 10.1080/J006v26n01_09.
    1. Palisano RJ, Kang LJ, Chiarello LA, Orlin M, Oeffinger D, Maggs J. Social and community participation of children and youth with cerebral palsy is associated with age and gross motor function classification. Phys Ther. 2009;89(12):1304–1314. doi: 10.2522/ptj.20090162.
    1. Mc Manus V, Corcoran P, Perry IJ. Participation in everyday activities and quality of life in pre-teenage children living with cerebral palsy in south West Ireland. BMC Pediatr. 2008;8:50. doi: 10.1186/1471-2431-8-50.
    1. Donkervoort M, Roebroeck M, Wiegerink D, van der Heijden-Maessen H, Stam H. Determinants of functioning of adolescents and young adults with cerebral palsy. Disabil Rehabil. 2007;29(6):453–463. doi: 10.1080/09638280600836018.
    1. Michelsen SI, Uldall P, Hansen T, Madsen M. Social integration of adults with cerebral palsy. Dev Med Child Neurol. 2006;48(8):643–649. doi: 10.1017/S0012162206001368.
    1. Beckung E, Carlsson G, Carlsdotter S, Uvebrant P. The natural history of gross motor development in children with cerebral palsy aged 1 to 15 years. Dev Med Child Neurol. 2007;49(10):751–756. doi: 10.1111/j.1469-8749.2007.00751.x.
    1. Palisano RJ, Cameron D, Rosenbaum PL, Walter SD, Russell D. Stability of the gross motor function classification system. Dev Med Child Neurol. 2006;48(6):424–428. doi: 10.1017/S0012162206000934.
    1. McCormick A, Brien M, Plourde J, Wood E, Rosenbaum P, McLean J. Stability of the gross motor function classification system in adults with cerebral palsy. Dev Med Child Neurol. 2007;49(4):265–269. doi: 10.1111/j.1469-8749.2007.00265.x.
    1. Gorter JW, Ketelaar M, Rosenbaum P, Helders PJ, Palisano R. Use of the GMFCS in infants with CP: the need for reclassification at age 2 years or older. Dev Med Child Neurol. 2009;51(1):46–52. doi: 10.1111/j.1469-8749.2008.03117.x.
    1. Friel K, Chakrabarty S, Kuo HC, Martin J. Using motor behavior during an early critical period to restore skilled limb movement after damage to the corticospinal system during development. J Neurosci. 2012;32(27):9265–9276. doi: 10.1523/JNEUROSCI.1198-12.2012.
    1. Cioni G, D’Acunto G, Guzzetta A. Perinatal brain damage in children: neuroplasticity, early intervention, and molecular mechanisms of recovery. Prog Brain Res. 2011;189:139–154. doi: 10.1016/B978-0-444-53884-0.00022-1.
    1. Krishnan RV. Relearning of locomotion in injured spinal cord: new directions for rehabilitation programs. Int J Neurosci. 2003;113(10):1333–1351. doi: 10.1080/00207450390231446.
    1. Damiano DL, Alter KE, Chambers H. New clinical and research trends in lower extremity management for ambulatory children with cerebral palsy. Phys Med Rehabil Clin N Am. 2009;20(3):469–491. doi: 10.1016/j.pmr.2009.04.005.
    1. Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, et al. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007;109:8–14.
    1. Wolf SL, Winstein CJ, Miller JP, Taub E, Uswatte G, Morris D, et al. Effect of constraint-induced movement therapy on upper extremity function 3 to 9 months after stroke: the EXCITE randomized clinical trial. JAMA. 2006;296(17):2095–2104. doi: 10.1001/jama.296.17.2095.
    1. Horn SD, DeJong G, Smout RJ, Gassaway J, James R, Conroy B. Stroke rehabilitation patients, practice, and outcomes: is earlier and more aggressive therapy better? Arch Phys Med Rehabil. 2005;86(12 Suppl 2):S101–SS14. doi: 10.1016/j.apmr.2005.09.016.
    1. Dobkin B, Barbeau H, Deforge D, Ditunno J, Elashoff R, Apple D, et al. The evolution of walking-related outcomes over the first 12 weeks of rehabilitation for incomplete traumatic spinal cord injury: the multicenter randomized spinal cord injury Locomotor trial. Neurorehabil Neural Repair. 2007;21(1):25–35. doi: 10.1177/1545968306295556.
    1. Nudo RJ. Adaptive plasticity in motor cortex: implications for rehabilitation after brain injury. J Rehabil Med. 2003;41 Suppl:7–10. doi: 10.1080/16501960310010070.
    1. Hlustik P, Solodkin A, Noll DC, Small SL. Cortical plasticity during three-week motor skill learning. J Clin Neurophysiol. 2004;21(3):180–191. doi: 10.1097/00004691-200405000-00006.
    1. Winchester P, McColl R, Querry R, Foreman N, Mosby J, Tansey K, et al. Changes in supraspinal activation patterns following robotic locomotor therapy in motor-incomplete spinal cord injury. Neurorehabil Neural Repair. 2005;19(4):313–324. doi: 10.1177/1545968305281515.
    1. Harbourne RT, Stergiou N. Movement variability and the use of nonlinear tools: principles to guide physical therapist practice. Phys Ther. 2009;89(3):267–282. doi: 10.2522/ptj.20080130.
    1. Cai LL, Fong AJ, Otoshi CK, Liang Y, Burdick JW, Roy RR, et al. Implications of assist-as-needed robotic step training after a complete spinal cord injury on intrinsic strategies of motor learning. J Neurosci. 2006;26(41):10564–10568. doi: 10.1523/JNEUROSCI.2266-06.2006.
    1. Lewek MD, Cruz TH, Moore JL, Roth HR, Dhaher YY, Hornby TG. Allowing intralimb kinematic variability during locomotor training poststroke improves kinematic consistency: a subgroup analysis from a randomized clinical trial. Phys Ther. 2009;89(8):829–839. doi: 10.2522/ptj.20080180.
    1. Kleim JA, Jones TA. Principles of experience-dependent neural plasticity: implications for rehabilitation after brain damage. J Speech Lang Hear Res. 2008;51(1):S225–S239. doi: 10.1044/1092-4388(2008/018).
    1. Krebs HI, Volpe B, Hogan N. A working model of stroke recovery from rehabilitation robotics practitioners. J Neuroeng Rehabil. 2009;6:6. doi: 10.1186/1743-0003-6-6.
    1. Torres-Oviedo G, Bastian AJ. Natural error patterns enable transfer of motor learning to novel contexts. J Neurophysiol. 2012;107(1):346–356. doi: 10.1152/jn.00570.2011.
    1. Patton JL, Stoykov ME, Kovic M, Mussa-Ivaldi FA. Evaluation of robotic training forces that either enhance or reduce error in chronic hemiparetic stroke survivors. Exp Brain Res. 2006;168(3):368–383. doi: 10.1007/s00221-005-0097-8.
    1. Hornby TG, Campbell DD, Kahn JH, Demott T, Moore JL, Roth HR. Enhanced gait-related improvements after therapist- versus robotic-assisted locomotor training in subjects with chronic stroke: a randomized controlled study. Stroke. 2008;39(6):1786–1792. doi: 10.1161/STROKEAHA.107.504779.
    1. Galloway JC, Thelen E. Feet first: object exploration in young infants. Infant Behavior & Development. 2004;27(1):107–112. doi: 10.1016/j.infbeh.2003.06.001.
    1. Adolph KE, Cole WG, Komati M, Garciaguirre JS, Badaly D, Lingeman JM, et al. How do you learn to walk? Thousands of steps and dozens of falls per day. Psychol Sci. 2012;23(11):1387–1394. doi: 10.1177/0956797612446346.
    1. Joh AS, Adolph KE. Learning from falling. Child Dev. 2006;77(1):89–102. doi: 10.1111/j.1467-8624.2006.00858.x.
    1. Adolph KE. Learning to move. Curr Dir Psychol Sci. 2008;17(3):213–218. doi: 10.1111/j.1467-8721.2008.00577.x.
    1. Thelen E. Determinants of amounts of stereotyped behavior in Normal human infants. Ethol Sociobiol. 1980;1(2):141–150. doi: 10.1016/0162-3095(80)90004-7.
    1. Prosser LA, Ohlrich LB, Curatalo LA, Alter KE, Damiano DL. Feasibility and preliminary effectiveness of a novel mobility training intervention in infants and toddlers with cerebral palsy. Dev Neurorehabil. 2012;15(4):259–266. doi: 10.3109/17518423.2012.687782.
    1. Rounsaville BJ, Carroll KM, Onken LS. A stage model of behavioral therapies research: getting started and moving on from stage I. Clinical Psychology-Science and Practice. 2001;8(2):133–142. doi: 10.1093/clipsy.8.2.133.
    1. Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, et al. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013;158(3):200–207. doi: 10.7326/0003-4819-158-3-201302050-00583.
    1. McIntyre S, Morgan C, Walker K, Novak I. Cerebral palsy--don't delay. Dev Disabil Res Rev. 2011;17(2):114–129. doi: 10.1002/ddrr.1106.
    1. McMillan JA, Feigin RD, DeAngelis C, Jones MD. Oski’s pediatrics: principles & practice. 4th ed. Philadelphia: Lippincott Williams & Wilkins; 2006.
    1. Surveillance of Cerebral Palsy in Europe Surveillance of cerebral palsy in Europe: a collaboration of cerebral palsy surveys and registers. Surveillance of Cerebral Palsy in Europe (SCPE) Dev Med Child Neurol. 2000;42(12):816–824. doi: 10.1017/S0012162200001511.
    1. Lee JH, Lim HK, Park E, Song J, Lee HS, Ko J, et al. Reliability and applicability of the Bayley scale of infant development-II for children with cerebral palsy. Ann Rehabil Med. 2013;37(2):167–174. doi: 10.5535/arm.2013.37.2.167.
    1. Bayley N. Bayley scales of infant and toddler development. Third. Harcourt Assessment, Inc: San Antonio; 2006.
    1. Russell DJ, Rosenbaum PL, Avery LM, Lane M. Gross motor function measure (GMFM-66 & GMFM-88) User’s manual. London: Mac Keith Press; 2002.
    1. Russell DJ, Avery LM, Rosenbaum PL, Raina PS, Walter SD, Palisano RJ. Improved scaling of the gross motor function measure for children with cerebral palsy: evidence of reliability and validity. Phys Ther. 2000;80(9):873–885.
    1. Hanna SE, Bartlett DJ, Rivard LM, Russell DJ. Reference curves for the gross motor function measure: percentiles for clinical description and tracking over time among children with cerebral palsy. Phys Ther. 2008;88(5):596–607. doi: 10.2522/ptj.20070314.
    1. Palisano RJ, Begnoche DM, Chiarello LA, Bartlett DJ, McCoy SW, Chang HJ. Amount and focus of physical therapy and occupational therapy for young children with cerebral palsy. Phys Occup Ther Pediatr. 2012;32(4):368–382. doi: 10.3109/01942638.2012.715620.
    1. Duncan PW, Sullivan KJ, Behrman AL, Azen SP, Wu SS, Nadeau SE, et al. Body-weight-supported treadmill rehabilitation after stroke. N Engl J Med. 2011;364(21):2026–2036. doi: 10.1056/NEJMoa1010790.
    1. McCoy SW, Bartlett DJ, Yocum A, Jeffries L, Fiss AL, Chiarello L, et al. Development and validity of the early clinical assessment of balance for young children with cerebral palsy. Dev Neurorehabil. 2014;17(6):375–383. doi: 10.3109/17518423.2013.827755.
    1. Randall KE, Bartlett DJ, McCoy SW. Measuring postural stability in young children with cerebral palsy: a comparison of 2 instruments. Pediatr Phys Ther. 2014;26(3):332–337. doi: 10.1097/PEP.0000000000000062.
    1. Dusing SC, Kyvelidou A, Mercer VS, Stergiou N. Infants born preterm exhibit different patterns of center-of-pressure movement than infants born at full term. Phys Ther. 2009;89(12):1354–1362. doi: 10.2522/ptj.20080361.
    1. Carswell A, McColl MA, Baptiste S, Law M, Polatajko H, Pollock N. The Canadian occupational performance measure: a research and clinical literature review. Can J Occup Ther. 2004;71(4):210–222. doi: 10.1177/000841740407100406.
    1. Chiarello LA, Palisano RJ, McCoy SW, Bartlett DJ, Wood A, Chang HJ, et al. Child engagement in daily life: a measure of participation for young children with cerebral palsy. Disabil Rehabil. 2014;36(21):1804–1816. doi: 10.3109/09638288.2014.882417.
    1. Campos JJ, Anderson DI, Barbu-Roth MA, Hubbard EM, Hertenstein MJ, Witherington D. Travel broadens the mind. Infancy. 2000;1(2):149–219. doi: 10.1207/S15327078IN0102_1.
    1. Lynch A, Ryu JC, Agrawal S, Galloway JC. Power mobility training for a 7-month-old infant with spina bifida. Pediatr Phys Ther. 2009;21(4):362–368. doi: 10.1097/PEP.0b013e3181bfae4c.
    1. Law MC, Darrah J, Pollock N, Wilson B, Russell DJ, Walter SD, et al. Focus on function: a cluster, randomized controlled trial comparing child- versus context-focused intervention for young children with cerebral palsy. Dev Med Child Neurol. 2011;53(7):621–629. doi: 10.1111/j.1469-8749.2011.03962.x.
    1. The Databrary Project. A video data library for developmental science [Internet]: New York University; 2012. Available from: .
    1. Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–381. doi: 10.1016/j.jbi.2008.08.010.
    1. Laird NM, Ware JH. Random-effects models for longitudinal data. Biometrics. 1982;38(4):963–974. doi: 10.2307/2529876.
    1. Zeger SL, Liang KY. Longitudinal data analysis for discrete and continuous outcomes. Biometrics. 1986;42(1):121–130. doi: 10.2307/2531248.
    1. Morgan C, Novak I, Dale RC, Guzzetta A, Badawi N. GAME (goals - activity - motor enrichment): protocol of a single blind randomised controlled trial of motor training, parent education and environmental enrichment for infants at high risk of cerebral palsy. BMC Neurol. 2014;14:203. doi: 10.1186/s12883-014-0203-2.
    1. Harbourne RT, Dusing SC, Lobo MA, Westcott-McCoy S, Bovaird J, Sheridan S, et al. Sitting together and reaching to play (START-play): protocol for a multisite randomized controlled efficacy trial on intervention for infants with Neuromotor disorders. Phys Ther. 2018;98(6):494–502. doi: 10.1093/ptj/pzy033.

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