Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial

Alicia J Hilderley, Darcy Fehlings, Gloria W Lee, F Virginia Wright, Alicia J Hilderley, Darcy Fehlings, Gloria W Lee, F Virginia Wright

Abstract

Background: Enhancement of functional ambulation is a key goal of rehabilitation for children with cerebral palsy (CP) who experience gross motor impairment. Physiotherapy (PT) approaches often involve overground and treadmill-based gait training to promote motor learning, typically as free walking or with body-weight support. Robotic-assisted gait training (RAGT), using a device such as the Lokomat®Pro, may permit longer training duration, faster and more variable gait speeds, and support walking pattern guidance more than overground/treadmill training to further capitalize on motor learning principles. Single group pre-/post-test studies have demonstrated an association between RAGT and moderate to large improvements in gross motor skills, gait velocity and endurance. A single published randomized controlled trial (RCT) comparing RAGT to a PT-only intervention showed no difference in gait kinematics. However, gross motor function and walking endurance were not evaluated and conclusions were limited by a large PT group drop-out rate.

Methods/design: In this two-group cross-over RCT, children are randomly allocated to the RAGT or PT arm (each with twice weekly sessions for eight weeks), with cross-over to the other intervention arm following a six-week break. Both interventions are grounded in motor learning principles with incorporation of individualized mobility-based goals. Sessions are fully operationalized through manualized, menu-based protocols and post-session documentation to enhance internal and external validity. Assessments occur pre/post each intervention arm (four time points total) by an independent assessor. The co-primary outcomes are gross motor functional ability (Gross Motor Function Measure (GMFM-66) and 6-minute walk test), with secondary outcome measures assessing: (a) individualized goals; (b) gait variables and daily walking amounts; and (c) functional abilities, participation and quality of life. Investigators and statisticians are blinded to study group allocation in the analyses, and assessors are blinded to treatment group. The primary analysis will be the pre- to post-test differences (change scores) of the GMFM-66 and 6MWT between RAGT and PT groups.

Discussion: This study is the first RCT comparing RAGT to an active gait-related PT intervention in paediatric CP that addresses gait-related gross motor, participation and individualized outcomes, and as such, is expected to provide comprehensive information as to the potential role of RAGT in clinical practice. Trial registration ClinicalTrials.gov NCT02196298.

Keywords: Cerebral palsy; Gait; Orthotic devices; Physical therapy modalities; Robotics.

Figures

Fig. 1
Fig. 1
Flowchart of enrolment according to CONSORT guidelines. *CDP: Child Development Program at Holland Bloorview Kids Rehabilitation Hospital, Toronto, Canada. **Baseline Assessments occur

References

    1. Aurich Schuler T, Warken B, Graser JV, et al. Practical recommendations for robot-assisted treadmill therapy (Lokomat) in children with cerebral palsy: indications, goal setting, and clinical implementation within the WHO-ICF framework. Neuropediatrics. 2015;46:248–260. doi: 10.1055/s-0035-1550150.
    1. Baker K, Goggins J, Xie H, et al. A randomized crossover trial of a wedged insole for treatment of knee osteoarthritis. Arthr Rheumatol. 2007;56:1198–1203. doi: 10.1002/art.22516.
    1. Bar-Haim S, Harries N, Nammourah I, et al. Effectiveness of motor learning coaching in children with cerebral palsy: a randomized controlled trial. Clin Rehabil. 2010;24:1009–1020. doi: 10.1177/0269215510371428.
    1. Bjornson KF, Belza B, Kartin D, et al. Ambulatory physical activity performance in youth with cerebral palsy and youth who are developing typically. Phys Ther. 2007;87:248–257. doi: 10.2522/ptj.20060157.
    1. Bjornson KF, Zhou C, Stevenson R, et al. Walking activity patterns in youth with cerebral palsy and youth developing typically. Disabil Rehabil. 2014;36:1279–1284. doi: 10.3109/09638288.2013.845254.
    1. Borggraefe I, Kiwull L, Schaefer JS, et al. Sustainability of motor performance after robotic-assisted treadmill therapy in children: an open, non-randomized baseline-treatment study. Eur J Phys Rehabil Med. 2010;46:125–131.
    1. Borggraefe I, Schaefer JS, Klaiber M, et al. Robotic-assisted treadmill therapy improves walking and standing performance in children and adolescents with cerebral palsy. Eur J Paediatr Neurol. 2010;14:496–502. doi: 10.1016/j.ejpn.2010.01.002.
    1. Bottos M, Gericke C. Ambulatory capacity in cerebral palsy: prognostic criteria and consequences for intervention. Dev Med Child Neurol. 2003;45:786–790. doi: 10.1111/j.1469-8749.2003.tb00890.x.
    1. Bottos M, Feliciangeli A, Sciuto L, et al. Functional status of adults with cerebral palsy and implications for treatment of children. Dev Med Child Neurol. 2001;43:516–528. doi: 10.1017/S0012162201000950.
    1. Brütsch K, Schuler T, Koenig A, et al. Influence of virtual reality soccer game on walking performance in robotic assisted gait training for children. J Neuroeng Rehabil. 2010;7:15. doi: 10.1186/1743-0003-7-15.
    1. Castelli E. Robotic movement therapy in cerebral palsy. Dev Med Child Neurol. 2011;53:481. doi: 10.1111/j.1469-8749.2011.03987.x.
    1. Chan A-W, Tetzlaff JM, Gøtzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Chrysagis N, Skordilis EK, Stavrou N, et al. The effect of treadmill training on gross motor function and walking speed in ambulatory adolescents with cerebral palsy: a randomized controlled trial. Am J Phys Med Rehabil. 2012;91:747–760. doi: 10.1097/PHM.0b013e3182643eba.
    1. Dobkin BH, Duncan PW. Should body weight-supported treadmill training and robotic-assistive steppers for locomotor training trot back to the starting gate? Neurorehabil Neural Repair. 2012;26:308–317. doi: 10.1177/1545968312439687.
    1. Druzbicki M, Rusek W, Snela S, et al. Functional effects of robotic-assisted locomotor treadmill therapy in children with cerebral palsy. J Rehabil Med. 2013;45:358–363. doi: 10.2340/16501977-1114.
    1. Drużbicki M, Rusek W, Szczepanik M, et al. Assessment of the impact of orthotic gait training on balance in children with cerebral palsy. Acta Bioeng Biomech. 2010;12:53–58.
    1. Eisenberg S, Zuk L, Carmeli E, Katz-Leurer M. Contribution of stepping while standing to function and secondary conditions among children with cerebral palsy. Pediatr Phys Ther. 2009;21:79–85. doi: 10.1097/PEP.0b013e31818f57f2.
    1. Gibson BE, Teachman G, Wright V, et al. Children’s and parents’ beliefs regarding the value of walking: rehabilitation implications for children with cerebral palsy. Child Care Health Dev. 2012;38:61–69. doi: 10.1111/j.1365-2214.2011.01271.x.
    1. Glazebrook CM, Wright FV. Measuring advanced motor skills in children with cerebral palsy: further development of the challenge module. Pediatr Phys Ther. 2014;26:201–213. doi: 10.1097/PEP.0000000000000035.
    1. Haley SM, Coster WJ, Ludlow LH, et al. Pediatric evaluation of disability inventory (PEDI) San Antonio: Pearson Clinical; 1992.
    1. Hanna SE, Rosenbaum PL, Bartlett DJ, et al. Stability and decline in gross motor function among children and youth with cerebral palsy aged 2 to 21 years. Dev Med Child Neurol. 2009;51:295–302. doi: 10.1111/j.1469-8749.2008.03196.x.
    1. Harris PA. Research electronic data capture (redcap)-planning, collecting and managing data for clinical and translational research. BMC Bioinform. 2012;13:A15. doi: 10.1186/1471-2105-13-S12-A15.
    1. Hintze J. NCSS and PASS. Kaysville: Number Cruncher Statistical Systems; 2001.
    1. Johnston TE, Watson KE, Ross SA, et al. Effects of a supported speed treadmill training exercise program on impairment and function for children with cerebral palsy. Dev Med Child Neurol. 2011;53:742–750. doi: 10.1111/j.1469-8749.2011.03990.x.
    1. Kamath T, Pfeifer M, Banerjee-Guenette P, et al. Reliability of the motor learning strategy rating instrument for children and youth with acquired brain injury. Phys Occup Ther Pediatr. 2012;32:288–305. doi: 10.3109/01942638.2012.672551.
    1. King GA, McDougall J, Palisano RJ, et al. Goal attainment scaling: its use in evaluating pediatric therapy programs. Phys Occup Ther Pediatr. 2000;19:31–52.
    1. King GA, Law M, King S, et al. Measuring children’s participation in recreation and leisure activities: construct validation of the CAPE and PAC. Child Care Health Dev. 2007;33:28–39. doi: 10.1111/j.1365-2214.2006.00613.x.
    1. Koenig A, Wellner M, Köneke S, et al. Virtual gait training for children with cerebral palsy using the Lokomat gait orthosis. Stud Health Technol Inform. 2008;132:204–209.
    1. Koenig A, Omlin X, Bergmann J, et al. Controlling patient participation during robot-assisted gait training. J Neuroeng Rehabil. 2011;8:14. doi: 10.1186/1743-0003-8-14.
    1. Law M, Baptiste S, McColl M, et al. The Canadian occupational performance measure: an outcome measure for occupational therapy. Can J Occup Ther. 1990;57:82–87. doi: 10.1177/000841749005700207.
    1. Law M, Russell D, Pollock N, et al. A comparison of intensive neurodevelopmental therapy plus casting and a regular occupational therapy program for children with cerebral palsy. Dev Med Child Neurol. 1997;39:664–670. doi: 10.1111/j.1469-8749.1997.tb07360.x.
    1. Lepage C, Noreau L, Bernard PM. Association between characteristics of locomotion and accomplishment of life habits in children with cerebral palsy. Phys Ther. 1998;78:458–469.
    1. Levac D, Wishart L, Missiuna C, Wright V. The application of motor learning strategies within functionally based interventions for children with neuromotor conditions. Pediatr Phys Ther. 2009;21:345–355. doi: 10.1097/PEP.0b013e3181beb09d.
    1. Louis TA, Lavori PW, Bailar JC, Polansky M. Crossover and self-controlled designs in clinical research. N Engl J Med. 1984;310:24–31. doi: 10.1056/NEJM198401053100106.
    1. Mayr A, Kofler M, Quirbach E, et al. Prospective, blinded, randomized crossover study of gait rehabilitation in stroke patients using the Lokomat gait orthosis. Neurorehabil Neural Repair. 2007;21:307–314. doi: 10.1177/1545968307300697.
    1. McDougall J, Wright V, Rosenbaum P. The ICF model of functioning and disability: incorporating quality of life and human development. Dev Neurorehabil. 2010;13:204–211. doi: 10.3109/17518421003620525.
    1. McKeever P, Rossen BE, Scott H, et al. The significance of uprightness: parents’ reflections on children’s responses to a hands-free walker for children. Disabil Soc. 2013;28:380–392. doi: 10.1080/09687599.2012.714259.
    1. McNee AE, Will E, Lin J-P, et al. The effect of serial casting on gait in children with cerebral palsy: preliminary results from a crossover trial. Gait Posture. 2007;25:463–468. doi: 10.1016/j.gaitpost.2006.08.002.
    1. Meyer-Heim A, van Hedel HJA. Robot-assisted and computer-enhanced therapies for children with cerebral palsy: current state and clinical implementation. Semin Pediatr Neurol. 2013;20:139–145. doi: 10.1016/j.spen.2013.06.006.
    1. Meyer-Heim A, Borggraefe I, Ammann-Reiffer C, et al. Feasibility of robotic-assisted locomotor training in children with central gait impairment. Dev Med Child Neurol. 2007;49:900–906. doi: 10.1111/j.1469-8749.2007.00900.x.
    1. Meyer-Heim A, Ammann-Reiffer C, Schmartz A, et al. Improvement of walking abilities after robotic-assisted locomotion training in children with cerebral palsy. Arch Dis Child. 2009;94:615–620. doi: 10.1136/adc.2008.145458.
    1. Miller L, Marnane K, Ziviani J, Boyd RN. The Dimensions of Mastery Questionnaire in school-aged children with congenital hemiplegia: test–retest reproducibility and parent–child concordance. Phys Occup Ther Pediatr. 2014;34:168–184. doi: 10.3109/01942638.2013.806978.
    1. Moore JB, Yin Z, Hanes J, et al. Measuring enjoyment of physical activity in children: validation of the physical activity enjoyment scale. J Appl Sport Psychol. 2009;21:S116–S129. doi: 10.1080/10413200802593612.
    1. 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;55:885–910. doi: 10.1111/dmcn.12246.
    1. 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;50:918–925. doi: 10.1111/j.1469-8749.2008.03150.x.
    1. Oskoui M, Coutinho F, Dykeman J, et al. An update on the prevalence of cerebral palsy: a systematic review and meta-analysis. Dev Med Child Neurol. 2013;55:509–519. doi: 10.1111/dmcn.12080.
    1. Pajaro-Blazquez M, Shetye R, Gallegos-Salazar J, Bonato P. Robotic-assisted gait training in children with cerebral palsy in clinical practice. Converg Clin Eng Res Neurorehabil Biosyst Biorobot. 2013;1:29–33. doi: 10.1007/978-3-642-34546-3_5.
    1. Palisano RJ, Rosenbaum P, Bartlett D, Livingston MH. Content validity of the expanded and revised Gross Motor Function Classification System. Developmental Medicine & Child Neurology. 2008;50(10):744–750. doi: 10.1111/j.1469-8749.2008.03089.x.
    1. Park E-Y, Kim W-H. Structural equation modeling of motor impairment, gross motor function, and the functional outcome in children with cerebral palsy. Res Dev Disabil. 2013;34:1731–1739. doi: 10.1016/j.ridd.2013.02.003.
    1. Park ES, Park CI, Kim JY. Comparison of anterior and posterior walkers with respect to gait parameters and energy expenditure of children with spastic diplegic cerebral palsy. Yonsei Med J. 2001;42:180–184. doi: 10.3349/ymj.2001.42.2.180.
    1. Peterson MD, Gordon PM, Hurvitz EA. Chronic disease risk among adults with cerebral palsy: the role of premature sarcopoenia, obesity and sedentary behaviour. Obes Rev. 2013;14:171–182. doi: 10.1111/j.1467-789X.2012.01052.x.
    1. Phelan SK, Wright V, Gibson BE. Representations of disability and normality in rehabilitation technology promotional materials. Disabil Rehabil. 2014;36:2072–2079. doi: 10.3109/09638288.2014.891055.
    1. Pool D, Blackmore AM, Bear N, Valentine J. Effects of short-term daily community walk aide use on children with unilateral spastic cerebral palsy. Pediatr Phys Ther. 2014;26:308–317. doi: 10.1097/PEP.0000000000000057.
    1. Ravens-Sieberer U, Auquier P, Erhart M, et al. The KIDSCREEN-27 quality of life measure for children and adolescents: psychometric results from a cross-cultural survey in 13 European countries. Qual Life Res. 2007;16:1347–1356. doi: 10.1007/s11136-007-9240-2.
    1. Russell DJ, Wright M, Rosenbaum PL, et al. Improved scaling of the gross motor function measure for children with cerebral palsy: evidence of reliability and validity. Phys Ther. 2000;80:873–885.
    1. Russell DJ, Rosenbaum PL, Wright M, Avery LM. Gross motor function measure (GMFM-66 and GMFM-88) user’s manual. 2. Hoboken: Wiley; 2013.
    1. Schindl MR, Forstner C, Kern H, Hesse S. Treadmill training with partial body weight support in nonambulatory patients with cerebral palsy. Arch Phys Med Rehabil. 2000;81:301–306. doi: 10.1016/S0003-9993(00)90075-3.
    1. Scholtes VA, Becher JG, Beelen A, Lankhorst GJ. Clinical assessment of spasticity in children with cerebral palsy: a critical review of available instruments. Dev Med Child Neurol. 2006;48:64–73. doi: 10.1017/S0012162206000132.
    1. Schroeder AS, Homburg M, Warken B, et al. Prospective controlled cohort study to evaluate changes of function, activity and participation in patients with bilateral spastic cerebral palsy after Robot-enhanced repetitive treadmill therapy. Eur J Paediatr Neurol. 2014;18:502–510. doi: 10.1016/j.ejpn.2014.04.012.
    1. Schroeder AS, Von Kries R, Riedel C, et al. Patient-specific determinants of responsiveness to robot-enhanced treadmill therapy in children and adolescents with cerebral palsy. Dev Med Child Neurol. 2014;56:1172–1179. doi: 10.1111/dmcn.12564.
    1. Schulz KF, Altman DG, Moher D, CONSORT Group CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. J Clin Epidemiol. 2010;63:834–840. doi: 10.1016/j.jclinepi.2010.02.005.
    1. Senn S. Cross-over trials in clinical research. 2. West Sussex: Wiley; 2002.
    1. Sorsdahl AB, Moe-Nilssen R, Strand LI. Test–retest reliability of spatial and temporal gait parameters in children with cerebral palsy as measured by an electronic walkway. Gait Posture. 2008;27:43–50. doi: 10.1016/j.gaitpost.2007.01.001.
    1. Strifling KMB, Lu N, Wang M, et al. Comparison of upper extremity kinematics in children with spastic diplegic cerebral palsy using anterior and posterior walkers. Gait Posture. 2008;28:412–419. doi: 10.1016/j.gaitpost.2008.01.018.
    1. Stuberg WA. Considerations related to weight-bearing programs in children with developmental disabilities. Phys Ther. 1992;72:35–40.
    1. Tefertiller C, Pharo B, Evans N, Winchester P. Efficacy of rehabilitation robotics for walking training in neurological disorders: a review. J Rehabil Res Dev. 2011;48:387–416. doi: 10.1682/JRRD.2010.04.0055.
    1. Thompson P, Beath T, Bell J, et al. Test-retest reliability of the 10-metre fast walk test and 6-minute walk test in ambulatory school-aged children with cerebral palsy. Dev Med Child Neurol. 2008;50:370–376. doi: 10.1111/j.1469-8749.2008.02048.x.
    1. Verschuren O, Darrah J, Novak I, et al. Health-enhancing physical activity in children with cerebral palsy: more of the same is not enough. Phys Ther. 2014;94:297–305. doi: 10.2522/ptj.20130214.
    1. Wang M, Reid D. Virtual reality in pediatric neurorehabilitation: attention deficit hyperactivity disorder, autism and cerebral palsy. Neuroepidemiology. 2011;36:2–18. doi: 10.1159/000320847.
    1. Wiart L. Exploring mobility options for children with physical disabilities: a focus on powered mobility. Phys Occup Ther Pediatr. 2011;31:16–18. doi: 10.3109/01942638.2011.532452.
    1. Williams EN, Carroll SG, Reddihough DS, et al. Investigation of the timed “Up & Go” test in children. Dev Med Child Neurol. 2005;47:518–524. doi: 10.1017/S0012162205001027.
    1. Willoughby KL, Dodd KJ, Shields N. A systematic review of the effectiveness of treadmill training for children with cerebral palsy. Disabil Rehabil. 2009;31:1971–1979. doi: 10.3109/09638280902874204.
    1. Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988;14:9–17.
    1. Wood L, Egger M, Gluud LL, et al. Empirical evidence of bias in treatment effect estimates in controlled trials with different interventions and outcomes: meta-epidemiological study. BMJ. 2008;336:601–605. doi: 10.1136/.
    1. World Health Organization . International classification of functioning, disability and health (ICF) Geneva: World Health Organization; 2001.
    1. World Health Organization (2007) International classification of functioning, disability, and health. Children and Youth Version: ICF-CY. World Health Organization
    1. Wright FV, Redekop S, Koo I, et al. Reliability of a new observational gait scale for evaluation of outcomes related to botulinum toxin type-A injections in children with cerebral palsy. Dev Med Child Neurol. 2008;50(suppl4):32.
    1. Wright V, Shircore LE, Fehlings D, Lee G. Reliability of the challenge module for children with cerebral palsy in GMFCS Level I. Dev Med Child Neurol. 2012;54:30–79.
    1. Wright FV, Rosenbaum P, Fehlings D, et al. The Quality Function Measure: reliability and discriminant validity of a new measure of quality of gross motor movement in ambulatory children with cerebral palsy. Dev Med Child Neurol. 2014;56:770–778. doi: 10.1111/dmcn.12453.
    1. Yelling M, Lamb KL, Swaine I. Validity of a pictorial perceived exertion scale for effort estimation and effort production during stepping exercise in adolescent children. Eur Phys Educ Rev. 2002;8:157–175. doi: 10.1177/1356336X020082007.
    1. Young NL, Williams JI, Yoshida KK, Wright JG. Measurement properties of the activities scale for kids. J Clin Epidemiol. 2000;53:125–137. doi: 10.1016/S0895-4356(99)00113-4.
    1. Zwicker JG, Mayson TA. Effectiveness of treadmill training in children with motor impairments. Pediatr Phys Ther. 2010;22:361–377. doi: 10.1097/PEP.0b013e3181f92e54.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi