Efficacy of baby-CIMT: study protocol for a randomised controlled trial on infants below age 12 months, with clinical signs of unilateral CP

BMC Pediatrics

Kristina Tedroff¹  Lena Krumlinde-Sundholm¹  Linda Ek¹  Lena Sjöstrand¹  Ann-Christin Eliasson¹ 

[1] Neuropediatric Unit, Department of Women’s and Children’s Health, Karolinska Institutet, Stockholm, Sweden

关键词: Early intervention;    Hand function;    Upper limb;    Cerebral Palsy;    Constraint-induced movement therapy;   

Others  :  1138811
DOI  :  10.1186/1471-2431-14-141

 received in 2014-05-02, accepted in 2014-05-22,  发布年份 2014

【 摘 要 】

Background

Infants with unilateral brain lesions are at high risk of developing unilateral cerebral palsy (CP). Given the great plasticity of the young brain, possible interventions for infants at risk of unilateral CP deserve exploration. Constraint-induced movement therapy (CIMT) is known to be effective for older children with unilateral CP but is not systematically used for infants. The development of CIMT for infants (baby-CIMT) is described here, as is the methodology of an RCT comparing the effects on manual ability development of baby-CIMT versus baby-massage. The main hypothesis is that infants receiving baby-CIMT will develop manual ability in the involved hand faster than will infants receiving baby-massage in the first year of life.

Method and design

The study will be a randomised, controlled, prospective parallel-group trial. Invited infants will be to be randomised to either the baby-CIMT or the baby-massage group if they: 1) are at risk of developing unilateral CP due to a known neonatal event affecting the brain or 2) have been referred to Astrid Lindgren Children’s Hospital due to asymmetric hand function. The inclusion criteria are age 3–8 months and established asymmetric hand use. Infants in both groups will receive two 6-weeks training periods separated by a 6-week pause, for 12 weeks in total of treatment. The primary outcome measure will be the new Hand Assessment for Infants (HAI) for evaluating manual ability. In addition, the Parenting Sense of Competence scale and Alberta Infant Motor Scale will be used. Clinical neuroimaging will be utilized to characterise the brain lesion type. To compare outcomes between treatment groups generalised linear models will be used.

Discussion

The model of early intensive intervention for hand function, baby-CIMT evaluated by the Hand Assessment for Infants (HAI) will have the potential to significantly increase our understanding of how early intervention of upper limb function in infants at risk of developing unilateral CP can be performed and measured.

Trial registration

SFO-V4072/2012, 05/22/2013

【 授权许可】

   
2014 Eliasson et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Blauw-Hospers CH, Hadders-Algra M: A systematic review of the effects of early intervention on motor development. Dev Med Child Neurol 2005, 47(6):421-432.
• [2]Orton J, Spittle A, Doyle L, Anderson P, Boyd R: Do early intervention programmes improve cognitive and motor outcomes for preterm infants after discharge? A systematic review. Dev Med Child Neurol 2009, 51(11):851-859.
• [3]Spittle AJ, Boyd RN, Inder TE, Doyle LW: Predicting motor development in very preterm infants at 12 months’ corrected age: the role of qualitative magnetic resonance imaging and general movements assessments. Pediatrics 2009, 123(2):512-517.
• [4]Cioni G, Ferrari F, Einspieler C, Paolicelli PB, Barbani MT, Prechtl HF: Comparison between observation of spontaneous movements and neurologic examination in preterm infants [see comments]. J Pediatrics 1997, 130(5):704-711.
• [5]Skiold B, Eriksson C, Eliasson AC, Aden U, Vollmer B: General movements and magnetic resonance imaging in the prediction of neuromotor outcome in children born extremely preterm. Early Hum Dev 2013, 89(7):467-472.
• [6]Himmelmann K, Hagberg G, Uvebrant P: The changing panorama of cerebral palsy in Sweden. X. Prevalence and origin in the birth-year period 1999–2002. Acta Paediatr 2010, 99(9):1337-1343.
• [7]Husson B, Hertz-Pannier L, Renaud C, Allard D, Presles E, Landrieu P, Chabrier S: Motor outcomes after neonatal arterial ischemic stroke related to early MRI data in a prospective study. Pediatrics 2010, 126(4):912-918.
• [8]Sakzewski L, Ziviani J, Boyd RN: Efficacy of upper limb therapies for unilateral cerebral palsy: a meta-analysis. Pediatrics 2014, 133(1):e175-e204.
• [9]Novak I, McIntyre S, Morgan C, Campbell L, Dark L, Morton N, Stumbles E, Wilson SA, Goldsmith S: A systematic review of interventions for children with cerebral palsy: state of the evidence. Dev Med Child Neurol 2013, 55(10):885-910.
• [10]Nudo RJ, Milliken GW, Jenkins WM, Merzenich MM: Use-dependent alterations of movement representations in primary motor cortex of adult squirrel monkeys. J Neurosci 1996, 16:785-807.
• [11]Eyre JA: Corticospinal tract development and its plasticity after perinatal injury. Neurosci Biobehav Rev 2007, 31(8):1136-1149.
• [12]Eyre JA, Smith M, Dabydeen L, Clowry GJ, Petacchi E, Battini R, Guzzetta A, Cioni G: Is hemiplegic cerebral palsy equivalent to amblyopia of the corticospinal system? Ann Neurol 2007, 62(5):493-503.
• [13]Guzzetta A, Bonanni P, Biagi L, Tosetti M, Montanaro D, Guerrini R, Cioni G: Reorganisation of the somatosensory system after early brain damage. Clin Neurophysiol 2007, 118(5):1110-1121.
• [14]Martin JH, Chakrabarty S, Friel KM: Harnessing activity-dependent plasticity to repair the damaged corticospinal tract in an animal model of cerebral palsy. Dev Med Child Neurol 2011, 53(Suppl 4):9-13.
• [15]Friel KM, Chakrabarty S, Martin JH: Pathophysiological mechanisms of impaired limb use and repair strategies for motor systems after unilateral injury of the developing brain. Dev Med Child Neurol 2013, 55(Suppl 4):27-31.
• [16]Martin JH, Friel KM, Salimi I, Chakrabarty S: Activity- and use-dependent plasticity of the developing corticospinal system. Neurosci Biobehav Rev 2007, 31(8):1125-1135.
• [17]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.
• [18]von Hofsten C: Eye-hand coordination in the newborn. Dev Psychobiology 1982, 18:450-461.
• [19]Bennet GC, Harrold AJ: Prognosis and early management of birth injuries to the brachial plexus. BMJ 1976, 1(6024):1520-1521.
• [20]Fagard J, Jacquet A: Onset of bimanual coordination and symmetry versus asymmetry of movement. Infant Behav Dev 1989, 12:229-235.
• [21]Jacobsohn L, Rodrigues P, Vasconcelos O, Corbetta D, Barreiros J: Lateral manual asymmetries: A longitudinal study from birth to 24 months. Dev Psychobiol 2014, 56(1):58-72.
• [22]Greaves S, Imms C, Krumlinde-Sundholm L, Dodd K, Eliasson AC: Bimanual behaviours in children aged 8–18 months: a literature review to select toys that elicit the use of two hands. Res Dev Disabil 2012, 33(1):240-250.
• [23]Greaves S, Imms C, Dodd K, Krumlinde-Sundholm L: Assessing bimanual performance in young children with hemiplegic cerebral palsy: a systematic review. Dev Med Child Neurol 2010, 52(5):413-421.
• [24]Krumlinde Sundholm L, Ek L, Eliasson AC: What assessments evaluate fine motor performance in infants: a literature review. Dev Med Child Neurolin press
• [25]Eliasson AC, Krumlinde-Sundholm L, Gordon AM, Feys H, Klingels K, Aarts PB, Rameckers E, Autti-Ramo I, Hoare B: Guidelines for future research in constraint-induced movement therapy for children with unilateral cerebral palsy: an expert consensus. Dev Med Child Neurol 2014, 56:125-137.
• [26]Eliasson AC, Shaw K, Berg E, Krumlinde-Sundholm L: An ecological approach of Constraint Induced Movement Therapy for 2-3-year-old children: a randomized control trial. Res Dev Disabil 2011, 32(6):2820-2828.
• [27]Thelen E, Smith LB: A dynamic systems approach to development of cognition and action. Cambridge Massachusetts: MIT press; 1996.
• [28]Smith RA, Wrisberg CA: Motor learning and performance. A problem-based learning approach, vol. 2nd. Baltimore: Human Kinetics Publisher; 2001.
• [29]Bronfenbrenner U, Morris PA: The ecology of developmental processes. In Handbook of Child Phsychology: Vol 1: Theoretical models of human development. Edited by Daman W, Lerner RM. New York: Wiley; 1998:993-1028.
• [30]King S, Teplicky R, King G, Rosenbaum P: Family-centered service for children with cerebral palsy and their families: a review of the literature. Semin Pediatr Neurol 2004, 11(1):78-86.
• [31]Miller W, Rollnick S: Motivational interviewing: Preparing people for change. 2nd edition. New York, NY, US: Guilford Press; 2002.
• [32]Baldwin P, King G, Evans J, McDougall S, Tucker MA, Servais M: Solution-focused coaching in pediatric rehabilitation: an integrated model for practice. Phys Occup Ther Pediatr 2013, 33(4):467-483.
• [33]Kaaresen PI, Ronning JA, Ulvund SE, Dahl LB: A randomized, controlled trial of the effectiveness of an early-intervention program in reducing parenting stress after preterm birth. Pediatrics 2006, 118(1):e9-e19.
• [34]Whittingham K, Wee D, Boyd R: Systematic review of the efficacy of parenting interventions for children with cerebral palsy. Child Care Health Dev 2011, 37(4):475-483.
• [35]Vickers A, Ohlsson A, Lacy J, Horsley A: Massage for promoting growth and development of pretermand/or low birth-weight infants (Review). Cochrane Database Syst Rev 2004, 2:CD000390.
• [36]Bennett C, Underdown A, Barlow A: Massage for promoting mental and physical health in typically developing infants under the age of six months. Cochrane Database Syst Rev 2013, 4:CD005038.
• [37]Abdallah B, Badr LK, Hawwari M: The efficacy of massage on short and long term outcomes in preterm infants. Infant Behav Dev 2013, 36(4):662-669.
• [38]Hernandez-Reif M, Field T, Largie S, Diego M, Manigat N, Seoanes J, Bornstein J: Cerebral palsy symptoms in children decreased following massage therapy. Early Child Dev Care 2005, 175(5):445-456.
• [39]Tronick EZ: Emotions and emotional communication in infants. Am Psychol 1989, 44(2):112-119.
• [40]Schulz KF, Altman DG, Moher D: CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Obstet Gyn 2010, 115(5):1063-1070.
• [41]Ruff HA: Infants’Manipulative Exploration of Objects: Effects of Age and Object Characteristics. Dev Psychology 1984, 20:9-20.
• [42]Soska KC, Galeon MA, Adolph KE: On the other hand: overflow movements of infants’ hands and legs during unimanual object exploration. Dev Psychobiology 2012, 54(4):372-382.
• [43]Novak I, Cusick A, Lannin N: Occupational therapy home programs for cerebral palsy: double-blind, randomized, controlled trial. Pediatrics 2009, 124(4):e606-e614.
• [44]Guzzetta A, Boyd RN, Perez M, Ziviani J, Burzi V, Slaughter V, Rose S, Provan K, Findlay L, Fisher I, Colombini F, Tealdi G, Marchi V, Whittingham K: UP-BEAT (Upper Limb Baby Early Action-observation Training): protocol of two parallel randomised controlled trials of action-observation training for typically developing infants and infants with asymmetric brain lesions. BMJ Open 2013, 3(2):e002512. doi:10.1136/bmjopen-2012-002512. Print 2013
• [45]Johnston C, Mash EJ: A measure of parenting satisfaction and efficacy. J Clinical Child Psychol 1989, 18(2):167-175.
• [46]Gibaud-Wallston J, Wandersman LP: Development and utility of the Parenting Sense of Competence Scale. Toronto, Canada: American Psychological Association; 1978.
• [47]Gilmore L, Cuskelly M: Factor structure of the Parenting Sense of Competence scale using a normative sample. Child Care Health Dev 2009, 35(1):48-55.
• [48]Darrah J, Redfern L, Maguire TO, Beaulne AP, Watt J: Intra-individual stability of rate of gross motor development in full-term infants. Early Hum Dev 1998, 52(2):169-179.
• [49]Darrah J, Piper M, Watt MJ: Assessment of gross motor skills of at-risk infants: predictive validity of the Alberta Infant Motor Scale. Dev Med Child Neurol 1998, 40(7):485-491.
• [50]Pin TW, Eldridge B, Galea MP: Motor trajectories from 4 to 18 months corrected age in infants born at less than 30 weeks of gestation. Early Hum Dev 2010, 86(9):573-580.
• [51]Holmstrom L, Vollmer B, Tedroff K, Islam M, Persson JK, Kits A, Forssberg H, Eliasson AC: Hand function in relation to brain lesions and corticomotor-projection pattern in children with unilateral cerebral palsy. Dev Med Child Neurol 2010, 52(2):145-152.
• [52]Ashwal S, Russman BS, Blasco PA, Miller G, Sandler A, Shevell M, Stevenson R: Practice parameter: diagnostic assessment of the child with cerebral palsy: report of the Quality Standards Subcommittee of the American Academy of Neurology and the Practice Committee of the Child Neurology Society. Neurology 2004, 62(6):851-863.
• [53]Krumlinde-Sundholm L, Holmefur M, Kottorp A, Eliasson AC: The Assisting Hand Assessment: current evidence of validity, reliability, and responsiveness to change. Dev Med Child Neurol 2007, 49(4):259-264.
• [54]Krumlinde-Sundholm L: Reporting outcomes of the Assisting Hand Assessment: what scale should be used? Dev Med Child Neurol 2012, 54(9):807-808.