Intensive therapy following upper limb botulinum toxin A injection in young children with unilateral cerebral palsy: a randomized trial

Abstract

Aim Botulinum toxin A (BoNT‐A) combined with occupational therapy is effective in improving upper limb outcomes in children with unilateral cerebral palsy (CP). It is now essential to identify the most effective therapies following BoNT‐A. Given the added burden for children and families, the aim of this study was to explore whether modified constraint‐induced movement therapy (mCIMT) leads to sufficiently superior gains compared with bimanual occupational therapy (BOT) in young children with unilateral CP following BoNT‐A injections. Method In this randomized, controlled, evaluator‐blinded trial, 34 children (20 males, 14 females; mean age 3y, SD 1y 4mo, range 18mo–6y) with unilateral CP were randomized using concealed allocation to one of two 8‐week interventions. The experimental group (n=17) received BoNT‐A and mCIMT. The comparison group (n=17) received BoNT‐A and BOT. Participants were recruited from a physical rehabilitation clinic and randomized between August 2003 and May 2009. Primary outcome was measured using the Assisting Hand Assessment at 3 months. Secondary outcomes were measured at 3 months and 6 months using the Quality of Upper Extremity Skills Test, the Pediatric Evaluation of Disability Inventory, Canadian Occupational Performance Measure, and the Goal Attainment Scale. Results There were no clinically important differences between groups at baseline. Immediately following intervention, there was no evidence of a superior effect for BoNT‐A + mCIMT as determined by the Assisting Hand Assessment (estimated mean difference [EMD] 0.81, upper 95% confidence limit 3.6; p=0.32) or secondary outcomes. However, both groups showed improvement over time (BoNT‐A + mCIMT: EMD 2.7, 95% confidence interval [CI] 0.7–5.2; BONT‐A + BOT: EMD 4.7, 95% CI 2.1–8.6). Follow‐up at 6 months also demonstrated no superior effect for BoNT‐A + mCIMT. Interpretation Following upper limb injection of BoNT‐A, there was no evidence that mCIMT, despite the significantly increased intensity of the home programme, produced a superior effect across a range of outcomes compared with a structured programme of BOT in young children with unilateral CP.

Efficacy of Upper Limb Therapies for Unilateral Cerebral Palsy: A Meta-analysis

“…Thirteen types of UL interventions and numbers of participants were identified: NDT (2 studies; n = 122), 12,13 intramuscular injections of BoNT-A and OT (11 studies; n = 322), [14][15][16][17][18][19][20][21][22][23][24] cCIMT (3 studies; n = 56), 6,[25][26][27][28] mCIMT (15 studies; n = 578), 7,[29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46][47] hybrid model (mCIMT and bimanual training; 2 studies; n = 68), 8,9 forced-use therapy (2 studies; n = 54), 48,49 HABIT (1 study; n = 20), 50 OT home programs (1 study; n = 35), 51 UL lycra splints (1 study; n = 16), 52 contextfocused therapy (1 study; n = 128), 53 mirror box therapy (1 study; n = 10), 54 acupuncture combined with OT (1 study; n = 75), …”

“…One study reported outcomes for infants ,1 year of age, 6 and 10 studies reported on children ,2 years of age. 12,13,20,29,30,37,40,47,53,55 Most studies targeted children with unilateral CP, and 13 included children with other subtypes of CP (eg, quadriplegia).…”

“…6,26,27,50 Less-intensive, longerduration models delivered intervention over 4 to 10 weeks, ranging from 1 to 3 sessions per week, 1 to 4 hours per session. 8,[29][30][31]37,38,40,42,[44][45][46][47] These models often relied on caregivers to provide varying amounts of home practice to achieve the required dosage of intervention, with the expected total ranging from 15 to 168 hours. 31,37,40,42,44,47 Studies delivered intervention in context at home/ preschool, 26,31,37,40,43,44 in a clinic, [6][7][8]35,41,50 or in the community.…”

“…Short-acting and reversible adverse events reported after BoNT-A injections included nausea and vomiting 18,19,47 and transient weakness. 14,19,20,47 Minor skin irritations were reported after casting for cCIMT.…”

Importance for CP Rehabilitation of Transfer of Motor Improvement to Everyday Life

“…13,14 There are several studies reviewed by Sakzewski et al in which CIMT was delivered in the home. 15,16 Training was implemented in these studies adhering to the guidelines of Novak et al, 17 but no use of the transfer package was reported. Thus, even though training was done in the home, systematic steps were not reported to have been taken to integrate use of the more-affected arm into daily life activities, which the transfer package accomplishes by a variety of means.…”