Engaging the Lower Extremity via Active Therapy Early (ELEVATE) Is Feasible and May Improve Gross Motor Function in Children with Spastic Bilateral Cerebral Palsy: A Case Series.

Abstract

The feasibility of ELEVATE with respect to adherence and preliminary efficacy was determined for children with spastic bilateral cerebral palsy (CP) from encephalopathy of prematurity. A case series was used. Participants were randomized to receive ELEVATE immediately or delay the intervention by 3 months before receiving the intervention. The outcomes included feasibility measures of (1) number of children recruited, (2) percentage of sessions attended, (3) stride counts during the intervention, and preliminary efficacy measures of change over the intervention period in (4) Gross Motor Function Measure-66 (GMFM-66), and (5) kinematics and weight-bearing during treadmill walking. Four boys under 3 years of age participated. All participants tolerated 60-minute intervention sessions four times/week for 12 weeks, and attended 75%-94% (min-max) of the targeted sessions. The median step count per session ranged from 833 to 2484 steps (min-max) during the final week of training. Participants showed an increase in GMFM-66 score of 2.4-7.5 points (min-max) over the 3-month intervention phase, as compared to a decrease of 1.7 for one participant and an increase of 1.3 for another over the delay period. Three participants demonstrated small improvements in their gait with the intervention. Engaging young children with bilateral CP in intensive rehabilitation targeting gross motor function was feasible and demonstrated preliminary efficacy. The results have guided the design of a larger clinical trial to assess efficacy of early, active interventions for children with spastic bilateral CP.