Early, Intensive, Lower Extremity Rehabilitation Shows Preliminary Efficacy After Perinatal Stroke: Results of a Pilot Randomized Controlled Trial

Abstract

Background: Perinatal stroke injures motor regions of the brain, compromising movement for life. Early, intensive, active interventions for the upper extremity are efficacious, but interventions for the lower extremity remain understudied.

Objective: To determine the feasibility and potential efficacy of ELEVATE-Engaging the Lower Extremity Via Active Therapy Early-on gross motor function.

Methods: We conducted a single-blind, two-arm, randomized controlled trial (RCT), with the Immediate Group receiving the intervention while the Delay Group served as a 3-month waitlist control. A separate cohort living beyond commuting distance was trained by their parents with guidance from physical therapists. Participants were 8 months to 3 years old, with MRI-confirmed perinatal ischemic stroke and early signs of hemiparesis. The intervention was play-based, focused on weight-bearing, balance and walking for 1 hour/day, 4 days/week for 12 weeks. The primary outcome was the Gross Motor Function Measure-66 (GMFM-66). Secondary outcomes included steps and gait analyses. Final follow-up occurred at age 4.

Results: Thirty-four children participated (25 RCT, 9 Parent-trained). The improvement in GMFM-66 over 12 weeks was greater for the Immediate than the Delay Group in the RCT (average change 3.4 units higher) and greater in younger children. Average step counts reached 1370-3750 steps/session in the last week of training for all children. Parent-trained children also improved but with greater variability.

Conclusions: Early, activity-intensive lower extremity therapy for young children with perinatal stroke is feasible and improves gross motor function in the short term. Longer term improvement may require additional bouts of intervention.

Clinical trial registration: This study was registered at ClinicalTrials.gov (NCT01773369).

Keywords: cerebral palsy; early intervention; exercise; intensive training; motor skill training; neuroplasticity.

Conflict of interest statement

Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Figures

Figure 1.

Experimental Design and MethodsA) A schematic diagram of the experimental design indicating the RCT component (top two rows) and the Parent-trained Group (third row). B) A child demonstrating an example of an activity performed during training. C) Ankle weights were fastened around the lower leg for added strength training, and ¼" chain links were used on the foot to strengthen dorsiflexors. Abbreviations: RCT, randomized controlled trial.

Figure 2.

CONSORT Flow DiagramEligible children entered the randomized controlled trial (RCT) or the Parent-trained cohort if they lived beyond commuting distance. Children in the RCT were allocated to either train immediately (Immediate Group) or delay training for 3 months (Delay Group). The Delay Group served as a usual care control and were trained after the delay period. Children were followed for 3 months after training and reassessed at 4 years old.

Figure 3.

Primary outcome measure: change in Gross Motor Function Measure-66 (GMFM-66)A) Average change scores (i.e., difference between measures at three months and baseline) for the total GMFM-66 score are shown by the bars for each group and change scores for each participant are shown by the white circles. Asterisk indicates p

Figure 4.

Step counts during trainingBlack circles represent the average step count on the affected lower extremity for PT-trained children during the first and final week of training. Gray triangles represent the average step counts for children in the Parent-trained Group. Solid lines represent children who were able to walk independently during the first week of training and dashed lines indicate children who required assistance to walk at the beginning of training. Error bars represent standard error of the mean. Abbreviations: PT, physical therapist.

Figure 5.

Treadmill Walking ResultsA) Average change scores (i.e., difference between measures at three months and baseline) for the toe clearance symmetry score are shown by the bars for each group and change scores for each participant are shown by the white circles. Delay n=13, Immediate n=12, Parent-trained n=9. B) Average change scores for the percent of their body weight a child could independently support are shown by the bars for each group and change scores for each participant are shown by the white circles. Delay n=7, Immediate n=6, Parent-trained n=8.