Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT)

Corinne Ammann-Reiffer, Caroline H G Bastiaenen, Andreas D Meyer-Heim, Hubertus J A van Hedel, Corinne Ammann-Reiffer, Caroline H G Bastiaenen, Andreas D Meyer-Heim, Hubertus J A van Hedel

Abstract

Purpose: To investigate the effectiveness of outpatient robot-assisted gait training (RAGT) in ambulatory children with spastic cerebral palsy.

Methods: Children were randomized to two different intervention sequences within a pragmatic crossover design. They performed five weeks of RAGT (3 sessions per week) and five weeks of usual care (UC). Dimension E of the Gross Motor Function Measure-88 (GMFM E) as the primary outcome as well as Dimension D (GMFM D), and timed walking tests were assessed before and after each treatment sequence and after a 5-week follow-up.

Results: The trial was stopped early because of recruitment problems. We included 16 children with a mean age of 11.3 years (6.0-15.3 years). GMFM E median (IQR) change scores were -0.7 (-2.8 to 3.5) after RAGT and 0 (-2.4 to 2.4) after UC. Neither GMFM E nor any secondary outcome measure changed significantly after RAGT or UC, nor were any period, follow-up, or carry-over effects observable.

Conclusions: RAGT as a single intervention was not effective in improving walking abilities in the included children. It should be embedded in a holistic treatment approach, as it cannot cover all aspects relevant to gait. Furthermore, children's personalized rehabilitation goals should be carefully monitored with individualized measurement instruments.

Trial registration: ClinicalTrials.gov NCT00887848.

Keywords: Child; cerebral palsy; crossover design; randomized controlled trial; robotics; walking.

Conflict of interest statement

The authors have no conflict of interest to report.

Figures

Figure 1.
Figure 1.
Overview of the outcome measures and the measurement time points per group. Children randomized to the CTC-group with the intervention sequence usual care/robot-assisted gait training (RAGT)/usual care were measured at four different time points within 16 weeks. Children randomized to the TC-group underwent the intervention sequence RAGT/usual care and were measured at three different time points within 11 weeks. Differences regarding intervention time and numbers of measurement time points were deliberately chosen to reduce the burden on children and families as much as possible.
Figure 2.
Figure 2.
Overview of the study protocol and the statistical analyses. CTC1, baseline assessment in CTC-group; TC1, baseline assessment in TC-group; CTC2, intermediate assessment in CTC-group; TC2, intermediate assessment in TC-group; CTC3, end assessment in CTC-group; TC3, end assessment in TC-group; CTC4, follow-up assessment in CTC-group; ΔC1, change during usual care in CTC-group; ΔC2, change during usual care in TC-group; ΔC3, change during follow-up in CTC-group; ΔT1, change during robot-assisted gait training in TC-group; ΔT2, change during robot-assisted gait training in CTC-group.
Figure 3.
Figure 3.
Individual effects of robot-assisted gait training (RAGT) and usual care on Gross Motor Function Measure dimension E (GMFM E) change scores. The order of the bars reflects the chronological sequence of the treatment. GMFCS, Gross Motor Function Classification Level.

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