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

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.

Is robotic gait training effective for individuals with cerebral palsy? A systematic review and meta-analysis of randomized controlled trials

“…The overall effect was not significantly different between the robotic gait training and control intervention for both Gross Motor Function Measure-D (95% CI: −0.29, 0.39; P = 0.77; Figure 4) and -E (95% CI: −0.11, 0.57; P = 0.19; Figure 5). Four of the five studies 18,19,21,22 evaluating Gross Motor Function Measures-D and -E used a Lokomat device, and a Lokomat-specific pooled effect on these measures was also not significantly different from the control interventions tested (GMFM-D 95% CI: −0.25, 0.49; P = 0.52; GMFM-E 95% CI: −0.10, 0.65; P = 0.15; Appendix B).…”

“…Five studies, [17][18][19]21,22 with no significant heterogeneity (Gross Motor Function Measure-D: P = 0.76, I 2 = 0%; Gross Motor Function Measure-E: P = 0.83, I 2 = 0%) and comprising 65 robotic gait training participants and 70 control participants, assessed changes in Gross Motor Function Measure-D and -E scores. The overall effect was not significantly different between the robotic gait training and control intervention for both Gross Motor Function Measure-D (95% CI: −0.29, 0.39; P = 0.77; Figure 4) and -E (95% CI: −0.11, 0.57; P = 0.19; Figure 5).…”

ATLAS2030 Pediatric Gait Exoskeleton: Changes on Range of Motion, Strength and Spasticity in Children With Cerebral Palsy. A Case Series Study

“…Amman-Reiffer et al ( 25 ) found no significant difference in ROM between using conventional physiotherapy and RAGT therapy in children with CP. In this work, an improvement in ROM was observed between the initial session and the end of the study.…”

Robotic-Gait Training in Children and Adolescents with Cerebral Palsy: Choice of Settings and Improvement Opportunities

“…The results from a second study by the same authors also showed improved dynamic balance during walking in children and adolescents with CP following Lokomat training [33]. Finally, only five of these studies [30,[32][33][34][35] were completed in a randomized controlled process, and only three of these studies [23,24,28] provided a short-term follow-up of the observed changes. Moreover, the methodological quality of the included studies ranged from 2 to 7 out of 10, with a median score of 3 (Table 2).…”

“…Moreover, the methodological quality of the included studies ranged from 2 to 7 out of 10, with a median score of 3 (Table 2). Only 5/13 studies [31,[33][34][35][36] were of a good quality (PEDro score ≥ 6). Thus, despite the generally positive effects reported in some of the studies, no consensus has been reached regarding the effectiveness of Lokomat training.…”