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. 2023 Jul 26;4:1216281. doi: 10.3389/fresc.2023.1216281

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© 2023 Sachdeva, Girshin, Shirkhani, Gad and Edgerton.

This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

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(A) Experimental design and timeline of events. (B) GMFM88 scores at baseline, week 8, week 16 and follow up. 3 participants started with SCiP™+ ABNT (blue) vs. 3 with sham + ABNT (red). Sham group crossed over to SCiP™ at week 8 and all participants received SCiPTM from week 8 to 16, followed by 10 weeks of no intervention (grey). (C) Mean ± SD change from baseline in GMFM88 scores after 8 weeks of sham, 8 weeks of SCiP™, 16 weeks of SCiP™ and follow up (n = 3 each). (D,E) Comparison of GMFM88 scores at the end of 8 weeks (primary efficacy endpoint) between sham (red) and SCiP™ (blue) groups with reference to a validated predicted model of change in GMFM scores without an intervention, matched for age and GMFCS level (21). (F) spasticity scores (MAS) at baseline, week 8 and week 16 for sham (red) and SCiP™ (blue) groups. (G) Mean ± SD change in spasticity scores suggest that children in therapeutic group had lower spasticity at the end of 8 and 16 weeks, compared to baseline.