Rieducazione robotica del cammino nella persona con sclerosi multipla e disabilità severa del cammino, confronto tra protocolli di intervento. Risultati preliminari e follow-up a tre mesi

Traditional versus progressive robot-assisted gait training in people with multiple sclerosis and severe gait disability: preliminary results with a three-month follow-up.

Autori

Baroni Andrea (Ferrara University, Ferrara, Italy)

Peracchiotti Gabriele (Ferrara University, Ferrara, Italy)

Lamberti Nicola (Ferrara University, Ferrara, Italy)

Manfredini Fabio (Ferrara University, Ferrara, Italy)

Straudi Sofia (Ferrara University, Ferrara, Italy)

Introduction

Gait disorders are frequent in people with multiple sclerosis (PwMS) and the use of robotic devices has been proposed as an effective treatment for gait rehabilitation¹. The use of exoskeletons for gait rehabilitation seems to be effective in PwMS, without showing significant superiority compared to intensive overground gait training (OGT), affected by inter-individual variability of response and problems related to fatigue and spasticity². This study aims to evaluate the effects of a low-intensity RAGT at progressively increasing intensity compared to conventional RAGT and OGT in PwMS and moderate to severe walking impairment³.

Methods

All PwMS afferent to our Department from September 2022 to nowadays were screened for eligibility. Inclusion criteria were men and women aged 18-65 years with diagnosis of MS and disability rate defined by an Expanded Disability Status Scale (EDSS) score from 6 to 7. Patients meeting inclusion criteria were assigned to one of the three treatment groups through a block randomization approach. All participants received three weekly treatment sessions of 3 hours each for 4 weeks. In the first two hours of treatment, each patient received a program characterized by personalization, intensity, and task-specificity of the rehabilitative intervention. During the last hour, subjects will undergo specific gait training according to the assignment group. Subjects allocated to low-intensity RAGT at progressively increasing intensity group will receive gait rehabilitation on the Lokomat device. The device was set at 60% robotic assistance, 50% load suspension, and a speed initially set at 1.0 km/h, with progressive increments of 0.1 km/h at each training session. The working time consisted of bouts of 3 minutes of work alternated by 1 minute of recovery, to be repeated 8 times. Subjects allocated to conventional RAGT group will receive gait rehabilitation on the Lokomat device, and the parameters for setting the machine was determined by a physiotherapist based on patient’s characteristics; the effective duration of treatment was 30 minutes. Subjects allocated to OGT group received one hour walking training session supervised by a physiotherapist. During this time, the subject performed a 40-minute walk on a flat surface with appropriate recovery breaks. Mobility, walking function, balance, and patient-reported outcomes measures (PROMs) were assessed before and after treatment and at the three-month follow-up.

Results

Ninety-five PwMS were screened and twenty-one were enrolled. The three groups were similar in demographic and clinical characteristics at the baseline. All the enrolled subjects completed the study protocol. Significative improvements in walking function, mobility, and balance were recorded at post-treatment evaluation for all three groups, without differences between them. Significative post-treatment changes in PROMs were recorded only for people who received OGT. No improvement was retained at the three-month follow-up.

Discussion and Conclusion

Mobility and gait improvements represent a realistic and achievable goal in PwMS and severe walking impairment. Our preliminary results show that OGT is an effective approach in improving walking function, mobility, and balance, at least as RAGT regardless of the performed training protocol. Changes in PROMs highlighted the superiority of OGT in the subjective perception of disability related to MS. The lack of retention of treatment effects at the three-month follow-up makes it necessary to identify useful strategies to maintain positive changes over time also outside the rehabilitation setting.

REFERENCES

1. Calabrò RS, Cassio A, Mazzoli D, et al. What does evidence tell us about the use of gait Robotic devices in patients with multiple sclerosis? A comprehensive systematic review on functional outcomes and clinical recommendations. Eur J Phys Rehabil Med 2021;57:841–9.
2. Straudi S, Manfredini F, Lamberti N, et al. Robot-assisted gait training is not superior to intensive overground walking in multiple sclerosis with severe disability (the RAGTIME study): a randomized controlled trial. Mult Scler 2020;26:716–24.
3. Baroni A, Lamberti N, Gandolfi M, et al. Traditional versus progressive robot- assisted gait training in people with multiple sclerosis and severe gait disability: study protocol for the PROGR-EX randomised controlled trial. BMJ Open Sport & Exercise Medicine 2024;10:e002039.