Objective: To evaluate feasibility and perform an explanatory analysis of the efficacy of robot-assisted gait training (RAGT) in MS patients with severe walking disabilities (Expanded Disability Status Scale [EDSS] 6.0-7.5) in a pilot trial.
Methods: Prospective, randomized, controlled clinical trial comparing RAGT with conventional walking training (CWT) in a group of stable MS patients (n = 35) during an inpatient rehabilitation stay, 15 sessions over three weeks. All patients participated additionally in a multimodal rehabilitation program. The primary outcome measure was walking velocity and secondary measures were 6-min-walking distance, stride length and knee-extensor strength. All tests were performed by an external blinded assessor at baseline after three weeks and at follow-up after six months. Additionally, Extended Barthel Index (EBI) at entry and discharge was assessed (not blinded), and acceptance/convenience of RAGT rated by patients (Visual Analogue Scale [VAS]) was recorded.
Results: Nineteen patients were randomly allocated to RAGT and 16 patients to CWT. Groups were comparable at baseline. There were 5 drop-outs (2 related directly to treatment) in the RAGT group and 1 in the CWT group, leaving 14 RAGT patients and 15 CWT patients for final analysis. Acceptance and convenience of RAGT as rated by patients were high. Effect sizes were moderate to large, although not significant, for walking velocity (0.700, 95% CI -0.089 to 1.489), walking distance (0.401, 95% CI - 0.370 to 1.172) and knee-extensor strength (right: 1.105, 95% CI 0.278 to 1.932, left 0.650, 95% CI -0.135 to 1.436) favouring RAGT. Prepost within-group analysis revealed an increase of walking velocity, walking distance and knee-extensor strength in the RAGT group, whereas in CWT group only walking velocity was improved. In both groups outcome values returned to baseline at follow-up after six months (n = 23).
Conclusions: Robot-assisted gait training is feasible and may be an effective therapeutic option in MS patients with severe walking disabilities. Effect size calculation and prepost analysis suggest a higher benefit on walking velocity and knee-extensor strength by RAGT compared to CWT. Due to several limitations, however, our results should be regarded as preliminary. Post hoc power calculation showed that two groups of 106 patients are needed to demonstrate a significant moderate effect size of 0.4 after three weeks of RAGT. Thus, further studies with a larger number of patients are needed to investigate the impact of this new treatment option in MS patients.