Effects of a Soft Robotic Exoskeleton for Gait Training on Clinical Outcomes in Patients With Parkinson Disease: Randomized Controlled Pilot

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BackgroundBalance and gait disorders in Parkinson disease (PD) impair motor function and quality of life.ObjectiveEvidence on soft exoskeleton robots (SERs) for PD rehabilitation is limited. This study evaluated the impact of SERs on motor dysfunction in PD.MethodsA total of 56 people with PD (July 2023 to May 2024) were randomized to 2 groups: the control group (n=25, 44.6%) received conventional rehabilitation, and the experimental group (n=31, 55.4%) received conventional rehabilitation combined with SER training (ChiCTR2500111990). Training occurred 5 times per week for 20 minutes each session over 4 weeks. Primary outcomes included gait speed and stride length, while secondary outcomes assessed the percentage of swing phase, ankle joint range of motion, Unified Parkinson Disease Rating Scale total and motor scores, and Montreal Cognitive Assessment. Paired sample t tests (2-tailed) were used for within-group pre- and postintervention comparisons, and independent sample t tests (2-tailed) were used for between-group comparisons. Correlation analyses were conducted between gait parameters and improvements in ankle mobility.ResultsAfter 4 weeks, the experimental group showed significant improvements in gait and balance. Specifically, left stride length increased by a mean of 0.15 (SD 0.16; 95% CI 0.09-0.21) m (PConclusionsSER-assisted training significantly improves gait, balance, and PD symptoms. Our work integrates multidimensional assessments (gait analysis, balance metrics, and clinical scales) and reveals that gains in ankle mobility directly correlate with gait improvements, suggesting a key mechanism. This study contributes by establishing SER as an effective adjunct to conventional therapy, supported by comprehensive quantitative data.

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